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Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain

Primary Purpose

Achilles Tendinopathy, Plantar Fascitis, Feet Pes Cavus

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
smart phone application
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Achilles Tendinopathy focused on measuring telerehabilitation, hind foot pain, plantar fasciitis, achilles tendinopathy, smart phone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pain in the heel and surrounding area
  • Have given consent to be a volunteer for participating to the study
  • 18 years and older
  • Ability to use a smartphone

Exclusion Criteria:

  • Having foot and ankle injury and surgery in the last three months
  • Have received physiotherapy or local injection before randomization
  • Having major pathologies during the rehabilitation program (severe heart and neuropsychiatric disorders, complicated diabetes mellitus)
  • Neoplastic formation in the foot-ankle region
  • Vision problem
  • Night pain

Sites / Locations

  • Elif Tuğçe ÇilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Plantar Fasciitis App Exercise Group

Achilles Tendinopathy App Exercise Group

Plantar Fasciitis Home Exercise Group

Achilles Tendinopathy Home Exercise Group

Plantar Fasciitis Conventional Physiotherapy Group

Achilles Tendinopathy Conventional Physiotherapy Group

Arm Description

Video simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks.

Video simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks.

Patients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks.

Patients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks.

In this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks.

In this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks.

Outcomes

Primary Outcome Measures

Feiss Line test
Feiss Line is an ankle examination procedure that tests for pes planus, flatfoot, fallen medial longitundinal arch.Patient should be standing with weight distributed evenly. The examiner uses a marker to mark the inferior apex of medial malleolus and medial surface of the base of the base of the 1st metatarsal. The examiner draws a line connecting the two points. The examiner locates the the navicular tuberosity and marks it.
the Range of Motion of the ankle
Physiotherapist will measure the Range of Motion of the ankle by using Goniometer
Visual Analog Scale - Pain Assesment
Visual Analogue Scale (VAS) was used to estimate the severity of participants' first step (morning time) and activity pain. It consists of a line, usually 100 mm long, whose ends are labeled as the extremes (no pain and worst pain imaginable); the rest of the line is blank.

Secondary Outcome Measures

Tampa Scale for Kinesiophobia
Tampa consists of 17 questions and is used in diseases associated with acute and chronic low back pain, fibromyalgia, and musculoskeletal injuries. The scale uses a 4-point Likert score (1 = Strongly disagree, 4 = Strongly agree). A total score is calculated after the reversal of items 4, 8, 12, and 16. The patients can have a total score of between 17-68. The higher the score indicates, the higher the kinesiophobia

Full Information

First Posted
June 2, 2020
Last Updated
June 9, 2020
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04423900
Brief Title
Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
Official Title
Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

