C-Brace II Spinal Cord Injury

Last updated: November 20, 2024
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Spinal Cord Disorders

Treatment

Traditional Care KAFO intervention

C-Brace II

Clinical Study ID

NCT03930056
STU00208781
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

All participants:

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-monthhome trial period on and off and sufficient memory ability to wear the devices eachday during use of the orthoses.

Exclusion

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

  • Leg length discrepancy in excess of 6" (15.24 cm)

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

  • Inability to successfully use C-Brace trial tool in advancement of leg/s.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Traditional Care KAFO intervention
Phase:
Study Start date:
April 16, 2019
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Shirley Ryan AbilityLab

    Chicago, Illinois 60611
    United States

    Site Not Available

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