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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00508521 |
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 |
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Stroke |
Device: Functional Electrical Stimulation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | Treatment of Hand Dysfunction After Stroke |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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. |
Principal Investigator: | Janis J Daly, Ph.D., M.S. | LSCDVAMC |
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 |
motor learning Electrical Stimulation cerebrovascular accident upper extremity rehabilitation |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |