Spinal Cord InjuriesNCT02089880
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
A study testing C-brace in people with Spinal Cord Injuries and Poliomyelitis, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Poliomyelitis, Post-polio Syndrome
- What is being tested?
- C-brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2025
- 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
- Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
- Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
- Age 18 - 80 years.
- Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
- Cognitive ability to understand and the willingness to sign a written informed consent.
- Subjects must be able to demonstrate the ability to turn the global positioning sensor (GPS) and Actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
Who cannot join
- Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
- Body weight >275 pounds.
- Unstable neurological or cardiovascular/pulmonary disease, cancer.
- Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
- Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Micro-processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Versus Stance-control Knee-Ankle-Foot Orthosis (SCO): Functional Outcomes in Individuals With Lower Extremity Impairment
The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.
- Conditions
- Spinal Cord Injuries, Poliomyelitis, Post-polio Syndrome, Arthritis, Lower Motor Neurone Lesion
- Being tested
- C-brace, Stance control orthosis
- Medical subject headings
- Spinal Cord Injuries, Poliomyelitis, Postpoliomyelitis Syndrome, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-braceDevice
Also called C-Brace by Ottobock
The participant will receive 6 sessions of training over a one month period in using the C-brace in all levels of functional gait. The participant will then continue use of the C-brace for one month following training. The C-Brace from Otto Bock is an orthosis that controls throughout stance and swing phases of gait with a micro-processor (MP) controlled knee.
Stance control orthosisDevice
The participant will receive 6 sessions of training over a one month period in using his current stance control knee-ankle-foot orthosis (SCO) in all levels of functional gait. The participant will then continue use of the SCO for one month following training. The SCO controls the knee by maintaining it straight and extended during the stance phase of gait.
| Study group | Role | What they receive |
|---|---|---|
| C-brace then stance control orthosis | Experimental | Not described Receives: Device: C-brace; Device: Stance control orthosis |
| Stance control orthosis then C-brace | Experimental | Not described Receives: Device: C-brace; Device: Stance control orthosis |
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 using device 1 at 8 weeks and using device 2 at 16 weeks.
Secondary outcomes (10)
Muscle strength
Muscle strength with be assessed using a hand held dynamometer for muscle strength testing of the lower limb.
Measured: Change from baseline in muscle strength after device 1 use at 8 weeks and after device 2 use at 16 weeks.
Passive and active range of motion
Measured: Change from baseline in range of motion after device 1 use at 8 weeks and after device 2 use at 16 weeks.
10 meter walk test
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 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 hundredth of a second (ex: 2.15 sec). The test will be recorded 2 times, with adequate rest in between. The average of the 2 times should be recorded.
Measured: Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks.
Hill Assessment Index
The Hill Assessment Index is a 12 point ordinal scale used to assess different gait patterns during ascent or descent of slopes. It was developed to detect differences in function with different knee units for transfemoral prosthetics.
Measured: Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks.
Stair Assessment Index
The Stair Assessment Index is a 14 point ordinal scale originally used to assess functional abilities during ascent and descent of stairs.
Measured: Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks.
Cross Walk Blinking Signal Test
The cross walk blinking signal test will measure how long it takes a participant to cross a designated street. The street that is designated for the street is 2 lanes and has ramps from the sidewalk to the street. The distance measured will be from the end of the ramp or edge of the curb on either side of the street.
Measured: Change from baseline in the Cross Walk Blinking Signal Test using device 1 at 8 weeks and using device 2 at 16 weeks.
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 using device 1 at 8 weeks and using device 2 at 16 weeks.
Berg Balance Scale
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 Scale score using device 1 at 8 weeks and using device 2 at 16 weeks.
Functional Gait Assessment
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 Functional Gait Assessment scores using device 1 at 8 weeks and using device 2 at 16 weeks.
5 times sit to stand test
The 5 Time Sit to Stand Test is a measure of functional lower limb strength during transitional movement. The individual sits in a standard height chair (43-45 cm) and is instructed to stand up and sit down 5 times as quickly as possible.
