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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03095755
Enrollment
64
Registered
2017-03-30
Start date
2016-05-31
Completion date
2019-07-01
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

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.

OTHERSham

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.

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER
Marquette University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Leg Muscle StrengthWithin 1 year of admission into the studyMaximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.

Secondary

MeasureTime frameDescription
Leg Muscle FatigueWithin 1 year of admission into the studyDuration 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 DilationWithin 1 year of admission into the studyPercent dilation of the brachial artery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026