Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011596
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-02-22
Brief Title:
FNS and Weight Support Treadmill Training for Gait Component Restoration
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
FNS and Weight Support Treadmill Training for Gait Component Restoration
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To date conventional rehabilitation is not able to restore normal safe gait for many individuals with stroke We have identified nine gait component deficits which respond to the FNS-IM intervention This study will test a refined treatment protocol of 3 months duration to restore volitional gait by restoring those nine gait components simultaneously In addition we will incorporate into the treatment protocol a promising non-invasive technique of partial body weight-supported BWS gait training on a treadmill BWS and FNS-IM have the potential to provide additive effects for the patient and restore volitional gait more quickly and more completely than would otherwise be possible with one technique alone
Detailed Description:
Stroke is the third leading cause of disability in the United States To date conventional rehabilitation is not able to restore normal safe gait for many individuals with stroke We have identified nine gait component deficits which respond to the FNS-IM intervention This study will test a refined treatment protocol of 3 months duration to restore volitional gait by restoring those nine gait components simultaneously In addition we will incorporate into the treatment protocol a promising non-invasive technique of partial body weight-supported BWS gait training on a treadmill BWS and FNS-IM have the potential to provide additive effects for the patient and restore volitional gait more quickly and more completely than would otherwise be possible with one technique alone Therefore our first hypothesis is HYPOTHESIS I BWS combined with FNS-IM simultaneously applied to nine critical gait components will restore volitional normal safe gait to patients with chronic stroke within 3 months An advantage of BWS gait training is that it is non-invasive Consequently we must demonstrate the additive advantage of FNS-IM technique alone Therefore the second hypothesis is HYPOTHESIS II FNS-IM plus BWS will restore volitional gait more quickly and completely for patients with chronic stroke compared with BWS alone
A total of thirty six chronic stroke patients will be randomly divided into two treatment groups 1 FNS-IM plus BWS 2 BWS alone Outcome measures for hypothesis testing will be threefold 1 Gait normality kinematics of nine gait components 2 Safety number of falls 3 Functionality gait speed walking endurance and CHART a handicap measure of mobility and activity level Data will be collected every four weeks during the three months of treatment Maintenance of gains will be monitored at two additional data collections at six months and one year following the end of the treatment period Results of this study have the potential to provide the following clinically applicable information
1 For patients with stroke a refined treatment protocol of 3 months duration for restoration of normal safe volitional gait which is practical within the current healthcare milieu 2 A definitive recommendation regarding the most effective treatment for chronic stroke patients 1 BWS plus FNS-IM or 2 BWS alone
RESEARCH OBJECTIVES
1 Build stimulators and electrodes
2 Obtain measures pre and post intervention for the two groups FNS-IM BWS and BWS alone to detect gains in a gait pattern b safety c functional capability and d quality of life
3 Analyze data for the group receiving FNS-IM BWS in order to test
Hypothesis I
4 Produce therapy protocols for FNS-IM and BWS intervention and treatment progression
5 Test Hypothesis II by comparing the two treatment groups BWS vs BWS FNS-IM
A total of thirty six chronic stroke patients will be randomly divided into two treatment groups 1 FNS-IM plus BWS 2 BWS alone Outcome measures for hypothesis testing will be threefold 1 Gait normality kinematics of nine gait components 2 Safety number of falls 3 Functionality gait speed walking endurance and CHART a handicap measure of mobility and activity level Data will be collected every four weeks during the three months of treatment Maintenance of gains will be monitored at two additional data collections at six months and one year following the end of the treatment period Results of this study have the potential to provide the following clinically applicable information
1 For patients with stroke a refined treatment protocol of 3 months duration for restoration of normal safe volitional gait which is practical within the current healthcare milieu 2 A definitive recommendation regarding the most effective treatment for chronic stroke patients 1 BWS plus FNS-IM or 2 BWS alone
RESEARCH OBJECTIVES
1 Build stimulators and electrodes
2 Obtain measures pre and post intervention for the two groups FNS-IM BWS and BWS alone to detect gains in a gait pattern b safety c functional capability and d quality of life
3 Analyze data for the group receiving FNS-IM BWS in order to test
Hypothesis I
4 Produce therapy protocols for FNS-IM and BWS intervention and treatment progression
5 Test Hypothesis II by comparing the two treatment groups BWS vs BWS FNS-IM
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