Stroke RehabilitationNCT03023150
Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert
A study testing Ischemic Preconditioning in people with Stroke Rehabilitation and Ischemic Preconditioning, run by Medical College of Wisconsin at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke Rehabilitation, Ischemic Preconditioning, Physical and Rehabilitation Medicine
- What is being tested?
- Ischemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be between the ages of 40-80
- able to give informed consent.
- be < 6 months post diagnosis of unilateral cortical stroke and
- have residual leg paresis.
Who cannot join
- chronic low back or hip pain
- substance abuse
- head trauma with loss of conciousness in last 6 months
- neurodegenerative disorder
- participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
- participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
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- resting systolic blood pressure < 90mmHg (exclusion from nitro administration only, applies to outpatients only)
- any condition where knee extension contractions are contraindicated
- people who are unable to follow multi step commands.
- pregnancy (DXA scan exclusion only)
- history of major psychiatric disorder
- participant has had a myocardial infarction in the last year
- participant has stage II hypertension (BP>160/100)
- participant is unable to contract knee muscles
- participant is unable to sit upright for 2 hours
- participant has a resting heart rate >100 beats per minute
- history of multiple strokes
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation
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.
- Being tested
- Ischemic Preconditioning, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningOther
ShamOther
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioning | Experimental | Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Receives: Other: Ischemic Preconditioning |
| Sham | Sham comparator | Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Extensor Strength
Measured: Admission into study and within 3 days of Discharge from Froedtert Hospital
Secondary outcomes (1)
Change in Walking Speed
Measured: Admission into study and within 3 days of Discharge from Froedtert Hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionAug 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Matthew J. Durand, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023150
- Sponsor's protocol ID
- PRO00027450
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2017
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT03023150
- Acronym / sponsor ID
- PRO00027450
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- Oct 2016
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Preconditioning | Experimental | Other: Ischemic PreconditioningInflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. |
| Sham | Sham comparator | Other: ShamInflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be between the ages of 40-80
- able to give informed consent.
- be < 6 months post diagnosis of unilateral cortical stroke and
- have residual leg paresis.
Key exclusion criteria (17 listed)
- chronic low back or hip pain
- substance abuse
- head trauma with loss of conciousness in last 6 months
- neurodegenerative disorder
- participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic Preconditioning | Other | Ischemic Preconditioning |
| Sham | Other | Sham |
Primary outcome
Change in Knee Extensor Strength
Time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital
1 secondary outcome
Change in Walking Speed
Time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Preconditioning in people with Stroke Rehabilitation and Ischemic Preconditioning, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Extensor Strength (time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.