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Clinical Trials/NCT02331407
NCT02331407CompletedNot Applicable

Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

Columbia University1 site in 1 country9 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
1
Primary Endpoint
Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Arms & Interventions

Robot arm rehabilitation therapy

Experimental

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

Intervention: Robotic arm therapy (Device)

Outcomes

Primary Outcomes

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

Time Frame: From baseline to within 1 week post-therapy

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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