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A Novel Approach to Plantar Fasciitis in the Aging Population (NAPA)

Primary Purpose

Plantar Fasciitis, Chronic

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
minimal shoes and foot strengthening and flexibility exercises
Supportive Footwear, foot orthotic device and foot flexibility exercises
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis, Chronic focused on measuring minimal footwear, pain, function, strengthening

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1 Active plantar fasciitis for a minimum of 6 months. 2. Heel/arch pain on first step in the morning, 3. Heel/arch pain with prolonged standing (>15 min), 4. Heel/arch pain with prolonged walking (>15 min), 5. Be able to stand and walk for 10 minutes with little or no pain (<3/10 on a NRPS). Exclusion Criteria: Having systemic disease such as diabetes, gout, arthritis, neuropathy, surgical reconstructions Having a history of heel surgery or had a steroid injection for heel pain in the past 6 months. Used foot orthoses less than 3 months before start date of study. Having used minimal shoes at any time in the past. No special or vulnerable populations will be recruited.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Minimal Footwear (Vivobarefoot)

    Supportive Footwear

    Arm Description

    The experimental intervention involves the combination of foot strengthening/stretching and minimal footwear to promote the foot strengthening beyond the exercise program to mitigate weakening from chronic support.

    The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.

    Outcomes

    Primary Outcome Measures

    Foot Health Status Questionnaire (FHSQ)
    It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
    Foot Health Status Questionnaire (FHSQ)
    It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
    Foot Health Status Questionnaire (FHSQ)
    It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Foot pain
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Step counts
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Global Rating Outcome Change (GROC)
    GRC scale asks that a person assess his or her current health status, recall that status at a previous time-point. The question is as below. With respect to you previous pain, how would you describe yourself now?
    Global Rating Outcome Change (GROC)
    GROC scale asks that a person assess his or her current health status, recall that status at a previous time-point. The question is as below. With respect to you previous pain, how would you describe yourself now?
    Patient Acceptable Symptom State (PASS)
    This is a single assessment self-reported tool. The question is as below. Taking into account your previous pain status, do you consider your foot health satisfactory?
    Patient Acceptable Symptom State (PASS)
    This is a single assessment self-reported tool. The question is as below. Taking into account your previous pain status, do you consider your foot health satisfactory?

    Secondary Outcome Measures

    International Physical Activity Questionnaire (IPAQ)
    It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
    International Physical Activity Questionnaire (IPAQ)
    It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
    International Physical Activity Questionnaire (IPAQ)
    It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
    Static and dynamic balance
    This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
    Static and dynamic balance
    This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
    Static and dynamic balance
    This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
    Muscles size of cross sectional area
    It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
    Muscles size of cross sectional area
    It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
    Muscles size of cross sectional area
    It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
    Muscle Strength
    Strength of the intrinsic muscles will be measured with a force dynamometer.
    Muscle Strength
    Strength of the intrinsic muscles will be measured with a force dynamometer.
    Muscle Strength
    Strength of the intrinsic muscles will be measured with a force dynamometer.

