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Innovative Modalities for Restoring Upper Limb Function Post Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725659
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janis Daly, Malcom Randall VA Medical Center
  Purpose
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).

Condition Intervention
Cerebrovascular Accident Other: Motor Learning Other: Robotics Other: surface FES

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Innovative Modalities for Restoring Upper Limb Function Post Stroke

Further study details as provided by Janis Daly, Malcom Randall VA Medical Center:

Primary Outcome Measures:
  • Fugl Meyer [ Time Frame: after 12 weeks of intervention ]
    impairment measure of coordination of the upper limb


Enrollment: 35
Study Start Date: September 2001
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motor Learning
subjects are provided with intensive motor learning training of the upper limb
Other: Motor Learning
training of the hemiplegic upper limb with motor learning
Experimental: Robotics and Motor Learning
subject are provided with intensive motor learning and robotics training of the upper limb
Other: Motor Learning
training of the hemiplegic upper limb with motor learning
Other: Robotics
subjects perform training of hemiplegic arm using an upper extremity robot
Experimental: Motor learning and FES
subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb
Other: Motor Learning
training of the hemiplegic upper limb with motor learning
Other: surface FES
subjects are provided with surface FES to the hemiplegic upper limb

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >1 year post stroke no acute, uncontrolled medical condition single stroke

Exclusion Criteria:

  • pacemaker other neurological condition more than one stroke
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725659


Locations
United States, Ohio
Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Cleveland, Ohio, United States, 44118
Sponsors and Collaborators
Malcom Randall VA Medical Center
  More Information

Responsible Party: Janis Daly, Principal Investigator, Malcom Randall VA Medical Center
ClinicalTrials.gov Identifier: NCT01725659     History of Changes
Other Study ID Numbers: B2801R
First Submitted: November 9, 2012
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Janis Daly, Malcom Randall VA Medical Center:
Stroke
electric stimulation
robotics
motor learning

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases