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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment C-Brace II, Traditional Care KAFO intervention for spinal cord injury?

The C-Brace microprocessor-controlled leg orthosis has been shown to improve balance, reduce the risk of falling, and enhance mobility and quality of life for individuals with lower limb weakness, suggesting potential benefits for spinal cord injury patients. ^{1 2 3 4 5}

Is the use of knee-ankle-foot braces, like C-Brace II, generally safe for people with spinal cord injuries?

There is limited specific safety data available for knee-ankle-foot braces like C-Brace II in spinal cord injury trials, but general safety reporting in these trials is often unsatisfactory, with many not clearly distinguishing severe adverse events. ^{3 4 6 7 8}

How is the C-Brace II treatment different from other treatments for spinal cord injury?

The C-Brace II is unique because it uses a microprocessor to control the movement of the knee and ankle, allowing for smoother and more adaptive walking compared to traditional braces. This technology helps improve balance, reduce the risk of falling, and enhance mobility and quality of life for individuals with lower limb weakness or paralysis. ^{2 3 4 5 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Spinal cord lesions and lower extremity bracing: an overview and follow-up study. [2004]

2. England pubmed.ncbi.nlm.nih.gov

A microprocessor stance and swing control orthosis improves balance, risk of falling, mobility, function, and quality of life of individuals dependent on a knee-ankle-foot orthosis for ambulation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mobility for persons with spinal cord injury: an evaluation of two systems. [2004]

4. France pubmed.ncbi.nlm.nih.gov

A functional comparison of conventional knee-ankle-foot orthoses and a microprocessor-controlled leg orthosis system based on biomechanical parameters. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Vannini-Rizzoli stabilizing orthosis (boot): preliminary report on a new ambulatory aid for spinal cord injury. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

7. United States 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. [2019]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Braces and splints for musculoskeletal conditions. [2007]