Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedAugust 25, 2023
August 1, 2023
6.8 years
January 3, 2017
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Knee Extensor Strength
Admission into study and within 3 days of Discharge from Froedtert Hospital
Secondary Outcomes (1)
Change in Walking Speed
Admission into study and within 3 days of Discharge from Froedtert Hospital
Study Arms (2)
Ischemic Preconditioning
EXPERIMENTALInflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Sham
SHAM COMPARATORInflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- chronic low back or hip pain
- substance abuse
- head trauma with loss of conciousness in last 6 months
- neurodegenerative disorder
- any condition where knee extension contractions are contraindicated
- people who are unable to follow multi step commands.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- Marquette Universitycollaborator
Study Sites (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 18, 2017
Study Start
October 1, 2016
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
August 25, 2023
Record last verified: 2023-08