Status:
RECRUITING
ACL Bone Health and Loading Study
Lead Sponsor:
Candice Dunkin, MS, LAT, ATC
Collaborating Sponsors:
Parkview Health
Conditions:
ACL Tear
Eligibility:
All Genders
16-22 years
Phase:
NA
Brief Summary
The purpose of this study is to look at the effects of bone density on lower extremity loading mechanics using Blood Flow Restriction (BFR) to provide the control group for bone health. Hypothesis: T...
Detailed Description
Group 1 - ACL without BFR : 30 athletes with ACL tears and will NOT do blood flow restriction (BFR). Random group allocation will be determined using envelopes for allocation concealment. The control ...
Eligibility Criteria
Inclusion
- Athletes undergoing ACL reconstruction with or without meniscal pathology
- MRI confirming ACL tear
- Athletes ages 16-22
Exclusion
- Any Cognitively impaired athletes
- Athletes not in age range of 16-22
- Athletes who have additional ligament repair or chondral repair.
- Athletes with any weight bearing restrictions greater than 4 weeks.
- Athletes with re-tears or history of contralateral ACL tears
- Athletes with any systemic neuromuscular or balance disorders will not be allowed
- Athletes who do not or are unable to provide consent or assent (with Parental consent).
- Pregnant women will be excluded.
- Athlete who has previously used Blood Flow Restriction
- Athletes who are unable or unwilling to complete all rehabilitation with Parkview Athletic Rehab at SportONE Parkview Fieldhouse
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04682392
Start Date
February 17 2021
End Date
January 1 2025
Last Update
January 22 2024
Active Locations (1)
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1
Parkview Athletic Rehab
Fort Wayne, Indiana, United States, 46805