Measured: Change from baseline in 5 times sit to stand test using device 1 at 8 weeks and using device 2 at 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02089880
- Sponsor's protocol ID
- 85951
- Status last verified
- Apr 2025
- First submitted
- 26 Feb 2014
- Last updated
- 1 May 2025
- Results posted
- No
Publications
Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, Semik P, Heinemann AW, Jayaraman A. Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):233-244. doi: 10.1016/j.apmr.2020.08.013. Epub 2020 Sep 22.
PubMed 32976844
Study at a glance
From the registry record, last updated by the sponsor on 1 May 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) Versus Stance-control Knee-Ankle-Foot Orthosis (SCO): Functional Outcomes in Individuals With Lower Extremity Impairment
- ClinicalTrials.gov ID
- NCT02089880
- Acronym / sponsor ID
- 85951
- Conditions
- Spinal Cord Injuries, Poliomyelitis, Post-polio Syndrome, Arthritis, Lower Motor Neurone Lesion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- 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 study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-brace then stance control orthosis | Experimental | Device: C-brace, Device: Stance control orthosis |
| Stance control orthosis then C-brace | Experimental | Device: C-brace, Device: Stance control orthosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
- Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
- Age 18 - 80 years.
- Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
- Cognitive ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (5 listed)
- Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
- Body weight >275 pounds.
- Unstable neurological or cardiovascular/pulmonary disease, cancer.
- Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
- Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
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-braceAlso: C-Brace by OttobockThe participant will receive 6 sessions of training over a one month period in using the C-brace in all levels of functional gait. The participant will then continue use of the C-brace for one month following training. The C-Brace from Otto Bock is an orthosis that controls throughout stance and swing phases of gait with a micro-processor (MP) controlled knee. | Device | C-brace then stance control orthosis, Stance control orthosis then C-brace |
| Stance control orthosisThe participant will receive 6 sessions of training over a one month period in using his current stance control knee-ankle-foot orthosis (SCO) in all levels of functional gait. The participant will then continue use of the SCO for one month following training. The SCO controls the knee by maintaining it straight and extended during the stance phase of gait. | Device | C-brace then stance control orthosis, Stance control orthosis then C-brace |
Primary outcome
Six minute walk test (6MWT)
Time frame: Change from baseline in 6MWT using device 1 at 8 weeks and using device 2 at 16 weeks.
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.
10 secondary outcomes
Muscle strength
Time frame: Change from baseline in muscle strength after device 1 use at 8 weeks and after device 2 use at 16 weeks.
Passive and active range of motion
Time frame: Change from baseline in range of motion after device 1 use at 8 weeks and after device 2 use at 16 weeks.
10 meter walk test
Time frame: Change from baseline in gait speed using device 1 at 8 weeks and using device 2 at 16 weeks.
Hill Assessment Index
Time frame: Change from baseline in hill descent using device 1 at 8 weeks and using device 2 at 16 weeks.
Stair Assessment Index
Time frame: Change from baseline in stair descent using device 1 at 8 weeks and using device 2 at 16 weeks.
Cross Walk Blinking Signal Test
Time frame: Change from baseline in the Cross Walk Blinking Signal Test using device 1 at 8 weeks and using device 2 at 16 weeks.
GAITRite Data Capture
Time frame: Change from baseline in gait parameters using device 1 at 8 weeks and using device 2 at 16 weeks.
Berg Balance Scale
Time frame: Change from baseline in Berg Balance Scale score using device 1 at 8 weeks and using device 2 at 16 weeks.
Functional Gait Assessment
Time frame: Change from baseline in Functional Gait Assessment scores using device 1 at 8 weeks and using device 2 at 16 weeks.
5 times sit to stand test
Time frame: Change from baseline in 5 times sit to stand test using device 1 at 8 weeks and using device 2 at 16 weeks.
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 1 May 2025.
- Derived from this study: PubMed 32976844Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, Semik P, Heinemann AW, Jayaraman A. Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):233-244. doi: 10.1016/j.apmr.2020.08.013. Epub 2020 Sep 22.
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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 in people with Spinal Cord Injuries and Poliomyelitis, 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 6 inclusion and 5 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 1 May 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 using device 1 at 8 weeks and using device 2 at 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089880, which also lists 1 linked publication.
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 1 May 2025.