Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

Stroke Rehabilitation Clinical Trial

Official title:

Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023150
• Other study ID #: PRO00027450
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2023

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Preconditioning
• Physical and Rehabilitation Medicine
• Stroke
• Stroke Rehabilitation

Intervention

Other:
• Ischemic Preconditioning

• Sham

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	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	Change in Knee Extensor Strength		Admission into study and within 3 days of Discharge from Froedtert Hospital
Secondary	Change in Walking Speed		Admission into study and within 3 days of Discharge from Froedtert Hospital