Source of Hand Weakness After Stroke
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Purpose
The purpose of this study is to determine whether neural block and neuromuscular electrical stimulation are effective in treating finger impairment due to stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Cerebrovascular Accident |
Drug: lidocaine Device: muscle stimulator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Source of Neurally-Mediated Hand Weakness After Stroke |
- fingertip force [ Time Frame: force measured before and after intervention (1 week later) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 8 |
| Study Start Date: | February 2009 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
persons with severe hand impairment following hemiparetic stroke
|
Drug: lidocaine
comparison of the effect of the drug to help improve finger function
Device: muscle stimulator
comparison of the effect of stimulated muscle(s) on finger function
|
|
Active Comparator: Arm 2
persons with severe hand impairment following hemiparetic stroke
|
Device: muscle stimulator
comparison of the effect of stimulated muscle(s) on finger function
|
Detailed Description:
The incidence of stroke-induced hemiparesis among veterans is likely to rise as this population ages. Post-stroke hemiparesis is often marked by persistent hand impairment, which adversely affects both a person's ability to work and his/her quality of life. We believe that impairment is primarily due to neural, rather than biomechanical, factors. At the muscle level, these factors relate either to the inability to activate muscles (i.e., low muscle activation) or to activate them appropriately (i.e., abnormal muscle co-activation). Currently it is unclear as to which one is largely responsible for weakness in the hand as the net mechanical effect, e.g., reduced fingertip force production, could be the same. Determination of voluntary muscle force generation could help to explain deficits in fingertip force production in specific directions, as well as to customize treatment approaches in which force generation ability of some muscles is decreased and others increased. The goal of this work is to explain the source of neurally-mediated weakness at the fingertip following hemiparetic stroke, and to design and experimentally test rehabilitation interventions that attempt to offset this weakness.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- clinical diagnosis of stroke;
- stroke occurred no less than 6 months prior to study;
- must have had only 1 stroke;
- must demonstrate severe hand impairment;
- must have no substantial evidence of motor and sensory deficits in non-paretic limb;
- must have no history or clinical signs of neurologic diseases other than stroke;
- must have no cognitive dysfunction that precludes comprehension of experimental tasks;
- must be able to give informed consent
Exclusion Criteria:
- taking medication that can increase the risk of lidocaine toxicity such as cimetidine (ulcer treatment drug), phenytoin (anticonvulsant drug), nadolol (drug for treatment of headache, hypertension, chest pain);
- taking anticoagulant medication, i.e., aspirin, coumadin;
- has a low platelet count or a bleeding disease
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00907829 History of Changes |
| Other Study ID Numbers: | B6302-W |
| Study First Received: | May 21, 2009 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
stroke fingertip force muscle coordination |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Lidocaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013