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Treatment of Hand Dysfunction After Stroke
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, July 2007
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00508521
  Purpose

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 neuromuscular stimulation (FNS; surface FNS; 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 FNS and ML (FNS ML). In our pilot studies, FNS ML for those in the chronic phase (>12 months) produced statistically significant functional recovery. FNS was applied using a commercially available, two-channel FNS 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 FNS 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. FNS 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 FNS 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.

FNS 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 FNS. FNS 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 Intervention
Stroke
Device: Functional Electrical Stimulation

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Treatment of Hand Dysfunction After Stroke

Further study details as provided by Department of Veterans Affairs:

Study Start Date: January 2007
Estimated Study Completion Date: January 2009
Intervention Details:
    Device: Functional Electrical Stimulation
    commercially available surface electrical stimulator
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Parkinsons Disease)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508521

Contacts
Contact: Jessica P McCabe, M.P.T. 216-791-3800 ext 4691 jessicapmccabe@hotmail.com
Contact: Jean Rogers, P.T. 216-791-32800 ext 3830 j_m_rogers@hotmail.com

Locations
United States, Ohio
Louis Stokes Cleveland Department of Veterans Affairs Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jessica McCabe, M.P.T.     216-791-3800 ext 4691     jessicapmccabe@hotmail.com    
Contact: Jean Rogers, P.T.     216-791-3800 ext 3830     j_m_rogers@hotmail.com    
Principal Investigator: Janis J Daly, Ph.D., M.S.            
Sponsors and Collaborators
Investigators
Principal Investigator: Janis J Daly, Ph.D., M.S. LSCDVAMC
  More Information

Study ID Numbers: B4078R
Study First Received: July 27, 2007
Last Updated: August 27, 2008
ClinicalTrials.gov Identifier: NCT00508521  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
motor learning
Electrical Stimulation
cerebrovascular accident
upper extremity rehabilitation

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009