AAN Robotic Therapy in SCI

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: MAHI Exo-II


Participation Criteria
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Eligibility Criteria
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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: Providing written informed consent prior to any study related procedures; Age between 18-75 years; 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; Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months; No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation); 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: Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4; Subject who cannot provide self-transportation to the study location.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assist-As-Needed Control<br>Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an adaptive mode. In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an assist-as-needed protocol. Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion. | Device: MAHI Exo-II<br> <br> * Other names: Robot-aided movement therapy;|
| Active Comparator: Subject-Triggered Control<br>Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system. In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e. elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension). The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall. | Device: MAHI Exo-II<br> <br> * Other names: Robot-aided movement therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injuries, Spinal Cord