Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Hip extensor strength
研究概览
简要总结
The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. SAGA is a well-known smart training technology company, and the investigators aim to partner with SAGA to use the BFR cuffs as the intervention method. The BFR cuff will be added to the current SOC for hip scope PT for the intervention group.
详细描述
Study Design and Research Methods i. Timeline: Treatment Protocol duration 12 weeks per participant beginning post operative day 1 following hip arthroscopy. PRO's will be collected out to 2 years post-surgery and standard rehabilitation will follow the 12-week intervention period for both the control and experimental group. Study will be a 2-year timeline in total.
ii. Procedures: Patients will be randomized to control group, who will undergo Steadman Hawkins Clinic Denver's standard hip arthroscopy rehab protocol (see appendix) or to the intervention group, who will undergo standard rehab protocol with addition of BFR. Subjects will be randomized 1:1 for intervention vs. control and controlled for gender assigned at birth.
iii. Frequency of BFR Training: 6 days per week phase 1, 3 days per week phases 2 and 3 iv. Frequency of clinic visits PT: 1 day per week v. Intervention Group: The following exercises outlined are the specific exercises that will be performed in addition to SOC. Only these exercises will involve the use of the BFR cuff.
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Phase 1 (post operative weeks 1-3)
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Dosage: 80% limb occlusion pressure (LOP). 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF.
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Frequency: All 3 exercises performed at least 6 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home
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Exercises:
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
- Single (Outcomes Assessor)
盲法说明
ACT's that collect data during visits will be blinded to what group the subject is in to prevent bias.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with labral tears, femoroacetabular impingement syndrome, loose bodies, ligamentum teres tears, and related intra-articular pathology to be treated with hip arthroscopy. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.
排除标准
- •bilateral hip surgeries to be performed within 12 weeks of each other, concomitant Peri-acetabular osteotomy, soft tissue repairs (hamstring, glute repairs), clinically diagnosed hip dysplasia, and the following BFR contraindications:
- •Deep Vein Thrombosis (DVT)
- •Pulmonary Embolism
- •Hemorrhagic/Thrombolytic Stroke
- •Clotting Disorders
- •Hemophilia or taking blood thinners
- •Pregnant or up to 6 months post-partum
- •Untreated Hypertension
- •Untreated Hypotension
- •Rhabdomyolysis or recent traumatic injury
结局指标
主要结局
Hip extensor strength
时间窗: 2 Years
1\. Strength of hip extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb. By 3 months post operatively, patients should be approaching 70% LSI in order to safely initiate impact activities such as jogging. Prior to discharge from therapy, patients should achieve at least 90% LSI per standard protocol.
次要结局
- Brief Resiliency Score(2 Years)
- LEFS(2 Years)
- PROMIS physical function(2 Years)
- i-HOT(2 Years)
- PROMIS pain(2 Years)
- range of motion (ROM)(2 Years)
- Tegner Activity Scale(2 Years)
- additional hip musculature strength(2 Years)
- single leg squat test(2 Years)