Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04038697
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2019-07-25
Brief Title:
Ischemic Conditioning Improves Walking Function Post Stroke
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Ischemic Conditioning Improves Walking Function Post Stroke
Status:
RECRUITING
Status Verified Date:
2024-03
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 innovative study will address scientific and clinical areas relatively unexplored in chronic stroke that could lead to greater recovery of walking Ischemic Conditioning IC is a non-invasive simple procedure that improves motor function exercise performance and cardiovascular function in healthy controls but it has never been applied to the stroke population We postulate that IC enhances the recruitment of motoneurons and results in positive neural adaptations improves vascular endothelial function and peripheral blood flow and together these improvements result in an increased capacity to exercise and faster walking speed Future studies will examine the effects of IC and traditional therapy at different time points of recovery post stroke durability of IC molecular mechanisms of neural and cardiovascular adaptation and the efficacy compared with other adjuncts
Detailed Description:
This study will quantify the effects of Ischemic Conditioning and treadmill training on improvements in walking speed leg strength neuromuscular fatigability and the hyperemic blood flow response to muscle contractions and vascular endothelial function and aerobic exercise capacity A randomized control design will be used with three groups of chronic stroke survivors enrolled for four weeks of training 3xweek 12 sessions total The groups are IC Treadmill Training IC Sham Treadmill Training and IC only We will also enroll a group of age- and sex-matched healthy control subjects who will undergo IC Treadmill Training All Aims will be tested concurrently over a five-year period All studies will be performed in Cramer Hall at Marquette University in the Integrated Neural Engineering Rehabilitation Laboratories the Human Performance Assessment Core and the Physical Therapy Clinic
Randomization of stroke patients to the three intervention groups will be performed by using randomized block designs randomly chosen block sizes of 3 6 and 9 This number accounts for possible dropouts and the use of non- parametric methods
Randomization of stroke patients to the three intervention groups will be performed by using randomized block designs randomly chosen block sizes of 3 6 and 9 This number accounts for possible dropouts and the use of non- parametric methods
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