Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727930
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-02-06
Brief Title:
Variable Intensive Early Walking Post-Stroke - 2 VIEWS-2
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Variable Intensive Early Walking Post-Stroke -2 VIEWS-2
Status:
RECRUITING
Status Verified Date:
2024-05
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:
VIEWS-2
Brief Summary:
The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function community mobility and quality of life in patients with subacute 1-6 months post-stroke
Detailed Description:
The objective of this Phase II clinical trial is to identify how exercise training parameters particularly the specificity and intensity of stepping practice influence long-term mobility outcomes in patients with subacute stroke Previous work indicates these variables can influence the efficacy of training interventions in individuals without neurological injury with some data to support their utility in chronic stroke However studies that systematically assess the independent and combined effects of these principles in individuals early following stroke are sparse This critical research gap impedes clinical translation and current clinical practices remain adherent to traditional theories of rehabilitation including lower intensity interventions focused on underlying impairments Additional concerns of providing only high-intensity walking training revolve around the lack of attention toward movement quality will result in use of compensatory movement strategies that could be reinforced with repeated practice or that other risks of cardiovascular events should preclude high-intensity training Unfortunately there is little data to support these hypotheses and our studies suggest that application of these training parameters can strongly influence walking function as well as improve underlying impairments and improve gait kinematics Our approach is to characterize the effects of these training variables on recovery of locomotor function and quality as well as changes in impairments and other mobility tasks in patients early post-stroke in an effort to evaluate whether such training influences neurological recovery or whether patients utilize compensatory strategies In this 2x2 factorial RCT design Aim 1 of the study will characterize changes in mobility function associated with manipulation of specific and intensity of exercise interventions We will evaluate functional measures of gait speed and endurance spatiotemporal symmetry as well as measures of cardiopulmonary fitness We postulate that combined application of high-intensity task specific stepping practice will result in significantly greater increases in locomotor measures as compared to lower intensity or non-specific training paradigms In Aim 2 we will characterize the changes in impairments strength and other mobility tasks balance sit-to-stand transfers to determine whether stepping intervention can mitigate the major impairments underlying post-stroke impairments Quantitative measures of volitional strength will be the primary outcomes In Aim 3 we will characterize changes in community mobility and quality of life the later of which can inform us about cost-effectiveness Overall these results have potential implications on the delivery of effective exercise interventions in person with subacute stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 1R01HD108622 | NIH | None | httpsreporternihgovquickSearch1R01HD108622 |