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Orthosis

Knee-Ankle-Foot Braces for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally

Aged 18-80 years

Must not have

Cognitive impairments that limit study participation

Inability to stabilize the trunk with or without assistive devices (crutches, cane, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline in score after using device at 3, 6, and 12 month follow-up.

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of knee-ankle-foot braces to see which is more effective following discharge from inpatient rehab.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort from wearing the braces, skin issues where the brace contacts the body, and possible muscle or joint pain due to changes in movement patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have cognitive impairments that limit my participation.

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

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My body weight is over 275 lbs.

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My heart, brain, or cancer condition is stable.

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

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My legs differ in length by more than 6 inches.

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I experience moderate to severe muscle stiffness.

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

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My knee bends inward or outward more than 10 degrees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up. for reporting.