Cerebrovascular AccidentNCT05644522
Nomad P-KAFO Study
A study testing Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) in people with Cerebrovascular Accident and Post-polio Syndrome, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries
- What is being tested?
- Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma
- Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
- Willing to wear and charge an activity monitor for three-months home trials.
Who cannot join
- Flexion contracture in the knee and/or hip joint in excess of 15 degrees
- Non-correctable knee varus/valgus in excess of 15 degrees
- Severe spasticity
- Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Arun Jayaraman, PhD, ajayaraman@sralab.org
About this study
Official title: Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use.
Participants will:
- Wear a sensor that records everyday activities and mobility.
- Perform measures of mobility and different activities of participation using their own brace.
- Perform measures of mobility and different activities of participation using the Nomad powered KAFO
- Conditions
- Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophy, Paralysis
- Being tested
- Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
- Medical subject headings
- Stroke, Postpoliomyelitis Syndrome, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophies, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)Device
The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A receives the intervention Nomad KAFO first; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Receives: Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) |
| Group B | Active comparator | Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Receives: Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 Meter Walk Test speed
A test to measure the change of speed of both self selected and fastest walking speeds
Measured: Baseline, Post 3-month home trials with each device
Secondary outcomes (16)
Six Minute Walk Test
A test to measure how much distance is traveled over the course of 6 minutes.
Measured: Baseline, Post 3-month home trials with each device
Berg Balance Test
A test of standing balance
Measured: Baseline, Post 3-month home trials with each device
Functional Gait Assessment
A test of postural stability during walking tasks
Measured: Baseline, Post 3-month home trials with each device
Hill Assessment Index
Used to assess different gait patterns during ascent or descent of slopes
Measured: Baseline, Post 3-month home trials with each device
Stair Assessment Index
Used to assess functional abilities during ascent and descent of stairs
Measured: Baseline, Post 3-month home trials with each device
Timed Up and Go
A functional mobility test to measure how long it takes to rise from a chair, walk 3 meters, turn around, and return back to a sitting position in the chair.
Measured: Baseline, Post 3-month home trials with each device
Activities Specific Balance Confidence Scale
A self-report questionnaire designed to measure fear of falling across 16 items.
Measured: Baseline, Post 3-month home trials with each device
Modified Falls Efficacy Scale
A self-report questionnaire designed to measure fear of falling across 14 items.
Measured: Baseline, Post 3-month home trials with each device
Orthotics and Prosthetics User Survey
A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services.
Measured: Baseline, Post 3-month home trials with each device
World Health Organization Quality of Life
A self-report questionnaire that measures an individual's perceived quality of life.
Measured: Baseline, Post 3-month home trials with each device
EQ5D-5L
A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, Post 3-month home trials with each device
Numeric Pain Rating Scale
A measure of perceived pain intensity
Measured: Baseline, Post 3-month home trials with each device, and as needed throughout course of study.
Borg Rate of Perceived Exertion
A measure of perceived exertion during an activity
Measured: Baseline, Post 3-month home trials with each device, and as needed throughout course of study
Manual Muscle Test
A rating of overall gross muscle strength
Measured: Screening, Baseline, Post 3-month home trials with each device
Range of Motion (both passive and active)
A measurement of overall joint mobility of both lower extremities
Measured: Screening, Baseline, Post 3-month home trials with each device
Six Minute Push Test
A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes.
Measured: Baseline, Post 3-month home trials with each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644522
- Sponsor's protocol ID
- STU00217395
- Status last verified
- May 2026
- First submitted
- 28 Nov 2022
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
- ClinicalTrials.gov ID
- NCT05644522
- Acronym / sponsor ID
- STU00217395
- Conditions
- Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophy, Paralysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2022 (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 clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use.
Participants will:
- Wear a sensor that records everyday activities and mobility.
- Perform measures of mobility and different activities of participation using their own brace.
- Perform measures of mobility and different activities of participation using the Nomad powered KAFO
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)Group A receives the intervention Nomad KAFO first; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. |
| Group B | Active comparator | Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma
- Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
- Willing to wear and charge an activity monitor for three-months home trials.
Key exclusion criteria (4 listed)
- Flexion contracture in the knee and/or hip joint in excess of 15 degrees
- Non-correctable knee varus/valgus in excess of 15 degrees
- Severe spasticity
- Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
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 |
|---|---|---|
| Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque. | Device | Group A, Group B |
Primary outcome
Change in 10 Meter Walk Test speed
Time frame: Baseline, Post 3-month home trials with each device
A test to measure the change of speed of both self selected and fastest walking speeds
16 secondary outcomes
Six Minute Walk Test
Time frame: Baseline, Post 3-month home trials with each device
Berg Balance Test
Time frame: Baseline, Post 3-month home trials with each device
Functional Gait Assessment
Time frame: Baseline, Post 3-month home trials with each device
Hill Assessment Index
Time frame: Baseline, Post 3-month home trials with each device
Stair Assessment Index
Time frame: Baseline, Post 3-month home trials with each device
Timed Up and Go
Time frame: Baseline, Post 3-month home trials with each device
Activities Specific Balance Confidence Scale
Time frame: Baseline, Post 3-month home trials with each device
Modified Falls Efficacy Scale
Time frame: Baseline, Post 3-month home trials with each device
Orthotics and Prosthetics User Survey
Time frame: Baseline, Post 3-month home trials with each device
World Health Organization Quality of Life
Time frame: Baseline, Post 3-month home trials with each device
EQ5D-5L
Time frame: Baseline, Post 3-month home trials with each device
Numeric Pain Rating Scale
Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study.
Borg Rate of Perceived Exertion
Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study
Manual Muscle Test
Time frame: Screening, Baseline, Post 3-month home trials with each device
Range of Motion (both passive and active)
Time frame: Screening, Baseline, Post 3-month home trials with each device
Six Minute Push Test
Time frame: Baseline, Post 3-month home trials with each device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) in people with Cerebrovascular Accident and Post-polio Syndrome, run by Shirley Ryan AbilityLab 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arun Jayaraman, PhD (312-238-6875, ajayaraman@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 Meter Walk Test speed (time frame: Baseline, Post 3-month home trials with each device). 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 11 May 2026.