Treatment of Hand Dysfunction After Stroke

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. Identifier: NCT00508521
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper limb. There is some promising information that suggests motor learning (ML) in conjunction with functional electrical stimulation (FES; surface FES; nothing implanted; use of a commercially available system) of wrist/finger muscles can significantly enhance the functional level of the upper limb. There have been promising studies showing that some subjects in the chronic phase (greater than 6 months after stroke) responded favorably to combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase (>12 months) produced statistically significant functional recovery. FES was applied using a commercially available, two-channel FES system, with electrodes applied to the surface of the skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within the sub-acute phase (less than 6 months) following stroke, the following problems can develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal, non-functional movement patterns. The more long-standing these symptoms are, the more resistant to treatment they become. Therefore, it is important to provide promising interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute phase after stroke should be provided with FES ML, in order to more completely restore function for a greater number of stroke survivors.

Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the proposed treatment in the sub acute phase following stroke.

HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement in the sub-acute phase following stroke (2 -24 weeks).

Study Design

a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for upper extremity rehabilitation in a sub-acute stroke population. It is a randomized, controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The control group will receive standard care for upper limb rehabilitation consisting of passive and active exercise, stretching, bracing, and use of adaptive devices. The experimental group will receive the experimental intervention in addition to their standard care.

CONTROL GROUP INTERVENTION. The control group will receive the standard medical care prescribed by the primary physician and covered by the subject's health care policy. Standard care will include: soft tissue mobilization; assisted motion exercise; active motion exercise; resistive exercise; task practice; use of assistive devices; and modality applications conventionally prescribed.

FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week. The subjects will be present for a fourth hour each day, which will be used for breaks and rest periods that will be interspersed throughout the intervention time. The treatment duration is derived from prior work. We will stimulate muscles in a number of configurations including: wrist extension and finger extension; wrist extension and finger flexion; and wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will include the performance of functional task components and full task practice during the use of FES. FES will be triggered by the patient, the treating therapist, or it will be automatically sequenced by the device according to alternate channel activations, with timings pre-set by the treating therapist.

MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the end of treatment.

Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).

Condition or disease Intervention/treatment Phase
Stroke Device: Functional Electrical Stimulation Other: Standard Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Hand Dysfunction After Stroke
Study Start Date : January 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: FES and Motor Learning Training
participants <6 months after first stroke who presented with arm dysfunction were trained using FES and Motor Learning
Device: Functional Electrical Stimulation
commercially available surface electrical stimulator

Control group
Subjects in this arm will receive standard care as prescribed by their physician and covered by their insurance
Other: Standard Care
Standard care as ordered by their physician and covered by their insurance company.

Primary Outcome Measures :
  1. Fugl-Meyer Upper Limb Coordination Scale (FMUE) [ Time Frame: baseline and after 12 weeks of training ]
    A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 2-24 weeks after stroke
  • Greater than 21 years old
  • Ability to follow 2 step commands

Exclusion Criteria:

  • Chronic, progressive medical condition (i.e. Parkinson's Disease)

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 identifier (NCT number): NCT00508521

United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Janis Daly, PhD MS VA Medical Center, Cleveland

Responsible Party: VA Office of Research and Development Identifier: NCT00508521     History of Changes
Other Study ID Numbers: B4078-R
First Posted: July 30, 2007    Key Record Dates
Results First Posted: February 7, 2014
Last Update Posted: February 7, 2014
Last Verified: December 2013

Keywords provided by VA Office of Research and Development:
cerebrovascular accident
electrical stimulation
motor learning
upper extremity rehabilitation

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