Ischemic Conditioning Improves Walking Function Post Stroke

NCT04038697 | Completed

• 1 other identifier: HR-1812027206
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Stroke; Stroke, Cardiovascular

Keywords

Stroke; Rehabilitation; Ischemic Conditioning; Treadmill Training

Outcome Measures

Primary Outcomes (1)

• Self Selected Walking Speed

  We will measure how fast participants walk during the 10 meter walk test.

  Change from baseline to 4 weeks.

Secondary Outcomes (4)

• Knee Extensor Leg Strength

  Change from baseline to 4 weeks.

• Knee Extensor Fatigability

  Change from baseline to 4 weeks.

• Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery

  Change from baseline to 4 weeks.

• Peak Oxygen Consumption

  Change from baseline to 4 weeks.

Other Outcomes (14)

• Six minute walk test

  Change from baseline to 4 weeks.

• Lower Extremity Fugl Meyer

  Change from baseline to 4 weeks.

• Manual Muscle Test

  Change from baseline to 4 weeks.

Study Arms (4)

Ischemic Conditioning + Treadmill Training

EXPERIMENTAL

Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.

Procedure: Ischemic Conditioning; Procedure: Treadmill Training

Ischemic Conditioning Sham + Treadmill Training

PLACEBO COMPARATOR

Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.

Procedure: Ischemic Conditioning Sham; Procedure: Treadmill Training

Ischemic Conditioning Only

ACTIVE COMPARATOR

Study participants with prior history of stroke will receive only ischemic conditioning.

Procedure: Ischemic Conditioning

Healthy Control - Ischemic Conditioning + Treadmill Training

ACTIVE COMPARATOR

Healthy control participants will receive both ischemic conditioning and treadmill training.

Procedure: Ischemic Conditioning; Procedure: Treadmill Training

Interventions

Ischemic Conditioning PROCEDURE

Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants assigned to the IC Only and IC + Treadmill Training groups will undergo twelve sessions of ischemic conditioning over a four-week period.

Healthy Control - Ischemic Conditioning + Treadmill Training; Ischemic Conditioning + Treadmill Training; Ischemic Conditioning Only

Ischemic Conditioning Sham PROCEDURE

Ischemic conditioning sham consists of the same setup as ischemic conditioning, which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 10 mmHg for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. 10 mmHg is a sufficient inflation pressure for study participants to perceive some cuff tightness, but is not high enough to occlude blood flow. In our study, participants assigned to the IC Sham + Treadmill Training groups will undergo twelve sessions of ischemic conditioning sham over a four-week period.

Ischemic Conditioning Sham + Treadmill Training

Treadmill Training PROCEDURE

Participants will perform 3 treadmill training sessions/week for a 4 week period (12 sessions total). Treadmill training will immediately follow IC or IC Sham. Personnel performing the treadmill training will be blinded to the IC treatment group. Subjects will walk on a treadmill for six, 5-minute intervals. Walking speed will be continuously adjusted to maintain heart rate between 50% and 60% of age-adjusted heart rate reserve to minimize the confounder of intensity. If individuals cannot walk at 80% of their overground self-selected walking speed, for 5 minutes, they will be assisted into a body weight support harness. Body weight support will be adjusted (up to 50%) such that individuals can walk at 80% of their over ground walking speed for five minutes and adjusted accordingly throughout the session. Participants assigned to the Treadmill + IC and Treadmill + IC Sham groups will receive Treadmill Training.

Healthy Control - Ischemic Conditioning + Treadmill Training; Ischemic Conditioning + Treadmill Training; Ischemic Conditioning Sham + Treadmill Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be ≥ 1 year post diagnosis of a unilateral, cortical stroke and have residual lower extremity paresis
• be between the ages of 18-85
• be able to give informed consent
• walk slower than normative values based on age and sex

You may not qualify if:

• history of deep vein thrombosis or any condition in which transient ischemia to the lower extremity is contraindicated
• inability to follow 2 step commands
• chronic low back or hip pain
• history of substance abuse
• history of head trauma
• comorbid neurological disorder
• any uncontrolled medical condition
• pacemaker
• any condition where fatiguing contractions or resisted leg contractions are contraindicated
• inability to walk for 5 minute bouts on a treadmill with a harness supporting up to 50% of the body weight at 80% of over-ground self-selected walking speed.
• be between ages of 18-85
• be able to give informed consent
• Those listed above for stroke survivors
• History of Stroke

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator

Study Sites (2)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Myocardial Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 31, 2019
• Study Start: December 20, 2018
• Primary Completion: December 16, 2025
• Study Completion: January 9, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)