    Full Information

    First Posted
    February 6, 2023
    Last Updated
    May 17, 2023
    Sponsor
    University of South Florida
    Collaborators
    University of Hartford, National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05834491
    Brief Title
    A Novel Approach to Plantar Fasciitis in the Aging Population
    Acronym
    NAPA
    Official Title
    A Novel Approach to Plantar Fasciitis in the Aging Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 22, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2025 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of South Florida
    Collaborators
    University of Hartford, National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this study is to determine whether improving foot strength through foot exercises and minimal footwear can provide improved outcomes over the short and long term. The main research question it aims to answer is: Can the minimal footwear intervention be used to improve the health of aging adults with plantar fasciitis?? Participants will be randomized into 2 groups. One group will receive minimal shoes and foot strengthening and foot flexibility exercises. The other group will receive supportive shoes, foot orthotic device and foot flexibility exercises. Participants' step count will also be monitored. Researchers will compare pain and physical function between the minimal footwear (MF) and the foot orthotic (FO) groups at each of the follow-up sessions.
    Detailed Description
    Twenty five percent of older adults experience foot pain. Plantar fasciitis, a repetitive strain injury, is one of the most common causes of foot pain in this population. Ten percent of aging adults experience plantar fasciitis with 50% of the cases being disabling. Foot pain can lead to other problems such as reduced mobility, depression and prescription medication use, leading to a reduced quality of life. Foot pain has been related to foot weakness, reduced static and dynamic balance, and reduced walking speed in aging adults. The standard of care for plantar fasciitis is to brace the arch with foot orthoses and supportive shoes, thereby reducing the strain on the plantar fascia. However, arch support has been shown to be an ineffective long-term strategy for reducing foot pain, as well as leading to intrinsic foot muscle atrophy. As plantar fasciitis is associated with this atrophy, treating it with chronic arch support only increases the risk for recurrence. In fact, there is a 50% recurrence rate and a 45.6% risk of having plantar fasciitis 10 years after the onset of symptoms, and this risk increases with age. Minimal shoes are designed to allow the foot to function naturally, as if barefoot, which have already been successfully implemented in older adults for the treatment of knee osteoarthritis. Minimal shoes are highly flexible and lack the support of conventional footwear. This places a greater demand on the foot muscles, which promotes strengthening. Indeed, studies of gradual transitioning to walking in minimal shoes have demonstrated significant increases in intrinsic foot muscle size and strength. Stronger foot intrinsic foot muscles have been shown to reduce the strain on the plantar fascia with each step, thereby reducing the risk of developing plantar fasciitis. This is especially important in the older population who develop muscle weakness as they age. The overall objective of this study is to improve treatment interventions for plantar fasciitis in aging adults. The central hypothesis of this research is that strong intrinsic foot muscles will reduce the strain on the plantar fascia. This, in turn will result in resolution of pain, with less recurrence of plantar fasciitis than the standard of care. The investigators will test this hypothesis by comparing an intervention of stretching, foot orthoses and supportive shoes to one of foot stretching, strengthening and transition to minimal footwear. Training the foot of a patient with plantar fasciitis to function with less support is a significant paradigm shift from interventions aimed at passively supporting the foot. However, the investigators hypothesize that the dynamic stability of the foot muscles will be more effective than a static foot orthosis, that has been shown to promote foot weakening. The investigators will assess outcomes of foot pain, functional activities, and muscle strength, size and function at the 3- and 6-month follow-up, and the incidence of recurrence of plantar fasciitis at the 12 month time point.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fasciitis, Chronic
    Keywords
    minimal footwear, pain, function, strengthening

