Clinical trial NCT03930056: C-Brace II Spinal Cord Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Orthotic
C-Brace
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Otto Bock Healthcare Products GmbH
First posted: 2019-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Six Minute Walk Test (6MWT)
timeFrame: Change from baseline in 6MWT distance after using device at 3, 6, and 12 month follow-up.
Secondary outcomes:
measure: Muscle Strength (manual muscle test)
timeFrame: Change from baseline in muscle strength after using device at 3, 6, and 12 month follow-up.
measure: Passive and Active Range of Motion of Lower Extremity joints
timeFrame: Change from baseline in range of motion after using device at 3, 6, and 12 month follow-up.
measure: Modified Ashworth Scale
timeFrame: Change from baseline in muscle tone after using device at 3, 6, and 12 month follow-up.
measure: 10 Meter Walk Test (10MWT)
timeFrame: Change from baseline in gait speed after using device at 3, 6, and 12 month follow-up.
measure: Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: Change from baseline in rank score after using device at 3, 6, and 12 month follow-up.
measure: Functional Gait Assessment (FGA)
timeFrame: Change from baseline in FGA score after using device at 3, 6, and 12 month follow-up.
measure: Berg Balance Scale (BBS)
timeFrame: Change from baseline in Berg Balance score after using device at 3, 6, and 12 month follow-up.
measure: Timed Up and Go test (TUG)
timeFrame: Change from baseline in TUG score after using device at 3, 6, and 12 month follow-up.
measure: Gaitrite data capture
timeFrame: Change from baseline in gait parameters after using device at 3, 6, and 12 month follow-up.
Other outcomes:
measure: Activities Specific Balance Confidence Scale (ABC)
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: Modified Falls Efficacy Scale (mFES)
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: Spinal Cord Injury Quality of Life (SCI-QOL)
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: EQ5D-5L
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: Orthotics and Prosthetics User Survey (OPUS)
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: International Spinal Cord Injury Bowel Function Data Set
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: International Spinal Cord Injury Lower urinary Tract Basic Data Set
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: Spinal Cord Injury Bowel and Bladder Treatment Index Short Form (SCI-BBTI-SF)
timeFrame: Change from baseline in score after using device at 3, 6, and 12 month follow-up.
measure: Actigraph
timeFrame: Change from baseline measurement after using device at 3, 6, and 12 month follow-up.
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: