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

William Marsh Rice University2 sites in 1 country14 target enrollmentMay 2014

ConditionsSpinal Cord Injuries

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: William Marsh Rice University
Enrollment: 14
Locations: 2
Primary Endpoint: Change in ARAT score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

September 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

William Marsh Rice University

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in ARAT score

Time Frame: 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 Outcomes

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)
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)