AAN Robotic Therapy in SCI

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803255
• Other study ID #: 14-027F
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2016
• Last updated: June 13, 2016
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: William Marsh Rice University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• MAHI Exo-II

Locations

Country	Name	City	State
United States	Rice University	Houston	Texas
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No