C-Brace II Spinal Cord Injury

Technology

Standing/walking/mobility

Online since 4 November 2021, updated 491 days ago

About this trial

This trial is enrolling individuals with spinal cord injuries to test a new knee-ankle-foot orthosis (KAFO) and its effect on walking function. Traditionally, KAFOs are used to support unstable walking (gait) during the rehabilitation process. The C-Brace II KAFO is controlled by a micro-processor. If selected for the study, participants will randomly be assigned to one of two groups, using either a traditional KAFO or the C-Brace II. The functional outcome differences over a 3-month home trial will be analyzed between the two devices. Measurements will include walking speed, balance, muscle strength, and muscle spasticity.

Included participants

Gender

All

Age

18 - 80 years

Injury level

C1 - S5

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

3 months - 24 months

Injury type

Traumatic

Non-traumatic

Healthy volunteers

C1-S5

Additionally, participants must

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

have a body weight lower than 275 lbs (=125 kg).

What’s involved

Type

Technology

Details

3-6 orthoses sessions for clinical evaluation and fitting. 10-20 one-hour training sessions over 1-2 months in the lab. Fine-tuning to the needs and preferences. First training sessions. Home-use for a 3-month period, with an activity-monitor. Outcome assessments at 3, 6, 12 months after receiving the brace for testing.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

Bladder health

Bowel health

General health

Mental health

Spasticity

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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