Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

August 23, 2023 updated by: Matthew J. Durand, Medical College of Wisconsin

Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. be between the ages of 40-80
  2. able to give informed consent.
  3. be < 6 months post diagnosis of unilateral cortical stroke and
  4. have residual leg paresis.

Exclusion Criteria:

  1. chronic low back or hip pain
  2. substance abuse
  3. head trauma with loss of conciousness in last 6 months
  4. neurodegenerative disorder
  5. participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
  6. participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
  7. resting systolic blood pressure < 90mmHg (exclusion from nitro administration only, applies to outpatients only)
  8. any condition where knee extension contractions are contraindicated
  9. people who are unable to follow multi step commands.
  10. pregnancy (DXA scan exclusion only)
  11. history of major psychiatric disorder
  12. participant has had a myocardial infarction in the last year
  13. participant has stage II hypertension (BP>160/100)
  14. participant is unable to contract knee muscles
  15. participant is unable to sit upright for 2 hours
  16. participant has a resting heart rate >100 beats per minute
  17. history of multiple strokes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ischemic Preconditioning
Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Other: Ischemic Preconditioning
Sham Comparator: Sham
Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Other: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Knee Extensor Strength
Time Frame: Admission into study and within 3 days of Discharge from Froedtert Hospital
Admission into study and within 3 days of Discharge from Froedtert Hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Walking Speed
Time Frame: Admission into study and within 3 days of Discharge from Froedtert Hospital
Admission into study and within 3 days of Discharge from Froedtert Hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Marquette University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimated)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00027450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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