Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

NCT ID: NCT03023150

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2023-08-31

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.

Conditions

Stroke Rehabilitation; Ischemic Preconditioning; Physical and Rehabilitation Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ischemic Preconditioning

Intervention Type: OTHER

Sham

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

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

Interventions

Ischemic Preconditioning

Intervention Type: OTHER

Sham

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Matthew J. Durand

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00027450

Identifier Type: -

Identifier Source: org_study_id