AAN Robotic Therapy in SCI

NCT02803255 | Completed Phase 1

• 1 other identifier: 14-027F
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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).

Conditions

Spinal Cord Injuries

Keywords

Injuries; Spinal Cord

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

Study Arms (2)

Assist-As-Needed Control

EXPERIMENTAL

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

Subject-Triggered Control

ACTIVE COMPARATOR

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

Interventions

MAHI Exo-II DEVICE

Also known as: Robot-aided movement therapy

Assist-As-Needed Control; Subject-Triggered Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Marsh Rice University: lead

Study Sites (2)

Rice University

Houston, Texas, 77005, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28659784 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System

Study Officials

• Marcia K. O'Malley, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 16, 2016
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 16, 2016

Record last verified: 2016-05

Locations

US (2)