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Completed

NCT Number: NCT03023150

Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

This study will be the first study to use ischemic preconditioning (IPC) as an intervention to improve stroke rehabilitation. IPC 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 IPC targets three physiological systems which are all affected by stroke, we hypothesize that repeated bouts of IPC during the first days to months following stroke (when the majority of recovery occurs) will make traditional rehabilitation strategies more effective.

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Key information

Conditions

Stroke Rehabilitation Ischemic Preconditioning Physical and Rehabilitation Medicine

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

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 40-80
  • 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 with loss of conciousness in last 6 months
  • neurodegenerative disorder
  • participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
  • participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
  • resting systolic blood pressure < 90mmHg (exclusion from nitro administration only, applies to outpatients only)
  • any condition where knee extension contractions are contraindicated
  • people who are unable to follow multi step commands.
  • pregnancy (DXA scan exclusion only)
  • history of major psychiatric disorder
  • participant has had a myocardial infarction in the last year
  • participant has stage II hypertension (BP>160/100)
  • participant is unable to contract knee muscles
  • participant is unable to sit upright for 2 hours
  • participant has a resting heart rate >100 beats per minute
  • history of multiple strokes

Treatment and study plan

Ischemic Preconditioning

Other

SHAM

Other

Primary outcomes

  1. Change in Knee Extensor Strength

    Time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital

Secondary outcomes

  1. Change in Walking Speed

    Time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Marquette University

Registry information

Official study title

Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2017
Registry last updated
Aug 25, 2023

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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