Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

NCT02331407 | Completed Results

• 1 other identifier: AAAD3437
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance

  Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.

  From baseline to within 1 week post-therapy

Secondary Outcomes (2)

• Fugl-Meyer (FM) Upper Extremity Motor Assessment

  baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

• Action Research Arm Test

  baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

Study Arms (1)

Robot arm rehabilitation therapy

EXPERIMENTAL

Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.

Device: Robotic arm therapy

Interventions

Robotic arm therapy DEVICE

Training with the ReoGo device

Robot arm rehabilitation therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiparesis of the upper extremity
• Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry
• Age 18 years or older
• Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.

You may not qualify if:

• Inability to understand and/or follow instructions
• Pain in shoulder or arm
• Other neurological or musculoskeletal target organ disorder
• Inability to give informed consent personally
• Previous or current contracture of the upper extremity

Sponsors & Collaborators

• Columbia University: lead
• Orentreich Family Foundation: collaborator
• Mailman School of Public Health: collaborator

Study Sites (1)

Columbia Univeristy, Neurological Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Tomoko Kitago
• Organization: Columbia University

tk2229@columbia.edu

212-305-8389

Study Officials

• John Krakauer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 6, 2015
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-04

Locations

US (1)