Spinal Cord Injuries
Conditions
Keywords
Injuries, Spinal Cord
Brief summary
The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the assist-as needed paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).
Interventions
DEVICEMAHI Exo-II
Sponsors
William Marsh Rice University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area. Inclusion Criteria: 1. Providing written informed consent prior to any study related procedures; 2. Age between 18-75 years; 3. Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months; 4. Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months; 5. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; 6. Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation); 7. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
Exclusion criteria
Subjects will be excluded if they have: 1. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score \> than 3 out of 4; 2. Subject who cannot provide self-transportation to the study location.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ARAT score | Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Ashworth Scale | Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program | — |
| Change in Grip Pinch Strength Assessment | Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program | — |
| Change in Graded Redefined Assessment of Strength, Sensibility and Prehension | Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program | — |
| Change in Smoothness metrics | Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program | Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed |
| Change in smoothness metrics | Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start | Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed |
Countries
United States
Outcome results
None listed