Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

NCT ID: NCT05906602

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2025-12-01

Brief Summary

The goal of this clinical trial is to test ischemic conditioning (blood flow restriction) as a neuromodulatory technique to improve gait function in stroke. Neuromodulation is emerging as a promising adjunct strategy to facilitate changes in brain activity and improve motor behavior following a neurological injury such as stroke.

The main questions this trial aims to answer are:

• Can ischemic conditioning produce neuromodulatory changes in the lower limb primary motor cortex?
• Can ischemic conditioning be used as a neuromodulatory technique to improve strength, motor control, and gait speed in individuals with stroke when compared to sham ischemic conditioning?

Participants will take part in two sessions of ischemic conditioning where a cuff (similar to ones that measure blood pressure) will be placed around the thigh and inflated to one of two blood flow restriction pressures (real or sham). Each participant will experience measures of brain activity and motor behavior testing before and after both sessions (ischemic conditioning and sham ischemic conditioning).

Researchers will investigate ischemic conditioning as neuromodulation modality in stroke to see if ischemic conditioning can produce beneficial changes in brain activity and improvements on subsequent motor behavior tasks.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ischemic Conditioning

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 Type: EXPERIMENTAL

Real Ischemic Conditioning

Intervention Type: DEVICE

10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.

Sham Ischemic Conditioning

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.

Group Type: SHAM_COMPARATOR

Sham Ischemic Conditioning

Intervention Type: DEVICE

Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.

Interventions

Real Ischemic Conditioning

10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.

Intervention Type: DEVICE

Sham Ischemic Conditioning

Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.

Intervention Type: DEVICE

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)

• 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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Sangeetha Madhavan

Professor, Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sangeetha Madhavan, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2022-1620

Identifier Type: -

Identifier Source: org_study_id