Innovative Modalities for Restoring Upper Limb Function Post Stroke

• Sponsor: Malcom Randall VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01725659
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 3
• Duration (Months): 99
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Other: Motor Learning; Other: Robotics; Other: surface FES	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Innovative Modalities for Restoring Upper Limb Function Post Stroke
• Study Start Date: Sep 1, 2001
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Fugl Meyer [after 12 weeks of intervention]

   impairment measure of coordination of the upper limb

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Louis Stokes Cleveland Department of Veterans Affairs Medical Center	Cleveland	Ohio	United States	44118

Sponsors and Collaborators

• Malcom Randall VA Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janis Daly, Principal Investigator, Malcom Randall VA Medical Center
• ClinicalTrials.gov Identifier: NCT01725659
• Other Study ID Numbers: B2801R
• First Posted: Nov 14, 2012
• Last Update Posted: Nov 14, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Janis Daly, Principal Investigator, Malcom Randall VA Medical Center: Stroke; electric stimulation; robotics; motor learning
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Nov 14, 2012