Anterior Cruciate Ligament Reconstruction Clinical Trial
Official title:
Blood Flow Restriction Training Versus Standard Physical Therapy in Post-Operative and Post-Traumatic Rehabilitation Patients
NCT number | NCT02174770 |
Other study ID # | 395166 |
Secondary ID | 397709 |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | December 2017 |
Verified date | July 2020 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle at low resistance and minimal stress on the nearby joint. This novel resistance training has the potential to greatly improve extremity muscle strength gains for rehabilitation patients who are unable for medical reasons to perform high resistance exercise. Our study will explore this with specific rehabilitation populations: post-operative knee scopes, post-operative anterior cruciate ligament (ACL) reconstruction patients who have acute post-operative changes in thigh muscle function and chronic thigh weakness. The primary outcome is to achieve accelerated functional thigh recovery with outcome measures including thigh strength, validated questionnaires, and validated functional testing. Occlusion training can enhance rehab patients outcomes, reduce the cost of care, and improve the skills and efficiency of care providers.
Status | Terminated |
Enrollment | 10 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - One of the following: (1) s/p ACL reconstruction within the last three months prior to initiation of study training, (2) s/p knee arthroscopy within the last 2 weeks prior to initiation of study training, (3) S/p lower extremity trauma, unilateral with thigh weakness of at lest a 20% deficit compared to contralateral side and at least 6 months out from most recent trauma or surgery - Fluent in English and able to consent Exclusion Criteria: - Contralateral lower extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 5/10. - Pregnancy, verbal reporting - Recent history of deep vein thrombosis, within the 12 months or on active treatment - History of endothelial dysfunction, peripheral vascular disease, hypertension, diabetes, or people prone to capillary ruptures (bruising) (determined by verbal reporting by the patient) - Active Infection - Cancer (current diagnosis) |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Center for the Intrepid | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thigh Muscle Strength | 6 weeks |
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