AAN Robotic Therapy in SCI

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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: MAHI Exo-II

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR Memorial Hermann
    • Houston, Texas, United States, 77005
      • Rice University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assist-As-Needed Control; 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.	Device: MAHI Exo-II; Other Names: Robot-aided movement therapy
Active Comparator: Subject-Triggered Control; 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.	Device: MAHI Exo-II; Other Names: Robot-aided movement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: William Marsh Rice University
• Investigators: Principal Investigator: Marcia K. O'Malley, PhD, William Marsh Rice University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Injuries; Spinal Cord
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 14-027F