C-Brace II Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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Micro-Processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Usage in a Spinal Cord Injury (SCI) Population Compared to Traditional Rehabilitation Methods: Determining Functional Outcome Differences of Recovery

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: C-Brace II
* Device: Traditional Care KAFO intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-Brace II Group<br>Subjects will be assigned a C-Brace II orthotic for use. | Device: C-Brace II<br>* 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.<br>|
| Active Comparator: Traditional Group<br>Subjects will continue with their own KAFO (non C-Brace II) use. | Device: Traditional Care KAFO intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength (manual muscle test) | Muscle strength will be assessed by a trained clinical researcher | 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 | A scale used to measure the amount of tone in individuals with neurologic diagnoses. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. | Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up. | 
| 10 Meter Walk Test (10MWT) | This test will examine the patient's gait speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10 meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundred of a second (ex: 2.15 sec). The test will be recorded 6 times: 3 times at the patient's self-selected speed, and 3 times at the patient's quickest, yet safest speed. The average of each of the 3 times will be recorded. Adequate rest in between trials will be given. | 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) | A rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces, and physical assistance of one or more persons. | Change from baseline in rank score after using device at 3, 6, and 12 month follow-up. | 
| Functional Gait Assessment (FGA) | The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device. | Change from baseline in FGA score after using device at 3, 6, and 12 month follow-up. | 
| Berg Balance Scale (BBS) | The Berg Balance Scale is a 14-item scale designed to measure balance in adults in a clinical setting. When scoring, the lowest response category that applies should be recorded. In each item, points should be deducted if the time or distance requirements are not met, the subject's performance requires supervision, or the subject requires assistance from support or examiner. | Change from baseline in Berg Balance score after using device at 3, 6, and 12 month follow-up. | 
| Timed Up and Go test (TUG) | A test which times the ability of a patient to stand up from a standard chair with arm rests, walk 3 meters forward, turn around, walk 3 meters back to the chair, and sit back down in the chair. | Change from baseline in TUG score after using device at 3, 6, and 12 month follow-up. | 
| Gaitrite data capture | The Gaitrite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The Gaitrite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The Gaitrite electronic walkway for the study shall be a minimum of 14 feet long. The Gaitrite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the Gaitrite electronic walkway. | Change from baseline in gait parameters after using device at 3, 6, and 12 month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-Brace, Orthotic