C-Brace II Spinal Cord Injury

Shirley Ryan AbilityLab

Status: Active, not recruiting

Conditions: Spinal Cord Injury

Treatments: Device: C-Brace II; Device: Traditional Care KAFO intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03930056

STU00208781

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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-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
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

C-Brace II Group

Experimental group

Description:

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

Treatment:

Device: C-Brace II

Traditional Group

Active Comparator group

Description:

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

Treatment:

Device: Traditional Care KAFO intervention