C-Brace II Spinal Cord Injury

Technology

Standing/walking/mobility

Online since 4 November 2021, updated 756 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.

Wings for Life supports SCITrialsFinder

Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

Learn more

Back to results