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Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

Primary Purpose

Stroke Rehabilitation, Ischemic Preconditioning, Physical and Rehabilitation Medicine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Preconditioning
Sham
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ischemic Preconditioning

Sham

Arm Description

Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.

Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.

Outcomes

Primary Outcome Measures

Change in Knee Extensor Strength

Secondary Outcome Measures

Change in Walking Speed

Full Information

First Posted
January 3, 2017
Last Updated
August 23, 2023
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
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1. Study Identification

Unique Protocol Identification Number
NCT03023150
Brief Title
Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert
Official Title
Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2023 (Actual)
Study Completion Date
August 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Marquette University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation, Ischemic Preconditioning, Physical and Rehabilitation Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic Preconditioning
Arm Type
Experimental
Arm Description
Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Intervention Type
Other
Intervention Name(s)
Ischemic Preconditioning
Intervention Type
Other
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
Change in Knee Extensor Strength
Time Frame
Admission into study and within 3 days of Discharge from Froedtert Hospital
Secondary Outcome Measure Information:
Title
Change in Walking Speed
Time Frame
Admission into study and within 3 days of Discharge from Froedtert Hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

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