Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037895
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-05-24
Brief Title:
Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training
Status:
COMPLETED
Status Verified Date:
2002-05
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:
This project seeks to overcome the reduced walking capability poor health status decreased functional capacity and sedentary lifestyle of stroke patients The specific objectives are to compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on a gait performance b functional outcomes c oxygen consumption during a seated task and finally d using Brain Motor Control Assessment to obtain neurophysiological characteristics as possible predictors of rehabilitation outcomes
Detailed Description:
Gait training is often delayed during the rehabilitation process because gait is thought to require preparation such as improved strength balance and coordination before the initiation of this more complex and demanding activity We propose a new approach to perform early gait training with acute stroke patients which consists of Supported Treadmill Ambulation Training STAT combined with conventional rehabilitation for achieving functional ambulation
Hypotheses This study will test three hypotheses
1 The STAT group will develop greater gait speed longer walking endurance and lower oxygen costs for walking as compared to stroke patients receiving regular rehabilitation care
2 The STAT group will develop better functional outcomes Functional Independence Measurement total scores and on the transfers and locomotion subscales as compared to stroke patients receiving regular rehabilitation care
3 The STAT group will develop higher submaximal oxygen consumption as measured on a bicycle ergometer test compared to stroke patients receiving regular rehabilitation care
Specific Objectives and Projected Timetable
Since stroke patients have reduced walking capability poor health status decreased functional capacity as well as a sedentary lifestyle the specific objectives of this project are
1 Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on gait performance
2 Compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on functional outcomes as defined by the Functional Independence Measure FIM
3 Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on the oxygen consumption during a seated exercise task
4 Explore whether neurophysiological characteristics using the Brain Motor Control Assessment BMCA predict rehabilitation outcomes
Timetable This 3-year project will compare the outcomes between two strategies of intervention during stroke rehabilitation Admission randomization testing intervention reevaluation and discharge will follow the time frame established by the facility while providing regular rehabilitation care for stroke patients On average the stroke rehabilitation process lasts two to three weeks
Hypotheses This study will test three hypotheses
1 The STAT group will develop greater gait speed longer walking endurance and lower oxygen costs for walking as compared to stroke patients receiving regular rehabilitation care
2 The STAT group will develop better functional outcomes Functional Independence Measurement total scores and on the transfers and locomotion subscales as compared to stroke patients receiving regular rehabilitation care
3 The STAT group will develop higher submaximal oxygen consumption as measured on a bicycle ergometer test compared to stroke patients receiving regular rehabilitation care
Specific Objectives and Projected Timetable
Since stroke patients have reduced walking capability poor health status decreased functional capacity as well as a sedentary lifestyle the specific objectives of this project are
1 Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on gait performance
2 Compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on functional outcomes as defined by the Functional Independence Measure FIM
3 Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on the oxygen consumption during a seated exercise task
4 Explore whether neurophysiological characteristics using the Brain Motor Control Assessment BMCA predict rehabilitation outcomes
Timetable This 3-year project will compare the outcomes between two strategies of intervention during stroke rehabilitation Admission randomization testing intervention reevaluation and discharge will follow the time frame established by the facility while providing regular rehabilitation care for stroke patients On average the stroke rehabilitation process lasts two to three weeks
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