Innovative Modalities for Restoring Upper Limb Function Post Stroke
1 other identifier
interventional
35
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2012
CompletedFirst Posted
Study publicly available on registry
November 14, 2012
CompletedNovember 14, 2012
November 1, 2012
8.3 years
November 9, 2012
November 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl Meyer
impairment measure of coordination of the upper limb
after 12 weeks of intervention
Study Arms (3)
Motor Learning
EXPERIMENTALsubjects are provided with intensive motor learning training of the upper limb
Robotics and Motor Learning
EXPERIMENTALsubject are provided with intensive motor learning and robotics training of the upper limb
Motor learning and FES
EXPERIMENTALsubjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb
Interventions
training of the hemiplegic upper limb with motor learning
subjects perform training of hemiplegic arm using an upper extremity robot
subjects are provided with surface FES to the hemiplegic upper limb
Eligibility Criteria
You may qualify if:
- \>1 year post stroke no acute, uncontrolled medical condition single stroke
You may not qualify if:
- pacemaker other neurological condition more than one stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Cleveland, Ohio, 44118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2012
First Posted
November 14, 2012
Study Start
September 1, 2001
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 14, 2012
Record last verified: 2012-11