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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assist-As-Needed Control | Experimental | 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. |
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| Subject-Triggered Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAHI Exo-II | Device |
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| 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 |
| 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 |
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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:
Exclusion Criteria: Subjects will be excluded if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia K. O'Malley, PhD | William Marsh Rice University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rice University | Houston | Texas | 77005 | United States | ||
| TIRR Memorial Hermann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28659784 | Derived | Frullo JM, Elinger J, Pehlivan AU, Fitle K, Nedley K, Francisco GE, Sergi F, O'Malley MK. Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial. Front Neurorobot. 2017 Jun 13;11:26. doi: 10.3389/fnbot.2017.00026. eCollection 2017. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| Houston |
| Texas |
| 77030 |
| United States |