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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Conditioning
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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. be between the ages of 18-85
  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 in last 6 months
  4. neurodegenerative disorder
  5. any uncontrolled medical condition
  6. any condition where knee extension contractions are contraindicated
  7. people who are unable to follow multi step commands.
  8. people who cannot walk ≥ 10 ft without physical assistance.
  9. history of major psychiatric disorder
  10. participant has had a myocardial infarction in the last year
  11. participant has uncontrolled hypertension
  12. participant is unable to contract knee muscles

Sites / Locations

  • Marquette University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ischemic Conditioning

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Leg Muscle Fatigue
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.
Brachial Artery Flow Mediated Dilation
Percent dilation of the brachial artery

Full Information

First Posted
March 23, 2017
Last Updated
April 10, 2020
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
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1. Study Identification

Unique Protocol Identification Number
NCT03095755
Brief Title
Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke
Official Title
Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ischemic Conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ischemic Conditioning
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
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 Outcome Measure Information:
Title
Leg Muscle Strength
Description
Maximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.
Time Frame
Within 1 year of admission into the study
Secondary Outcome Measure Information:
Title
Leg Muscle Fatigue
Description
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.
Time Frame
Within 1 year of admission into the study
Title
Brachial Artery Flow Mediated Dilation
Description
Percent dilation of the brachial artery
Time Frame
Within 1 year of admission into the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Durand, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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