C-Brace II Spinal Cord Injury

NCT03930056 | Active Not Recruiting FDA Device

• 1 other identifier: STU00208781
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

Orthotic; C-Brace

Outcome Measures

Primary Outcomes (1)

• Six Minute Walk Test (6MWT)

  The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.

  Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.

Secondary Outcomes (9)

• Muscle Strength (manual muscle test)

  Change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.

• Passive and Active Range of Motion of Lower Extremity joints

  Change from baseline in range of motion after using device at 3, 6, and 12 month follow-up.

• Modified Ashworth Scale

  Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up.

• 10 Meter Walk Test (10MWT)

  Change from baseline in gait speed after using device at 3, 6, and 12 month follow-up.

• Walking Index for Spinal Cord Injury (WISCI II)

  Change from baseline in rank score after using device at 3, 6, and 12 month follow-up.

Other Outcomes (10)

• Activities Specific Balance Confidence Scale (ABC)

  Change from baseline in score after using device at 3, 6, and 12 month follow-up.

• Modified Falls Efficacy Scale (mFES)

  Change from baseline in score after using device at 3, 6, and 12 month follow-up.

• Spinal Cord Injury Quality of Life (SCI-QOL)

  Change from baseline in score after using device at 3, 6, and 12 month follow-up.

Study Arms (2)

C-Brace II Group

EXPERIMENTAL

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

Device: C-Brace II

Traditional Group

ACTIVE COMPARATOR

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

Device: Traditional Care KAFO intervention

Interventions

C-Brace II DEVICE

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.

C-Brace II Group

Traditional Care KAFO intervention DEVICE

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.

Traditional Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be within 3-24 months post spinal cord injury diagnosis
• 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.

You may not qualify if:

• Unstable neurological, cardiovascular, or cancer diagnoses.
• Cognitive impairments that limit study participation
• Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
• 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.

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: collaborator
• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: April 16, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)