C-Brace II Spinal Cord Injury

NAActive, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 16, 2019

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Spinal Cord Injury
Interventions
DEVICE

C-Brace II

"Participant will complete 3-6 orthoses sessions to complete clinical evaluations and fittings conducted by certified orthotists.~Participant will receive 10-20, one hour training sessions over 1-2 months in the lab. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention.~Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row.~Participant will take the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing."

DEVICE

Traditional Care KAFO intervention

Participant will continue with use of their own KAFO. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab, if Patient is not already receiving care in a therapy setting. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will continue with the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.

Trial Locations (1)

60611

Shirley Ryan AbilityLab, Chicago

All Listed Sponsors
collaborator

Otto Bock Healthcare Products GmbH

INDUSTRY

lead

Shirley Ryan AbilityLab

OTHER