跳至主要内容
临床试验/NCT04682392
NCT04682392终止不适用

The Effects of Bone Health on Landing Mechanics on Patients Post ACL Reconstruction.

Candice Dunkin, MS, LAT, ATC2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
19
试验地点
2
主要终点
Leg Weight distribution landing on force plates

研究概览

简要总结

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: The BFR group will have decreased bone mineral loss and improved functional performance compared to control group.

详细描述

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 group will be tested with a Dexascan immediately post appointment confirming MRI findings of ACL tear and scheduling surgery. They will be then Scanned again at first therapy appointment within 24-48 hours of surgery. Then Dexascans will be done every 4 weeks until 28 weeks with a maximum of 9 scans. The scans will be completed on a normally scheduled rehabilitation session at the convenience of the radiology techs availability. The investigators will collect force plate measurements for squat symmetry at first 4-week assessment period, and then for landing symmetry every 4 weeks after that until 28 weeks.

Group 2 - ACL with BFR: 30 athletes with ACL tear that will receive BFR. This group will be selected in the same manner as the control group. They will be tested with a dexasan immediately post appointment confirming MRI findings of ACL tear and scheduling surgery. At the initial dexascan they will also be instructed in Blood flow restriction and do exercises with blood flow restriction to prepare for initial post-surgical visit. They will be then scanned again at first therapy appointment within 24-48 hours of surgery. Then Dexascans will be done every 4 weeks until 28 weeks with a maximum of 9 scans. The investigators will collect force plate measurements for squat symmetry at first 4-week assessment and then for landing symmetry every 4 weeks after that until 28 weeks.

The standard of care following ACL tear does not include Dexascan, force plate measurements, or blood flow restriction.

Independent Variable

1. Blood Flow Restrictions (BFR) Dependent Variable

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Athletes undergoing ACL reconstruction with or without meniscal pathology
  • MRI confirming ACL tear
  • Athletes ages 16-22

排除标准

  • 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

研究组 & 干预措施

Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group

Active Comparator

This group will use Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction for rehab.

干预措施: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group (Device)

Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group

Active Comparator

This group will use Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction for rehab.

干预措施: Standard ACL rehab (Other)

Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group

Active Comparator

Standard post operative ACL rehab without Blood flow restriction

干预措施: Standard ACL rehab (Other)

结局指标

主要结局

Leg Weight distribution landing on force plates

时间窗: week 28 post surgery

Athlete landing on force plates from and 18 inch height to compare loading / weight symmetry

次要结局

  • Bone mineral density(Week 28 post surgery)

研究者

发起方
Candice Dunkin, MS, LAT, ATC
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Candice Dunkin, MS, LAT, ATC

Director of Sports Medicine Parkview Sports Medicine

Parkview Health

研究点 (2)

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ACL Bone Health and Loading Study | 临床试验