Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101543
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2005-01-10
Brief Title:
Gait Training For Acute Stroke Functional Neuromuscular Stimulation FNS and Weight Supported Treadmill Training
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Gait Training For Acute Stroke FNS and Weight Supported Treadmill Training
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sessionsweek 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 sessionsweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None