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NCT00508521 · ClinicalTrials.gov registry record · NA
Treatment of Hand Dysfunction After Stroke
A NA study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT00508521 is a NA study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 4 participants.
The verdict
NCT00508521, a NA study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study 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-bli
Interventions
- OTHER Standard Care
- DEVICE Functional Electrical Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00508521
The ClinicalTrials.gov registry entry for NCT00508521 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT00508521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00508521 about?
NCT00508521 is a clinical study titled "Treatment of Hand Dysfunction After Stroke". 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...
What is the current status of trial NCT00508521?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2007-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00508521?
The interventions under investigation include: Standard Care (OTHER), Functional Electrical Stimulation (DEVICE).
Who is sponsoring clinical trial NCT00508521?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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