Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243919
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2005-10-24
Brief Title:
Locomotor Experience Applied Post Stroke Trial
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Locomotor Experience Applied Post Stroke LEAPS Trial
Status:
COMPLETED
Status Verified Date:
2012-12
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:
LEAPS
Brief Summary:
The purpose of this study is to compare two different treatments to improve walking after stroke or post-stroke
Detailed Description:
The impact of stroke on walking is significant with only 37 percent of stroke survivors able to walk after the first week after stroke or post-stroke Even among those who achieve independent ambulation significant residual deficits persist in balance and gait speed with a 73 percent incidence of falls among individuals with mild to moderate impairment 6 months post-stroke Body weight supported treadmill training is one therapeutic method for locomotor training that is rapidly being adopted into physical rehabilitation to improve walking after stroke
The purpose of this multi-center randomized controlled study is to compare two different treatments to improve walking after stroke The two treatments are 1 a training program that includes use of a body weight support system and a treadmill to practice walking and 2 a physical therapist monitored exercise program to work on general conditioning and strengthening in the patients home In addition investigators will determine the best time to provide training after a stroke and if the training is beneficial for mild moderate or severe cases of stroke
Four hundred subjects will be recruited from five facilities in Florida and California Screening and subject recruitment will take place within 45 days post-stroke All stroke patients will be screened to determine eligibility for the study Eligible subjects will be followed for 2 months post-stroke At that time those who are eligible for enrollment and who consent to participate will undergo an exercise tolerance test and baseline assessment Following this evaluation participants will be randomized into one of three groups according to the severity of their locomotor impairment early locomotor late locomotor or early home exercise
The early locomotor training group will begin the locomotor training program immediately 2 months post stroke The locomotor training program is an out-patient program of locomotor training for 36 sessions 3 times per week using a body weight support system and stepping on a treadmill The late locomotor training group will begin locomotor training at 6 months post-stroke Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning immediately 2 months post stroke
The purpose of this multi-center randomized controlled study is to compare two different treatments to improve walking after stroke The two treatments are 1 a training program that includes use of a body weight support system and a treadmill to practice walking and 2 a physical therapist monitored exercise program to work on general conditioning and strengthening in the patients home In addition investigators will determine the best time to provide training after a stroke and if the training is beneficial for mild moderate or severe cases of stroke
Four hundred subjects will be recruited from five facilities in Florida and California Screening and subject recruitment will take place within 45 days post-stroke All stroke patients will be screened to determine eligibility for the study Eligible subjects will be followed for 2 months post-stroke At that time those who are eligible for enrollment and who consent to participate will undergo an exercise tolerance test and baseline assessment Following this evaluation participants will be randomized into one of three groups according to the severity of their locomotor impairment early locomotor late locomotor or early home exercise
The early locomotor training group will begin the locomotor training program immediately 2 months post stroke The locomotor training program is an out-patient program of locomotor training for 36 sessions 3 times per week using a body weight support system and stepping on a treadmill The late locomotor training group will begin locomotor training at 6 months post-stroke Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning immediately 2 months post stroke
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS050506 | NIH | None | httpsreporternihgovquickSearchR01NS050506 |