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Completed

NCT Number: NCT03095755

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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marquette University

Milwaukee, Wisconsin, 53233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Leg Muscle Strength

    Time frame: Within 1 year of admission into the study

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

Secondary outcomes

  1. Leg Muscle Fatigue

    Time frame: Within 1 year of admission into the study

    Duration the leg muscles can sustain contraction to a load level equal to 30% of a maximum voluntary contraction. Measurement units will be seconds the contraction can be held, as assessed using a Biodex Dynamometer.

  2. Brachial Artery Flow Mediated Dilation

    Time frame: Within 1 year of admission into the study

    Percent dilation of the brachial artery

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Marquette University

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2017
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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