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    138 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimal Footwear (Vivobarefoot)
    Arm Type
    Experimental
    Arm Description
    The experimental intervention involves the combination of foot strengthening/stretching and minimal footwear to promote the foot strengthening beyond the exercise program to mitigate weakening from chronic support.
    Arm Title
    Supportive Footwear
    Arm Type
    Active Comparator
    Arm Description
    The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.
    Intervention Type
    Device
    Intervention Name(s)
    minimal shoes and foot strengthening and flexibility exercises
    Intervention Description
    Flexible shoes that do not provide support and exercises aimed at increasing the strength of plantar intrinsic and extrinsic foot muscles along with foot flexibility exercises aimed at increasing the range of motion of the foot and ankle
    Intervention Type
    Device
    Intervention Name(s)
    Supportive Footwear, foot orthotic device and foot flexibility exercises
    Intervention Description
    sturdy supportive shoes fitted with supportive foot orthotic devices and foot flexibility exercises aimed at increasing the range of motion of the foot and ankle
    Primary Outcome Measure Information:
    Title
    Foot Health Status Questionnaire (FHSQ)
    Description
    It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
    Time Frame
    Baseline
    Title
    Foot Health Status Questionnaire (FHSQ)
    Description
    It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
    Time Frame
    3 months
    Title
    Foot Health Status Questionnaire (FHSQ)
    Description
    It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
    Time Frame
    6 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    Baseline
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    1 month
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    2 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    3 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    4 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    5 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    6 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    7 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    8 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    9 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    10 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    11 months
    Title
    Foot pain
    Description
    Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; What is the worst your pain has been upon first step in the morning. What is the worst your pain has been during the day. Do you have any other foot or lower extremity pain that is limiting your walking?
    Time Frame
    12 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    Baseline
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    1 month
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    2 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    3 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    4 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    5 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    6 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    7 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    8 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    9 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    10 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    11 months
    Title
    Step counts
    Description
    Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
    Time Frame
    12 months
    Title
    Global Rating Outcome Change (GROC)
    Description
    GRC scale asks that a person assess his or her current health status, recall that status at a previous time-point. The question is as below. With respect to you previous pain, how would you describe yourself now?
    Time Frame
    3 months
    Title
    Global Rating Outcome Change (GROC)
    Description
    GROC scale asks that a person assess his or her current health status, recall that status at a previous time-point. The question is as below. With respect to you previous pain, how would you describe yourself now?
    Time Frame
    6 months
    Title
    Patient Acceptable Symptom State (PASS)
    Description
    This is a single assessment self-reported tool. The question is as below. Taking into account your previous pain status, do you consider your foot health satisfactory?
    Time Frame
    3 months
    Title
    Patient Acceptable Symptom State (PASS)
    Description
    This is a single assessment self-reported tool. The question is as below. Taking into account your previous pain status, do you consider your foot health satisfactory?
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    International Physical Activity Questionnaire (IPAQ)
    Description
    It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
    Time Frame
    Baseline
    Title
    International Physical Activity Questionnaire (IPAQ)
    Description
    It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
    Time Frame
    3 months
    Title
    International Physical Activity Questionnaire (IPAQ)
    Description
    It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
    Time Frame
    6 months
    Title
    Static and dynamic balance
    Description
    This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
    Time Frame
    Baseline
    Title
    Static and dynamic balance
    Description
    This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
    Time Frame
    3 months
    Title
    Static and dynamic balance
    Description
    This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
    Time Frame
    6 months
    Title
    Muscles size of cross sectional area
    Description
    It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
    Time Frame
    Baseline
    Title
    Muscles size of cross sectional area
    Description
    It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
    Time Frame
    3 months
    Title
    Muscles size of cross sectional area
    Description
    It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
    Time Frame
    6 months
    Title
    Muscle Strength
    Description
    Strength of the intrinsic muscles will be measured with a force dynamometer.
    Time Frame
    Baseline
    Title
    Muscle Strength
    Description
    Strength of the intrinsic muscles will be measured with a force dynamometer.
    Time Frame
    3 months
    Title
    Muscle Strength
    Description
    Strength of the intrinsic muscles will be measured with a force dynamometer.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    We will testing biomechanical changes which is depends on the gender that they were born. Therefore, eligibility will not be based on their self-representative identification
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1 Active plantar fasciitis for a minimum of 6 months. 2. Heel/arch pain on first step in the morning, 3. Heel/arch pain with prolonged standing (>15 min), 4. Heel/arch pain with prolonged walking (>15 min), 5. Be able to stand and walk for 10 minutes with little or no pain (<3/10 on a NRPS). Exclusion Criteria: Having systemic disease such as diabetes, gout, arthritis, neuropathy, surgical reconstructions Having a history of heel surgery or had a steroid injection for heel pain in the past 6 months. Used foot orthoses less than 3 months before start date of study. Having used minimal shoes at any time in the past. No special or vulnerable populations will be recruited.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Irene Davis, PhD
    Phone
    3025596433
    Email
    sdavis@usf.edu

    12. IPD Sharing Statement

    Learn more about this trial

    A Novel Approach to Plantar Fasciitis in the Aging Population

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