C-Brace II Spinal Cord Injury

Phase

N/A

Condition

Spinal Cord Disorders

Spinal Cord Injuries

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