Knee-Ankle-Foot Braces for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

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.

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

I am between 18 and 80 years old.

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.

My heart, brain, or cancer condition is stable.

My knee or hip cannot fully straighten, bending more than 10 degrees.

My legs differ in length by more than 6 inches.

I experience moderate to severe muscle stiffness.

I cannot use the C-Brace tool effectively to move my legs.

My knee bends inward or outward more than 10 degrees.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: C-Brace II GroupExperimental Treatment1 Intervention

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

Group II: Traditional GroupActive Control1 Intervention

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