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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-07-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Ischemic Conditioning

Intervention Type OTHER

Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.

Interventions

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Ischemic Conditioning

Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.

Intervention Type OTHER

Sham

Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No