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Official title Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
ClinicalTrials.gov ID: NCT06127264
What this study is testing
- What it's testing
- The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Group 1 - Able Bodied Participants
- Between the ages of 18 and 65
- Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders...
- Able to hop without pain
- Able to perform a full squat without pain
You likely can't join if
- Diagnosed with a moderate or severe brain injury
- Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Injuries that would limit performance in this study
- Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary...
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- Require use of an assistive device
See the full eligibility criteria
- Group 1 - Able Bodied Participants
- Between the ages of 18 and 65
- Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last...
- Able to hop without pain
- Able to perform a full squat without pain
- Ability to read and write in English and provide written informed consent
- Ability to fit in a generic sized CDO
- Diagnosed with a moderate or severe brain injury
- Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Injuries that would limit performance in this study
- Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- Require use of an assistive device
- Unhealed wounds (cuts/abrasions) that would prevent AFO use
- BMI \> 40
- Pregnancy Group 2 - AFO Users without Peripheral Neuropathy Inclusion Criteria:
- Between the ages of 18 and 90
- Use an AFO(s) for daily activities
- The AFO(s) proximal cuff is compatible with loadpad sensors
- Have used their AFO(s) for a minimum of 2 weeks
- Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
- Ability to read and write in English and provide written informed consent Exclusion Criteria
- Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
- Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
- Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- BMI \> 40
- Pregnancy Group 3 - AFO Users with Peripheral Neuropathy Inclusion Criteria:
- Between the ages of 18 and 90
- Use an AFO(s) for daily activities
- The AFO(s) proximal cuff is compatible with loadpad sensors
- Have used their AFO(s) for a minimum of 2 weeks
- Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
- Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
- Ability to read and write in English and provide written informed consent Exclusion Criteria
- Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
- Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
- Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- BMI \> 40
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.