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NCT00101543 · ClinicalTrials.gov registry record · Phase 4
Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training
A Phase 4 study of Stroke, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT00101543 is a Phase 4 study of Stroke that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 70 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00101543, a Phase 4 study of Stroke, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Conventional rehabilitation does not restore normal, safe gait to many stroke survivors. Functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM) improved persistent gait deficits for patients with chronic stroke (1-7 years post stroke), but required a long protocol of 6-18 months. For chronic deficits, a shortened response to treatment (3 months) was obtained by combining FNS-IM with body weight-supported treadmill training (BWSTT). Gains included strength, coordination, gait kinematics, walking endurance, and quality of life. Gait deficits treated in the chronic phase are more resistant to treatment than in the early recovery phase, because chronic, abnormal movement patterns are more ingrained. Therefore, during the early recovery phase, it is likely that a relatively greater treatment response will be obtained. The purpose of the proposed work is to test the combination FNS-IM + BWSTT during the early recovery phase following stroke. Hypothesis I is: FNS-IM + BWSTT will restore volitional gait more completely for subjects during the early recovery phase following stroke, compared to BWSTT alone. Subjects will be admitted at 1-11 months after stroke. Thirty five subjects will be randomized to one of the two treatment groups. They will be treated for 48 sessions, four sessions/week. Primary outcome measures will be: kinematic swing phase gait components, energy cost of gait, and an index of walking endurance. Secondary outcome measures will be kinematic stance phase gait components and gait speed. The second set of hypotheses will test the relationship between restoration of mobility and measurements of impairment, function and quality of life.
Conditions Studied
Interventions
- PROCEDURE Body Weight Supported Treadmill Training
- DEVICE Electrical Stimulation with Intramuscular Electrodes
Study Locations (1)
Ohio
- Cleveland VA Medical Center; Research Service - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2003-08 |
| Est. Completion | 2006-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00101543
The ClinicalTrials.gov registry entry for NCT00101543 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Body Weight Supported Treadmill Training is the first listed.
NCT00101543 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00101543 about?
NCT00101543 is a clinical study titled "Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training". Conventional rehabilitation does not restore normal, safe gait to many stroke survivors. Functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM) improved persistent gait deficits for patients with chronic stroke (1-7 years post stroke), but required a long protocol of...
What is the current status of trial NCT00101543?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2003-08. Estimated completion is 2006-08.
What conditions does trial NCT00101543 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT00101543?
The interventions under investigation include: Body Weight Supported Treadmill Training (PROCEDURE), Electrical Stimulation with Intramuscular Electrodes (DEVICE).
Who is sponsoring clinical trial NCT00101543?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00101543 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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