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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095755
• Other study ID #: PRO00019103
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: April 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Ischemic Conditioning
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
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.

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg Muscle Strength	Maximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.	Within 1 year of admission into the study
Secondary	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.	Within 1 year of admission into the study
Secondary	Brachial Artery Flow Mediated Dilation	Percent dilation of the brachial artery	Within 1 year of admission into the study