AAN Robotic Therapy in SCI

Phase 1

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT02803255
• Lead Sponsor: William Marsh Rice University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-13
• Last Update Submitted: 2016-06-13
• Study First Posted: 2016-06-16
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (2)

Rice University; 🇺🇸 Houston, Texas, United States

TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States