Spinal Cord InjuryNCT03930056
C-Brace II Spinal Cord Injury
A study testing C-Brace II and Traditional Care KAFO intervention in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional care knee-ankle-foot-orthosis (KAFO) models following discharge from inpatient rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- C-Brace II and Traditional Care KAFO intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to Nov 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be within 3-24 months post spinal cord injury diagnosis
- 18-80 years
- Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
- Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
Who cannot join
- Unstable neurological, cardiovascular, or cancer diagnoses.
- Cognitive impairments that limit study participation
- In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II):
- Body weight over 275 lbs
- Flexion contracture in the knee and/or hip joint in excess of 10 degrees
- Non-correctable knee varus/valgus in excess of 10 degrees
Show all 10Show fewer
- Moderate to severe spasticity
- Leg length discrepancy in excess of 6" (15.24 cm)
- Inability to stabilize the trunk with or without assistive devices (crutches, cane, etc.)
- Inability to successfully use C-Brace trial tool in advancement of leg/s.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micro-Processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Usage in a Spinal Cord Injury (SCI) Population Compared to Traditional Rehabilitation Methods: Determining Functional Outcome Differences of Recovery
A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional care knee-ankle-foot-orthosis (KAFO) models following discharge from inpatient rehabilitation.
- Conditions
- Spinal Cord Injury
- Being tested
- C-Brace II, Traditional Care KAFO intervention
- Keywords
- Orthotic, C-Brace
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Brace IIDevice
Participant will complete 3-6 orthoses sessions to complete clinical evaluations and fittings conducted by certified orthotists.
Participant will receive 10-20, one hour training sessions over 1-2 months in the lab. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention.
Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row.
Participant will take the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
Traditional Care KAFO interventionDevice
Participant will continue with use of their own KAFO. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab, if Patient is not already receiving care in a therapy setting. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will continue with the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
| Study group | Role | What they receive |
|---|---|---|
| C-Brace II Group | Experimental | Subjects will be assigned a C-Brace II orthotic for use. Receives: Device: C-Brace II |
| Traditional Group | Active comparator | Subjects will continue with their own KAFO (non C-Brace II) use. Receives: Device: Traditional Care KAFO intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test (6MWT)
The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.
Measured: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.
Secondary outcomes (9)
Muscle Strength (manual muscle test)
Muscle strength will be assessed by a trained clinical researcher
Measured: Change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.
Passive and Active Range of Motion of Lower Extremity joints
Measured: Change from baseline in range of motion after using device at 3, 6, and 12 month follow-up.
Modified Ashworth Scale
A scale used to measure the amount of tone in individuals with neurologic diagnoses. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
Measured: Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up.
10 Meter Walk Test (10MWT)
This test will examine the patient's gait speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10 meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundred of a second (ex: 2.15 sec). The test will be recorded 6 times: 3 times at the patient's self-selected speed, and 3 times at the patient's quickest, yet safest speed. The average of each of the 3 times will be recorded. Adequate rest in between trials will be given.
Measured: Change from baseline in gait speed after using device at 3, 6, and 12 month follow-up.
Walking Index for Spinal Cord Injury (WISCI II)
A rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces, and physical assistance of one or more persons.
Measured: Change from baseline in rank score after using device at 3, 6, and 12 month follow-up.
Functional Gait Assessment (FGA)
The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.
Measured: Change from baseline in FGA score after using device at 3, 6, and 12 month follow-up.
Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item scale designed to measure balance in adults in a clinical setting. When scoring, the lowest response category that applies should be recorded. In each item, points should be deducted if the time or distance requirements are not met, the subject's performance requires supervision, or the subject requires assistance from support or examiner.
Measured: Change from baseline in Berg Balance score after using device at 3, 6, and 12 month follow-up.
Timed Up and Go test (TUG)
A test which times the ability of a patient to stand up from a standard chair with arm rests, walk 3 meters forward, turn around, walk 3 meters back to the chair, and sit back down in the chair.
Measured: Change from baseline in TUG score after using device at 3, 6, and 12 month follow-up.
Gaitrite data capture
The Gaitrite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The Gaitrite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The Gaitrite electronic walkway for the study shall be a minimum of 14 feet long. The Gaitrite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the Gaitrite electronic walkway.
Measured: Change from baseline in gait parameters after using device at 3, 6, and 12 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start16 Apr 2019
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930056
- Sponsor's protocol ID
- STU00208781
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2019
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-Processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Usage in a Spinal Cord Injury (SCI) Population Compared to Traditional Rehabilitation Methods: Determining Functional Outcome Differences of Recovery
- ClinicalTrials.gov ID
- NCT03930056
- Acronym / sponsor ID
- STU00208781
- Conditions
- Spinal Cord Injury
- Keywords
- Orthotic, C-Brace
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Apr 2019 (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.
A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional care knee-ankle-foot-orthosis (KAFO) models following discharge from inpatient rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Brace II Group | Experimental | Device: C-Brace IISubjects will be assigned a C-Brace II orthotic for use. |
| Traditional Group | Active comparator | Device: Traditional Care KAFO interventionSubjects will continue with their own KAFO (non C-Brace II) use. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be within 3-24 months post spinal cord injury diagnosis
- 18-80 years
- Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
- Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
Key exclusion criteria (10 listed)
- Unstable neurological, cardiovascular, or cancer diagnoses.
- Cognitive impairments that limit study participation
- In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II):
- Body weight over 275 lbs
- Flexion contracture in the knee and/or hip joint in excess of 10 degrees
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 |
|---|---|---|
| C-Brace IIParticipant will complete 3-6 orthoses sessions to complete clinical evaluations and fittings conducted by certified orthotists. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will take the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing. | Device | C-Brace II Group |
| Traditional Care KAFO interventionParticipant will continue with use of their own KAFO. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab, if Patient is not already receiving care in a therapy setting. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will continue with the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing. | Device | Traditional Group |
Primary outcome
Six Minute Walk Test (6MWT)
Time frame: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.
The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.
9 secondary outcomes
Muscle Strength (manual muscle test)
Time frame: Change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.
Passive and Active Range of Motion of Lower Extremity joints
Time frame: Change from baseline in range of motion after using device at 3, 6, and 12 month follow-up.
Modified Ashworth Scale
Time frame: Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up.
10 Meter Walk Test (10MWT)
Time frame: Change from baseline in gait speed after using device at 3, 6, and 12 month follow-up.
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Change from baseline in rank score after using device at 3, 6, and 12 month follow-up.
Functional Gait Assessment (FGA)
Time frame: Change from baseline in FGA score after using device at 3, 6, and 12 month follow-up.
Berg Balance Scale (BBS)
Time frame: Change from baseline in Berg Balance score after using device at 3, 6, and 12 month follow-up.
Timed Up and Go test (TUG)
Time frame: Change from baseline in TUG score after using device at 3, 6, and 12 month follow-up.
Gaitrite data capture
Time frame: Change from baseline in gait parameters after using device at 3, 6, and 12 month follow-up.
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 24 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Brace II and Traditional Care KAFO intervention in people with Spinal Cord Injury, 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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walk Test (6MWT) (time frame: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.). 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 24 Dec 2025.