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Clinical Trials/NCT02803255
NCT02803255CompletedPhase 1

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

William Marsh Rice University4 sites in 1 country14 target enrollmentStarted: May 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
14
Locations
4
Primary Endpoint
Change in ARAT score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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