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Procedure

Ischemic Conditioning for Stroke

N/A

Recruiting

Led By Sangeetha Madhavan, PT, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Residual hemiparetic gait deficits (e.g., abnormal gait pattern)

Be older than 18 years old

Must not have

Other neurological disorders that may interfere with motor function

Botulinum toxin (Botox) treatments to the lower limb within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during each real and sham ischemic conditioning session, pain scores will be reported for each participant during intervals of blow flow restriction and reperfusion through study completion, an average of 1 year.

Summary

This trial aims to test if blood flow restriction, known as ischemic conditioning, can be used to improve walking ability in stroke patients. The researchers want to see if this technique can change brain activity in

Who is the study for?

This trial is for individuals aged 18-35 who have had a stroke. It's not open to those with other neurological impairments. Participants will undergo sessions of ischemic conditioning and aerobic exercise to see if these can improve their walking ability after the stroke.

What is being tested?

The study tests whether restricting blood flow using a cuff on the thigh (ischemic conditioning) or doing aerobic exercise can help change brain activity and enhance motor skills like strength, control, and speed in people recovering from a stroke.

What are the potential side effects?

Possible side effects may include discomfort from the pressure cuff used during ischemic conditioning or general fatigue post-exercise. The impact on each individual could vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have difficulty walking due to partial paralysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition that affects my movement.

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I have not had Botox in my legs in the last 6 months.

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I have been diagnosed with severe kidney or liver disease.

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I have had skull abnormalities or fractures.

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I have severe osteoporosis.

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I have a history of seizures or epilepsy.

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I have high blood pressure that isn't well-controlled.

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I have a history of blood vessel or blood disease.

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I cannot undergo TMS or IC due to health reasons.

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I do not have ongoing infections or unhealed sores that could affect test procedures.

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I have a history of blood clots, including in my veins.

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I don't have blood clots, open wounds, or nerve damage in my leg.

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I have had surgery for blood vessel grafts in my legs.

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I am not taking any medication that affects brain activity or increases seizure risk.

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I often have headaches for no clear reason.

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I have lesions in my brainstem or cerebellum.

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I don't have any untreated heart, lung, or high blood pressure conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during each real and sham ischemic conditioning session, pain scores will be reported for each participant during intervals of blow flow restriction and reperfusion through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during each real and sham ischemic conditioning session, pain scores will be reported for each participant during intervals of blow flow restriction and reperfusion through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during each real and sham ischemic conditioning session, pain scores will be reported for each participant during intervals of blow flow restriction and reperfusion through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ankle motor control

Change in corticomotor excitability

Change in lower limb strength

+1 more

Secondary study objectives

Numerical Rating Scale (NRS) for Pain

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ischemic ConditioningExperimental Treatment1 Intervention

While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.

Group II: Sham Ischemic ConditioningPlacebo Group1 Intervention

While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.

0 / 18Eligibility criteria met