Ischemic Conditioning Improves Walking Function Post Stroke

Not Applicable

Recruiting

• Conditions: Stroke; Stroke, Ischemic; Stroke, Cardiovascular; Stroke Hemorrhagic
• Interventions: Procedure: Ischemic Conditioning; Procedure: Ischemic Conditioning Sham; Procedure: Treadmill Training

• Registration Number: NCT04038697
• Lead Sponsor: Medical College of Wisconsin

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 (3x/week; 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.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ischemic Conditioning + Treadmill Training	Ischemic Conditioning	Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.
Ischemic Conditioning Sham + Treadmill Training	Ischemic Conditioning Sham	Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
Healthy Control - Ischemic Conditioning + Treadmill Training	Treadmill Training	Healthy control participants will receive both ischemic conditioning and treadmill training.
Ischemic Conditioning Sham + Treadmill Training	Treadmill Training	Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
Ischemic Conditioning Only	Ischemic Conditioning	Study participants with prior history of stroke will receive only ischemic conditioning.
Healthy Control - Ischemic Conditioning + Treadmill Training	Ischemic Conditioning	Healthy control participants will receive both ischemic conditioning and treadmill training.
Ischemic Conditioning + Treadmill Training	Treadmill Training	Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.

Primary Outcome Measures

Name	Time	Method
Self Selected Walking Speed	Change from baseline to 4 weeks.	We will measure how fast participants walk during the 10 meter walk test.

Secondary Outcome Measures

Name	Time	Method
Knee Extensor Fatigability	Change from baseline to 4 weeks.	Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Knee Extensor Leg Strength	Change from baseline to 4 weeks.	Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Peak Oxygen Consumption	Change from baseline to 4 weeks.	Using a recumbent bicycle and metabolic cart, we will test whole body oxygen consumption during a graded exercise test
Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery	Change from baseline to 4 weeks.	Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention

Trial Locations

Locations (2)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Marquette University; 🇺🇸 Milwaukee, Wisconsin, United States