Micro-Processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Usage in a Spinal Cord Injury (SCI) Population Compared to Traditional Rehabilitation Methods: Determining Functional Outcome Differences of Recovery

Shirley Ryan AbilityLab1 site in 1 country30 target enrollmentApril 16, 2019

ConditionsSpinal Cord Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: Shirley Ryan AbilityLab
Enrollment: 30
Locations: 1
Primary Endpoint: Six Minute Walk Test (6MWT)
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 16, 2019

End Date

November 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shirley Ryan AbilityLab

Responsible Party

Principal Investigator

Arun Jayaraman, PT, PhD

Research Scientist

Shirley Ryan AbilityLab

Eligibility Criteria

Inclusion Criteria

•Be within 3-24 months post spinal cord injury diagnosis
•18-80 years
•Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.

Exclusion Criteria

•Unstable neurological, cardiovascular, or cancer diagnoses.
•Cognitive impairments that limit study participation
•In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II):
•Inclusion criteria:
•Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
•Exclusion criteria:
•Body weight over 275 lbs
•Flexion contracture in the knee and/or hip joint in excess of 10 degrees
•Non-correctable knee varus/valgus in excess of 10 degrees
•Moderate to severe spasticity

Outcomes

Primary Outcomes

Six Minute Walk Test (6MWT)

Time Frame: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.

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.

Secondary Outcomes

Functional Gait Assessment (FGA)(Change from baseline in FGA score after using device at 3, 6, and 12 month follow-up.)
10 Meter Walk Test (10MWT)(Change from baseline in gait speed after using device at 3, 6, and 12 month follow-up.)
Muscle Strength (manual muscle test)(Change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.)
Passive and Active Range of Motion of Lower Extremity joints(Change from baseline in range of motion after using device at 3, 6, and 12 month follow-up.)
Modified Ashworth Scale(Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up.)
Berg Balance Scale (BBS)(Change from baseline in Berg Balance score after using device at 3, 6, and 12 month follow-up.)
Timed Up and Go test (TUG)(Change from baseline in TUG score after using device at 3, 6, and 12 month follow-up.)
Walking Index for Spinal Cord Injury (WISCI II)(Change from baseline in rank score after using device at 3, 6, and 12 month follow-up.)
Gaitrite data capture(Change from baseline in gait parameters after using device at 3, 6, and 12 month follow-up.)