Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-07-29
2025-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Conventional rehabilitation plus blood flow restriction (BFR) therapy
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Additionally, a BFR Cuff will be applied during physical therapy.
Blood Flow Restriction (BFR) Therapy
BFR Cuff will be applied to the most proximal portion of the affected arm or leg, immediately before performing exercises during physical therapy. The cuff will remain on for the entire time while an exercise is performed and will be removed in between exercises while the subject rests.
Conventional rehabilitation
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
Physical Therapy
Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests
Interventions
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Blood Flow Restriction (BFR) Therapy
BFR Cuff will be applied to the most proximal portion of the affected arm or leg, immediately before performing exercises during physical therapy. The cuff will remain on for the entire time while an exercise is performed and will be removed in between exercises while the subject rests.
Physical Therapy
Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately. This will be facilitated by describing the reasons for withdrawal to the patient prior to initiating the study and ask patients and other providers to inform the investigators if there are any issues or concerns.
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Kelechi Okoroha, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-006791
Identifier Type: -
Identifier Source: org_study_id
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