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

NCT03095755 | Completed

• 1 other identifier: PRO00019103
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Leg Muscle Strength

  Maximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.

  Within 1 year of admission into the study

Secondary Outcomes (2)

• Leg Muscle Fatigue

  Within 1 year of admission into the study

• Brachial Artery Flow Mediated Dilation

  Within 1 year of admission into the study

Study Arms (2)

Ischemic Conditioning

EXPERIMENTAL

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.

Other: Ischemic Conditioning

Sham

SHAM COMPARATOR

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.

Other: Sham

Interventions

Ischemic Conditioning 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.

Ischemic Conditioning

Sham 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.

Sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthew J Durand, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 30, 2017
• Study Start: May 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

US (1)