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

5. Study Description

Brief Summary
This randomized controlled study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications. Additionally, to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.
Detailed Description
Foot pain is common in the general population, with prevalence estimates ranging from 17 to 30% . A systematic review concluded that nearly one-quarter of adults over age 45 experience frequent foot pain. Foot pain has been associated with poor balance, gait problems, the limitation of daily living activities, and health-related quality of life. It has been reported that at least two-thirds of individuals experience moderate functional daily life problems .The etiology of hindfoot pain is mostly associated with Achilles Tendinopathy and Plantar Fasciitis, which are prevalent, affecting millions of people each year . Most cases of hindfoot pain if not treated, they will get worse with time and resistant symptoms. This is why to get more information on prevalence and risk factors in the general population is necessary to organize health care planning and the extent of clinical need.An increase in the use of digital technology and smart phones globally with mobile applications provide an alternative solution to the planning of primary health care services. In the US, approximately 90% of adults have a mobile phone, and 58% of these prefer smart phones, while in Turkey, 98% of adults use mobile phones, and 77% of them are smart phones owners. The popularity of smart phones provides opportunities for reaching information and giving skills to users through applications. These applications offer new opportunities for collecting, evaluating, and monitoring health information and have portability, the flexibility of use, and a width of the access area.With the concept of this approaching (using digital technologies,) several systematic reviews have examined digital programs using for different health conditions/ pathologies (paralysis, lack of balance/stabilization, cardiac disorders, and joint / extremity). A great deal of physiotherapy interventions for hindfoot pain includes electrotherapy agents, 'hands-on' therapy, stretching, and strengthening exercises. The exercise programs are an essential part of rehabilitation programs for hindfoot pain, and patients who involved in this exercise program also need to get feedback by physiotherapist. For this reason, the digital technology-based applications are considered to be contributive for follow-up exercise regularly and detecting the changes and progression. Additionally, to the best of our knowledge, a smartphone application research involving hindfoot pathology with suggesting assessment methods and including exercise program is not available in the literature. Thereby, the study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications and to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Plantar Fascitis, Feet Pes Cavus, Feet Pes Planus (Flatfoot), Foot Diseases
Keywords
telerehabilitation, hind foot pain, plantar fasciitis, achilles tendinopathy, smart phone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One hundred twenty patients aged 18-75 years, diagnosed as Plantar fasciitis and Achilles Tendinopathy by an Orthopedic surgeon, will be included. Patients will be randomly divided into three groups according to inclusion criteria.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plantar Fasciitis App Exercise Group
Arm Type
Experimental
Arm Description
Video simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks.
Arm Title
Achilles Tendinopathy App Exercise Group
Arm Type
Experimental
Arm Description
Video simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks.
Arm Title
Plantar Fasciitis Home Exercise Group
Arm Type
Experimental
Arm Description
Patients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks.
Arm Title
Achilles Tendinopathy Home Exercise Group
Arm Type
Experimental
Arm Description
Patients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks.
Arm Title
Plantar Fasciitis Conventional Physiotherapy Group
Arm Type
Experimental
Arm Description
In this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks.
Arm Title
Achilles Tendinopathy Conventional Physiotherapy Group
Arm Type
Experimental
Arm Description
In this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks.
Intervention Type
Diagnostic Test
Intervention Name(s)
smart phone application
Intervention Description
Participants will be asked to provide information about their sociodemographic characteristics, chronic diseases, the history of the ankle injury, trauma, and surgery, the severity of the foot pain via using the mobile application.The app will be downloaded from the Google Play Store and available offline. Information from the patient will be stored in an SQLite database.The usability test will be carried out on the mobile application so that the latest releases contain clear, effective, loyal to the strategy, and easily understood messages by the intended audience and do not produce unwanted responses.Direct observation, individual interviews, and satisfaction surveys will be used to identify areas of improvement in a cross-sectional manner.Investigation of pes cavus, pes planus and ankle range of motion will be determined by image processing.All data can be analyzed and stored by Heel Analysis Systems established on an external server.The data will be transferred securely over HTTPS.
Primary Outcome Measure Information:
Title
Feiss Line test
Description
Feiss Line is an ankle examination procedure that tests for pes planus, flatfoot, fallen medial longitundinal arch.Patient should be standing with weight distributed evenly. The examiner uses a marker to mark the inferior apex of medial malleolus and medial surface of the base of the base of the 1st metatarsal. The examiner draws a line connecting the two points. The examiner locates the the navicular tuberosity and marks it.
Time Frame
8 weeks
Title
the Range of Motion of the ankle
Description
Physiotherapist will measure the Range of Motion of the ankle by using Goniometer
Time Frame
8 weeks
Title
Visual Analog Scale - Pain Assesment
Description
Visual Analogue Scale (VAS) was used to estimate the severity of participants' first step (morning time) and activity pain. It consists of a line, usually 100 mm long, whose ends are labeled as the extremes (no pain and worst pain imaginable); the rest of the line is blank.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia
Description
Tampa consists of 17 questions and is used in diseases associated with acute and chronic low back pain, fibromyalgia, and musculoskeletal injuries. The scale uses a 4-point Likert score (1 = Strongly disagree, 4 = Strongly agree). A total score is calculated after the reversal of items 4, 8, 12, and 16. The patients can have a total score of between 17-68. The higher the score indicates, the higher the kinesiophobia
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
The Victorian Institute of Sport Assessment-Achilles Questionnaire
Description
The VISA-A aims to evaluate the clinical severity of patients with chronic Achilles tendinopathy. It can be used to determine the patient's clinical severity and provide a guideline for treatments as well as for monitoring the effect of treatment. Robinson et al. designed the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, as a region-specific functional questionnaire, to assess the severity of AT.6 It contains eight questions that cover the three domains of pain (questions 1-3), function (questions 5-7) and activity (questions 7 and 8). Scores are summed to give a total out of 100. An asymptomatic person would score 100. It has proven to be a valid and reliable instrument to measure disability in cross-cultural studies conducted in Turkey
Time Frame
8 weeks
Title
Foot Function Index
Description
FFI assessed pain, activity restriction, and disability. The pain subscale, which includes nine items, measures foot pain related to a variety of conditions. Various functional activities depending on foot problems were determined by the disability subscale, which also includes nine items. Activity restrictions due to foot problems were assessed with an activity limitation subscale containing five items. Higher scores indicate more pain, disability, and limited activity. In our study, the patients were asked to mark each category with a score between 0 and 10 about their pain, activity restriction, and disability level. All the categorized scores were collected, and a total score was noted.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain in the heel and surrounding area Have given consent to be a volunteer for participating to the study 18 years and older Ability to use a smartphone Exclusion Criteria: Having foot and ankle injury and surgery in the last three months Have received physiotherapy or local injection before randomization Having major pathologies during the rehabilitation program (severe heart and neuropsychiatric disorders, complicated diabetes mellitus) Neoplastic formation in the foot-ankle region Vision problem Night pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Tuğçe Çil, M.S.c
Phone
05544811092
Email
tugce.cill@gmail.com
Facility Information:
Facility Name
Elif Tuğçe Çil
City
İstanbul
State/Province
Europe
ZIP/Postal Code
34755
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ELİF TUĞÇE ÇİL, M.S.c
Phone
05544811092
Email
tugce.cill@gmail.com
First Name & Middle Initial & Last Name & Degree
Feryal Subaşı, Professor
First Name & Middle Initial & Last Name & Degree
Uğur Şaylı, Professor
First Name & Middle Initial & Last Name & Degree
Tacha Serif, Asisstant Prof.
First Name & Middle Initial & Last Name & Degree
Gülşah Gökhan Gökçek, Engineer

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain

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