Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Ischemic Conditioning; Other: Sham

• Registration Number: NCT03095755
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The investigators will test whether an intervention called ischemic conditioning can improve paretic leg motor function in chronic stroke subjects.

Detailed Description

This study will study ischemic conditioning (IC) as an intervention to improve motor function post-stroke. IC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. Because IC targets three physiological systems which are all affected by stroke, the investigators hypothesize that repeated bouts of IC will result in improved motor function of the paretic leg.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-30
• Primary Completion: 2019-02-01
• Study Completion: 2019-07-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. be between the ages of 18-85
2. able to give informed consent
3. be ≥ 6 months post diagnosis of unilateral cortical stroke and
4. have residual leg paresis.

Exclusion Criteria

1. chronic low back or hip pain
2. substance abuse
3. head trauma in last 6 months
4. neurodegenerative disorder
5. any uncontrolled medical condition
6. any condition where knee extension contractions are contraindicated
7. people who are unable to follow multi step commands.
8. people who cannot walk ≥ 10 ft without physical assistance.
9. history of major psychiatric disorder
10. participant has had a myocardial infarction in the last year
11. participant has uncontrolled hypertension
12. participant is unable to contract knee muscles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ischemic Conditioning	Ischemic Conditioning	The investigators will perform ischemic conditioning on the paretic leg by inflating a blood pressure cuff to 225 mmHg to occlude blood flow to the leg for 5 minutes. This will be repeated for 5 cycles, with 5 minutes of rest between each cycle. The intervention will be performed for a maximum of 12 times within a 4 week period.
Sham	Sham	The investigators will perform sham ischemic conditioning on the paretic leg by inflating a blood pressure cuff to only 25 mmHg on the leg for 5 minutes. This will be repeated for 5 cycles, with 5 minutes of rest between each cycle. The intervention will be performed for a maximum of 12 times within a 4 week period.

Primary Outcome Measures

Name	Time	Method
Leg Muscle Strength	Within 1 year of admission into the study	Maximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.

Secondary Outcome Measures

Name	Time	Method
Brachial Artery Flow Mediated Dilation	Within 1 year of admission into the study	Percent dilation of the brachial artery
Leg Muscle Fatigue	Within 1 year of admission into the study	Duration the leg muscles can sustain contraction to a load level equal to 30% of a maximum voluntary contraction. Measurement units will be seconds the contraction can be held, as assessed using a Biodex Dynamometer.

Trial Locations

Locations (1)

Marquette University; 🇺🇸 Milwaukee, Wisconsin, United States