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CompletedNCT03023150Updated Aug 25, 2023

Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

An interventional study of Ischemic Preconditioning and Sham in Stroke Rehabilitation, Ischemic Preconditioning and Physical and Rehabilitation Medicine, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Stroke Rehabilitation
  • Ischemic Preconditioning
  • Physical and Rehabilitation Medicine
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    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.

    Other: Ischemic Preconditioning

  • Sham comparator
    Sham

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

    Other: Sham

Interventions

  • OtherIschemic Preconditioning
  • OtherSham
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What researchers measure

Primary outcomes

  1. Change in Knee Extensor Strength

    Time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital

Secondary outcomes

  1. Change in Walking Speed

    Time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital

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Study locations

1 site
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03023150
Lead sponsor
Medical College of Wisconsin
Collaborators
Marquette University
Responsible party
Matthew J. Durand (Assistant Professor, Medical College of Wisconsin) — Principal investigator
First posted
Jan 18, 2017
Start date
Oct 2016
Primary completion
Aug 2023
Completion
Aug 2023
Last update
Aug 25, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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