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Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics

Primary Purpose

Arthralgia, Joint Stiffness, Gait Mechanics

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OOFOS Recovery Footwear
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arthralgia

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 18 - 35 kg/m2.
  • Stiff or cleated footwear athlete on a competitive team.

Exclusion Criteria:

  • Current injury that required absence from one or more practices in the last 3 weeks of regular team practice.
  • Orthotic or other shoe insert used outside of athletic training times.

Sites / Locations

  • Musculoskeletal & Orthopedic Biomechanics Laboratory/ University of Massachusetts AmherstRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Participants assigned to the control group will be asked to continue wearing their typical shoes and to complete every two weeks the footwear and injury log provided

Individuals assigned to the intervention group will be provided with 2 styles of the OOFOS recovery shoes, and will be asked to wear the OOFOS slide, sandal and/or closed toe shoes as their primary footwear outside training and competition for the 6 weeks between study visits. Intervention participants will also be asked to complete a daily shoe wear log and a shoe comfort assessment survey every other week.

Outcomes

Primary Outcome Measures

Calf Muscles Strength
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Calf Muscles Strength
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Gait Mechanics
Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.
Gait Mechanics
Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.
Muscle EMG activity
Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.
Muscle EMG activity
Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.
Maximum Vertical Jump
Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.
Maximum Vertical Jump
Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.
Self-reported shoe comfort
Shoe wear and comfort log
Self-reported pain, and injury.
Injury and pain log
Self-reported shoe comfort
Shoe wear and comfort log
Self-reported pain, and injury.
Injury and pain log
Self-reported shoe comfort
Shoe wear and comfort log
Self-reported pain, and injury.
Injury and pain log
Self-reported shoe comfort
Shoe wear and comfort log
Self-reported pain, and injury.
Injury and pain log

Secondary Outcome Measures

Full Information

First Posted
March 5, 2021
Last Updated
April 1, 2021
Sponsor
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT04830540
Brief Title
Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics
Official Title
Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Amherst

