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

Medical College of Wisconsin

Status: Completed

Conditions: Stroke

Treatments: Other: Sham; Other: Ischemic Conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03095755

PRO00019103

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups

Ischemic Conditioning

Experimental group

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.

Treatment:

Other: Ischemic Conditioning

Sham

Sham Comparator group

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.

Treatment:

Other: Sham