ArthralgiaNCT04830540
Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics
A study testing OOFOS Recovery Footwear in people with Arthralgia and Joint Stiffness, run by University of Massachusetts, Amherst at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthralgia, Joint Stiffness, Gait Mechanics
- What is being tested?
- OOFOS Recovery Footwear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18 - 35 kg/m2.
- Stiff or cleated footwear athlete on a competitive team.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Musculoskeletal & Orthopedic Biomechanics Laboratory/ University of Massachusetts Amherst
Amherst, Massachusetts, 01002
Katherine A Boyer, PhD, 413-545-1717, boyer@umass.edu
Katherine A Boyer, PhD
About this study
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.
Read the 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.
- Conditions
- Arthralgia, Joint Stiffness, Gait Mechanics
- Being tested
- OOFOS Recovery Footwear
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OOFOS Recovery FootwearDevice
The OOFOS shoes/ sandals are a commercially available footwear with a compliant, energy absorbing midsole material.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 |
| Intervention | Experimental | 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. Receives: Device: OOFOS Recovery Footwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calf Muscles Strength
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Measured: 2 - 3 hours on week 1
Calf Muscles Strength
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Measured: 2 - 3 hours on week 6.
Gait Mechanics
Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.
Measured: Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s
Gait Mechanics
Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.
Measured: Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s
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.
Measured: Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s
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.
Measured: Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s
Maximum Vertical Jump
Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.
Measured: 2 - 3 hours on week 1
Maximum Vertical Jump
Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.
Measured: 2 - 3 hours on week 6
Self-reported shoe comfort
Shoe wear and comfort log
Measured: Week 0, 5 minutes
Self-reported pain, and injury.
Injury and pain log
Measured: Week 0, 5 minutes
Self-reported shoe comfort
Shoe wear and comfort log
Measured: Week 2, 5 minutes
Self-reported pain, and injury.
Injury and pain log
Measured: Week 2, 5 minutes
Self-reported shoe comfort
Shoe wear and comfort log
Measured: Week 4, 5 minutes
Self-reported pain, and injury.
Injury and pain log
Measured: Week 4, 5 minutes
Self-reported shoe comfort
Shoe wear and comfort log
Measured: Week 6, 5 minutes
Self-reported pain, and injury.
Injury and pain log
Measured: Week 6, 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start8 Feb 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830540
- Sponsor's protocol ID
- 1826
- Status last verified
- Feb 2021
- First submitted
- 5 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics
- ClinicalTrials.gov ID
- NCT04830540
- Acronym / sponsor ID
- 1826
- Conditions
- Arthralgia, Joint Stiffness, Gait Mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 |
| Intervention | Experimental | Device: OOFOS Recovery FootwearIndividuals 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18 - 35 kg/m2.
- Stiff or cleated footwear athlete on a competitive team.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OOFOS Recovery FootwearThe OOFOS shoes/ sandals are a commercially available footwear with a compliant, energy absorbing midsole material. | Device | Intervention |
Primary outcome
Calf Muscles Strength
Time frame: 2 - 3 hours on week 1
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
Calf Muscles Strength
Time frame: 2 - 3 hours on week 6.
Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.
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.
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.
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.
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.
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.
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.
Self-reported shoe comfort
Time frame: Week 0, 5 minutes
Shoe wear and comfort log
Self-reported pain, and injury.
Time frame: Week 0, 5 minutes
Injury and pain log
Self-reported shoe comfort
Time frame: Week 2, 5 minutes
Shoe wear and comfort log
Self-reported pain, and injury.
Time frame: Week 2, 5 minutes
Injury and pain log
Self-reported shoe comfort
Time frame: Week 4, 5 minutes
Shoe wear and comfort log
Self-reported pain, and injury.
Time frame: Week 4, 5 minutes
Injury and pain log
Self-reported shoe comfort
Time frame: Week 6, 5 minutes
Shoe wear and comfort log
Self-reported pain, and injury.
Time frame: Week 6, 5 minutes
Injury and pain log
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Musculoskeletal & Orthopedic Biomechanics Laboratory/ University of Massachusetts Amherst
Amherst, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OOFOS Recovery Footwear in people with Arthralgia and Joint Stiffness, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calf Muscles Strength (time frame: 2 - 3 hours on week 1). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.