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 understand the impact of wearing shoes with a compliant, energy absorbing midsole material, outside of athletic training sessions on the mechanics of movement, performance, and perceived joint pain and stiffness. Advances in material science have led to a wider range of cushioning system material properties and mid and outsole geometries in footwear. While there are many marketing claims about the potential health benefits of this new class of footwear these have not yet been investigated in well-designed scientific studies. It is hypothesized that the intervention shoe as compared to the control will reduce self-reported joint pain and stiffness, improve ankle plantarflexion function and increase intersegmental foot motion during walking.
Detailed Description
Participants will be asked to make 2 visits, 6 weeks apart, to the Umass Biomechanics Lab in the Totman Building at UMass Amherst for gait analysis and biomechanical performance testing. At the first study visit, participants will be randomly assigned to one of two groups. Participants assigned to the control group will be asked to continue wearing their typical shoes and to complete every two weeks the footwear and injury log provided. Individuals assigned to the intervention group will be provided with 2 styles of the OOFOS recovery shoes, and will be asked to wear the OOFOS slide, sandal and/or closed toe shoes as their primary footwear outside training and competition for the 6 weeks between study visits. Intervention participants will also be asked to complete a daily shoe wear log and a shoe comfort assessment survey every other week. At each study visit, subjects will be asked to read and sign an Informed Consent Form, and will also be asked questions about their health, exercise, and injury history. To prepare for the data collection, participants will be asked to change into a pair of shorts and tight shirt that will be provided. Anatomic measurements will then be made with a measuring tape, and ankle flexibility will be assessed by manually moving the participant's ankle into the most flexed and most extended position. Reflective markers will then be placed on subject's feet/shoes, legs, thighs, hips, shoulders, and arms to record 3-D limb kinematics. To place the markers, we will put little circles of double-sided tape on skin or clothing, with reflective balls on the outer side. The position of the reflective markers will be recorded by high-speed infrared cameras surrounding the data collection space. Subjects will also be instrumented with electromyography (EMG) sensors on the skin over muscles of the leg, to measure the activity of those muscles. Before placing the EMG sensors, a small patch of skin will be shaved to ensure the sensor stays in place and captures the signals needed. Once markers have been placed, subjects will stand in the data collection space to record a standing calibration trial of the markers. The standing calibration trial will be used to create a computer model on which data analysis will be performed. Subjects will then walk on a long walkway with the cameras surrounding it at a both self-selected and a set speed of 1.4 m/s. This will be repeated several times until at least 5 successful trials have been recorded. A successful trial means that the walking speed varies by no more than 5 % from the previous trial. Subjects will perform the walking trials barefoot and in the OOFOS sandal and closed toe shoes. Following the gait analysis described above, calf muscle strength will be assessed using a dynamometer. The subject will sit with the leg, hips, and torso securely strapped to prevent unwanted movement. Subjects will then preform isometric and dynamic contractions; enough repetitions will be allowed to facilitate learning of the technique required. The final test will be a maximum vertical jump height test. Subjects will stand in the middle of the motion capture area and jump as high as they can from a standing position. When the above procedures are completed, the research staff will open the intervention assignment envelope that will determine if you are assigned to the intervention or control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, Joint Stiffness, Gait Mechanics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will be asked to continue wearing their typical shoes and to complete every two weeks the footwear and injury log provided
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Individuals assigned to the intervention group will be provided with 2 styles of the OOFOS recovery shoes, and will be asked to wear the OOFOS slide, sandal and/or closed toe shoes as their primary footwear outside training and competition for the 6 weeks between study visits. Intervention participants will also be asked to complete a daily shoe wear log and a shoe comfort assessment survey every other week.
Intervention Type
Device
Intervention Name(s)
OOFOS Recovery Footwear
Intervention Description
The OOFOS shoes/ sandals are a commercially available footwear with a compliant, energy absorbing midsole material.
Primary Outcome Measure Information:
Title
Calf Muscles Strength
Description
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Time Frame
2 - 3 hours on week 1
Title
Calf Muscles Strength
Description
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Time Frame
2 - 3 hours on week 6.
Title
Gait Mechanics
Description
Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.
Time Frame
Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s
Title
Gait Mechanics
Description
Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.
Time Frame
Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s
Title
Muscle EMG activity
Description
Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.
Time Frame
Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s
Title
Muscle EMG activity
Description
Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.
Time Frame
Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s
Title
Maximum Vertical Jump
Description
Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.
Time Frame
2 - 3 hours on week 1
Title
Maximum Vertical Jump
Description
Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.
Time Frame
2 - 3 hours on week 6
Title
Self-reported shoe comfort
Description
Shoe wear and comfort log
Time Frame
Week 0, 5 minutes
Title
Self-reported pain, and injury.
Description
Injury and pain log
Time Frame
Week 0, 5 minutes
Title
Self-reported shoe comfort
Description
Shoe wear and comfort log
Time Frame
Week 2, 5 minutes
Title
Self-reported pain, and injury.
Description
Injury and pain log
Time Frame
Week 2, 5 minutes
Title
Self-reported shoe comfort
Description
Shoe wear and comfort log
Time Frame
Week 4, 5 minutes
Title
Self-reported pain, and injury.
Description
Injury and pain log
Time Frame
Week 4, 5 minutes
Title
Self-reported shoe comfort
Description
Shoe wear and comfort log
Time Frame
Week 6, 5 minutes
Title
Self-reported pain, and injury.
Description
Injury and pain log
Time Frame
Week 6, 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 18 - 35 kg/m2. Stiff or cleated footwear athlete on a competitive team. Exclusion Criteria: Current injury that required absence from one or more practices in the last 3 weeks of regular team practice. Orthotic or other shoe insert used outside of athletic training times.
Facility Information:
Facility Name
Musculoskeletal & Orthopedic Biomechanics Laboratory/ University of Massachusetts Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine A Boyer, PhD
Phone
413-545-1717
Email
boyer@umass.edu
First Name & Middle Initial & Last Name & Degree
Katherine A Boyer, PhD
First Name & Middle Initial & Last Name & Degree
Ericber Jimenez Francisco, PhD
First Name & Middle Initial & Last Name & Degree
Skylar C Holmes, MS
First Name & Middle Initial & Last Name & Degree
Kali E Shamaly, BS
First Name & Middle Initial & Last Name & Degree
Ramzi M Majaj, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics

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