Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training
Primary Purpose
Stroke
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Electrical Stimulation with Intramuscular Electrodes
Body Weight Supported Treadmill Training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Gait Training, Motor learning, Electrical stimulation, Body Weight supported Treadmill Training, Cerebrovascular Accident
Eligibility Criteria
Inclusion Criteria: Stroke 1-11 months ago Inability to move leg normally Exclusion Criteria: Pacemaker Progressive medical condition (i.e. Parkinsons Disease)
Sites / Locations
- Cleveland VA Medical Center; Research Service
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00101543
First Posted
January 10, 2005
Last Updated
February 3, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00101543
Brief Title
Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training
Official Title
Gait Training For Acute Stroke: FNS and Weight Supported Treadmill Training
Study Type
Interventional
2. Study Status
Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
Detailed Description
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. Additionally, co-variates will be assessed at entry into the study: gender, age, mood, co-morbidities, time since stroke, and weeks of prior rehabilitation. Data for outcome measures will be collected at weeks 1, 6, 12, and 6 months after the end of treatment. For Hypothesis I testing, contrasts will be made between the two treatment groups. A separate regression model will be analyzed for each outcome measure. The post-test score for a given primary outcome measure will serve as the dependent variable in a regression model. The two independent variables will be the treatment assignment information (as a dichotomous variable) and the pretest score on the given outcome measure (the covariate). In additional model analyses for the second set of hypotheses, the relationships will be ascertained between mobility restoration and impairment, function, and quality of life. Mobility deficits following stroke pose a significant economic, social, and psychological hardship to the individual and to society. Development of techniques that improve lower extremity function will improve the quality of life and reduce associated health care costs for patients after stroke. The results of the proposed study have the potential to provide a new acute stroke treatment that will increase the rate of recovery, produce a more comprehensive recovery of motor function, safer gait, greater functional independence, and enhanced quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Gait Training, Motor learning, Electrical stimulation, Body Weight supported Treadmill Training, Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation with Intramuscular Electrodes
Intervention Type
Procedure
Intervention Name(s)
Body Weight Supported Treadmill Training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stroke 1-11 months ago
Inability to move leg normally
Exclusion Criteria:
Pacemaker
Progressive medical condition (i.e. Parkinsons Disease)
Facility Information:
Facility Name
Cleveland VA Medical Center; Research Service
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training
We'll reach out to this number within 24 hrs