Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 stroke
Started Aug 2003
Typical duration for phase_4 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 10, 2005
CompletedFirst Posted
Study publicly available on registry
January 11, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFebruary 5, 2009
January 1, 2005
January 10, 2005
February 3, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Stroke 1-11 months ago
- Inability to move leg normally
You may not qualify if:
- Pacemaker
- Progressive medical condition (i.e. Parkinsons Disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland VA Medical Center; Research Service
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
January 10, 2005
First Posted
January 11, 2005
Study Start
August 1, 2003
Study Completion
August 1, 2006
Last Updated
February 5, 2009
Record last verified: 2005-01