Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04830540
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Amherst

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.


Condition or disease Intervention/treatment Phase
Arthralgia Joint Stiffness Gait Mechanics Device: OOFOS Recovery Footwear Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Arm Intervention/treatment
No Intervention: Control
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
Experimental: Intervention
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.
Device: OOFOS Recovery Footwear
The OOFOS shoes/ sandals are a commercially available footwear with a compliant, energy absorbing midsole material.




Primary Outcome Measures :
  1. Calf Muscles Strength [ Time Frame: 2 - 3 hours on week 1 ]
    Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.

  2. Calf Muscles Strength [ Time Frame: 2 - 3 hours on week 6. ]
    Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.

  3. Gait Mechanics [ Time Frame: Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s ]
    Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.

  4. Gait Mechanics [ Time Frame: Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s ]
    Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.

  5. Muscle EMG activity [ Time Frame: Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s ]
    Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.

  6. Muscle EMG activity [ Time Frame: Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s ]
    Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.

  7. Maximum Vertical Jump [ Time Frame: 2 - 3 hours on week 1 ]
    Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.

  8. Maximum Vertical Jump [ Time Frame: 2 - 3 hours on week 6 ]
    Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.

  9. Self-reported shoe comfort [ Time Frame: Week 0, 5 minutes ]
    Shoe wear and comfort log

  10. Self-reported pain, and injury. [ Time Frame: Week 0, 5 minutes ]
    Injury and pain log

  11. Self-reported shoe comfort [ Time Frame: Week 2, 5 minutes ]
    Shoe wear and comfort log

  12. Self-reported pain, and injury. [ Time Frame: Week 2, 5 minutes ]
    Injury and pain log

  13. Self-reported shoe comfort [ Time Frame: Week 4, 5 minutes ]
    Shoe wear and comfort log

  14. Self-reported pain, and injury. [ Time Frame: Week 4, 5 minutes ]
    Injury and pain log

  15. Self-reported shoe comfort [ Time Frame: Week 6, 5 minutes ]
    Shoe wear and comfort log

  16. Self-reported pain, and injury. [ Time Frame: Week 6, 5 minutes ]
    Injury and pain log



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830540


Locations
Layout table for location information
United States, Massachusetts
Musculoskeletal & Orthopedic Biomechanics Laboratory/ University of Massachusetts Amherst Recruiting
Amherst, Massachusetts, United States, 01002
Contact: Katherine A Boyer, PhD    413-545-1717    boyer@umass.edu   
Principal Investigator: Katherine A Boyer, PhD         
Sub-Investigator: Ericber Jimenez Francisco, PhD         
Sub-Investigator: Skylar C Holmes, MS         
Sub-Investigator: Kali E Shamaly, BS         
Sub-Investigator: Ramzi M Majaj, MS         
Sponsors and Collaborators
University of Massachusetts, Amherst
Layout table for additonal information
Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT04830540    
Other Study ID Numbers: 1826
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations