Improving gait function in stroke patients using blood flow restriction techniques

Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

This study is testing if a technique that restricts blood flow can help stroke survivors improve their walking ability and regain better control of their movements.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05906602 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of ischemic conditioning, a technique involving blood flow restriction, on improving gait function in individuals who have experienced a stroke. Participants will undergo two sessions of ischemic conditioning, where a cuff will be applied to the thigh and inflated to either a real or sham pressure. The study aims to assess whether this intervention can induce neuromodulatory changes in the brain and enhance motor control, strength, and gait speed compared to a control group. Measurements of brain activity and motor behavior will be taken to evaluate the outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have experienced a stroke more than six months prior and have residual hemiparetic gait deficits.

Not a fit: Patients with significant cognitive impairments, other neurological disorders, or contraindications to the study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance mobility and quality of life for stroke survivors by improving their gait function.

How similar studies have performed: While the use of ischemic conditioning is a relatively novel approach, preliminary studies have shown promise in similar neuromodulatory techniques for improving motor function post-stroke.

Eligibility criteria

Inclusion Criteria:

* Single, stroke \> 6 months since onset
* Residual hemiparetic gait deficits (e.g., abnormal gait pattern)

Exclusion Criteria:

* Lesions affecting the brainstem or cerebellum
* Other neurological disorders that may interfere with motor function
* Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures
* Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE\<21)), which could impede the understanding of the purpose of procedures of the study
* Botulinum toxin (Botox) treatments to the lower limb within the past 6 months
* Pregnant women
* Contraindications to transcranial magnetic stimulation (TMS) or ischemic conditioning (IC) (Listed below)

TMS General Exclusion Criteria:

* Previous adverse reaction to TMS
* Skull abnormalities or fractures
* Concussion within the last 6 months
* Unexplained, recurring headaches
* Implanted cardiac pacemaker
* Metal implants in the head or face
* History of seizures or epilepsy
* Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
* Current pregnancy

IC General Exclusion Criteria:

* History of thrombosis (i.e., blood clots) including venous thrombosis or deep vein thrombosis (DVT).
* Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., open wounds in the leg, bruising, nerve damage, etc.)
* Peripheral arterial grafts in the lower extremity
* History of uncontrolled hypertension
* History of peripheral vascular disease or hematological disease

Where this trial is running

Chicago, Illinois

• University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Sangeetha Madhavan, PT, PhD — University of Illinois at Chicago
• Study coordinator: Mark Q Cummings, BS

Conditions Stroke