Knee-Ankle-Foot Braces for Spinal Cord Injury

Overseen By Sara Prokup

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Unstable neurological, cardiovascular, cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee-ankle-foot brace called the C-Brace II. The goal is to determine if it benefits people with spinal cord injuries more than traditional braces. Participants will either use the C-Brace II or continue with their current brace to compare outcomes. Ideal participants have had a spinal cord injury for 3 to 24 months and require braces for leg stability. As an unphased trial, this study allows participants to contribute to innovative research that could enhance mobility solutions for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these knee-ankle-foot orthoses are safe for use in spinal cord injury patients?

Research shows that the C-Brace II, a special brace with a built-in computer, is generally easy for users to adapt to. One study on similar devices found that users walked better with them than with regular braces, indicating that the computer design aids movement without causing harm.

Although long-term safety information is not yet available, current studies have not identified any major side effects with the C-Brace II. Designed to enhance mobility and improve quality of life, it is particularly beneficial for those with mobility issues. Overall, existing evidence suggests that the C-Brace II is safe to use, but further studies will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The C-Brace II is unique because it offers a dynamic and intelligent approach to knee-ankle-foot orthotic support for individuals with spinal cord injuries. Unlike standard rigid KAFOs, the C-Brace II uses sensors and microprocessors to adapt in real-time to the wearer's movements, providing a more natural and fluid walking experience. Researchers are excited about this technology because it not only enhances mobility but also improves safety and comfort, potentially leading to a significant improvement in the quality of life for users.

What evidence suggests that these knee-ankle-foot braces could be effective for spinal cord injury?

Research shows that the C-Brace II, a high-tech leg brace, helps people with lower limb difficulties move better. Studies have found that it improves quality of life by easing movement and boosting confidence. Evidence suggests it is especially beneficial for those recovering from spinal cord injuries, aiding in rehabilitation and daily activities. In this trial, participants in the C-Brace II Group will use this advanced technology, which offers better walking control and leads to significant improvements over traditional braces. Meanwhile, participants in the Traditional Group will continue using their own KAFO (non C-Brace II). ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are within 3-24 months post spinal cord injury. Participants must need lower extremity bracing, be able to charge and remember to wear devices daily, and weigh under 275 lbs. Those with unstable health conditions, severe spasticity, or significant leg length discrepancies cannot join.

Inclusion Criteria

I can charge and remember to wear the trial devices daily for 3 months.

I was diagnosed with a spinal cord injury between 3 to 24 months ago.

I need a brace for my leg or legs due to instability.

Exclusion Criteria

I do not have cognitive impairments that limit my participation.

I cannot keep my upper body stable, even with support like a cane.

My body weight is over 275 lbs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned either a C-Brace II orthotic or continue with their own KAFO for use

12 months

Regular follow-up visits at 3, 6, and 12 months

Follow-up

Participants are monitored for changes in muscle strength, gait speed, balance, and quality of life

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• C-Brace II
• Traditional Care KAFO intervention

Trial Overview The study compares a microprocessor-controlled knee-ankle-foot orthosis (C-Brace II) with traditional care models in people after spinal cord injury rehab. It's randomized and measures how each orthosis affects the user over a three-month period at home.

How Is the Trial Designed?

Group I: C-Brace II Group Experimental Treatment 1 Intervention

Subjects will be assigned a C-Brace II orthotic for use.

Group II: Traditional Group Active Control 1 Intervention

Subjects will continue with their own KAFO (non C-Brace II) use.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Otto Bock Healthcare Products GmbH

Industry Sponsor

Trials

16

Recruited

880+

Published Research Related to This Trial

Unloader (valgus) knee braces are effective for reducing pain in patients with osteoarthritis in the medial compartment of the knee, supported by good evidence.

Functional ankle braces are preferred over immobilization for treating acute ankle sprains and can help prevent future sprains, while a neutral wrist splint can improve symptoms of carpal tunnel syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braces and splints for musculoskeletal conditions. Gravlee, JR., Van Durme, DJ.[2007]

Pregabalin was found to be effective for managing neuropathic pain in chronic spinal cord injury patients, with strong evidence from multiple studies, while cannabinoids were deemed ineffective for the same condition.

Adverse events (AEs) such as dizziness and somnolence were common, leading to withdrawal rates that varied significantly across different medication types, highlighting the need for better reporting of AEs in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy, Adverse Events, and Withdrawal Rates of the Pharmacological Management of Chronic Spinal Cord Injury Pain: A Systematic Review and Meta-Analysis. Canavan, C., Inoue, T., McMahon, S., et al.[2022]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

Functional electrical stimulation (FES) provided greater or equal independence in mobility activities for children with motor-complete thoracic level spinal cord injuries compared to long leg braces (LLB), with 94% of comparisons showing less assistance needed with FES.

Children completed mobility tasks faster using FES, with significant time savings in two activities, and 62% of participants preferred FES over LLB, indicating a strong preference for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of functional electrical stimulation to long leg braces for upright mobility for children with complete thoracic level spinal injuries. Bonaroti, D., Akers, JM., Smith, BT., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11316271/

The C-Brace® microprocessor controlled stance and swing ... The C-Brace microprocessor-controlled stance and swing control orthosis has been shown to improve function, mobility, and quality of life.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03930056/c-brace-ii-spinal-cord-injury

C-Brace II Spinal Cord Injury | Clinical Research Trial Listing A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional ...

3. corporate.ottobock.com corporate.ottobock.com/en/media/newsroom/advancing-meuromobility-latest-clinical-insights-for-exopulse-mollii-suit-and-c-brace

Latest Clinical Insights for Exopulse Mollii Suit and C-Brace Experts shared recent results about the neuromodulation suit in Multiple sclerosis (MS) including the promising impact in balance, spasticity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02089880

Study Details | NCT02089880 | Comparing Functional ... 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 ...

5. ottobock.com ottobock.com/en-sc/news-enhanced-rehabilitation-potential-SCI

Enhancing rehabilitation potential in patients with SCI These findings indicate that C-Brace has a valuable role to play in unlocking the full rehabilitation potential of patients with traumatic spine injuries.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5302081/

Safety and walking ability of KAFO users with the C-Brace® ... The aim of this study was to evaluate the potential benefits of a microprocessor stance and swing control orthosis compared to stance control orthoses and ...

7. assets.ctfassets.net assets.ctfassets.net/6ip7bnhvpajs/1IaCW0Y3EJ4wIiMVjmbyFP/5e657e70b8a9c34b8aebb1a7215cf262/c-brace-study-summaries.pdf

C-Brace The knee extension moment slightly increased in the second half of the stance phase in comparison to SCO (0.52 vs. 0.57) and decreased considerably in ...