跳至主要内容
临床试验/NCT07145957
NCT07145957招募中不适用

Does Undergoing a Prehabilitation Protocol Aimed at Optimizing Scapulothoracic Mobility and Strengthening Improve Internal Rotation After Reverse Shoulder Arthroplasty? A Randomized Controlled Trial

University of Florida1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年11月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Activities of Daily Living which require Internal Rotation (ADLIR) questionnaire

研究概览

简要总结

Difficulty with internal rotation (IR) after reverse shoulder arthroplasty (RSA) is common. Current rehabilitation protocols may not optimize IR. The investigator's objective is to assess the impact of prehabilitation focused on IR strengthening and mobility on RSA outcomes. The investigators will perform a prospective, randomized control trial to achieve the specific aim: assessing range of motion, strength, patient-reported outcomes, and activities of daily living requiring internal rotation between control and prehabilitation cohorts, with the prehabilitation patients receiving 6 weeks of treatment.

详细描述

Reverse total shoulder arthroplasty (RSA) provides excellent restoration of overhead motion and pain relief, with durability demonstrated up to 20-years postoperatively.6 However, despite advancements in surgical technique and implants, internal rotation (IR) remains challenging for many patients after RSA, with a recent study demonstrating as many as 63% of patients reporting significant difficulty or inability to perform some activities of daily living (ADLs) requiring IR.5

Many studies have been conducted to identify demographic, surgical, and implant-related predictors of improved IR after RSA. To date, the only consistent predictor of superior IR after RSA in the literature is more favorable preoperative IR. Nearly all interventions that have been evaluated to improve IR after RSA focus on glenohumeral relationships, such as repairing the subscapularis, increasing humeral component anteversion, and preventing impingement between the humeral polyethylene and the scapular neck. However, IR is a complex shoulder movement involving motion beyond the glenohumeral joint, including scapulothoracic, sternoclavicular, acromioclavicular, and truncal motion.

Studies evaluating shoulder girdle mechanics during abduction and forward elevation after RSA have shown increased dependence on scapulothoracic motion to compensate for less glenohumeral motion. Furthermore, Sulkar et al. performed bi-plane fluoroscopy to compare shoulder kinematics in low and high IR performers after RSA. Patients in the high rotation group had 7° greater scapular upward rotation and used a 15°-30° change in scapular tilt to perform IR in adduction, whereas tilt barely changed (<5°) in most patients in the low group. Interestingly, scapular notching occurred at similar rates in high and low performing cohorts, suggesting that scapular motion can compensate for bony impingement at the glenohumeral joint.

It stands to reason that a prehabilitation program focused on strengthening internal rotators and improving patients' neuromuscular control of the scapula may enable them to adapt more effectively to the altered biomechanics of RSA, and improve their ability to perform ADLs that require IR. Previous studies have demonstrated a moderate correlation between patients' preoperative shoulder strength and range of motion and their postoperative function. However, to date, no studies have attempted to determine whether preoperative improvement in shoulder mobility and strength might confer a durable improvement in shoulder function after RSA, particularly in IR. In the lower extremity, meta-analyses of randomized controlled trials of the total knee arthroplasty literature have found superior knee range of motion and sit-to-stand test performance in patients that underwent a prehabilitation program compared to controls.

The overarching objective is to assess the impact of prehabilitation IR strengthening and mobility on patients undergoing RSA. The specific aim of this study is to determine whether a preoperative rehabilitation program aimed at strengthening shoulder internal rotators and improving scapular mobility can improve patient-reported ability to perform IRADLs postoperatively, as evaluated using the Activities of Daily Living which require Internal Rotation (ADLIR) score.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 40-80
  • Undergoing primary RSA for glenohumeral osteoarthritis or rotator cuff arthropathy
  • Must be able to read and speak English
  • Willing and able to attend a monthly therapy session and perform exercises at home for a minimum of 6 weeks before surgery
  • Willing and able to participate in postoperative monitoring for a minimum of 2 years

排除标准

  • Patients under the age of 40 and over the age of
  • Diagnosis of septic shoulder, fracture, or fracture sequelae, or tumor pathology of the ipsilateral shoulder
  • Pre-existing hand, wrist, or elbow pathology that limits elbow flexion or extension, or forearm pronation or supination
  • Planned to undergo synchronous procedure of the involved extremity (e.g., synchronous RSA and carpal tunnel release)
  • Tendon transfer (e.g., Latissimus dorsi transfer) performed intraoperatively
  • Patients without access to phone or email communication for at least 2 years after treatment
  • Revision shoulder arthroplasty

结局指标

主要结局

Activities of Daily Living which require Internal Rotation (ADLIR) questionnaire

时间窗: 6-8 Weeks pre surgery, 2 Weeks pre surgery, and 12 weeks, 6 months, 1 year, 2 years post surgery

Activities of Daily Living questionnaire with a scale of 9 = worst, 100 = best Shoulder Internal Range of Motion Measurements with scoring scale: 0 = Thigh or less.1 = Hip. 2 = Buttocks, 3 =Sacrum, 4 = L4-L5, 5 = L1-L3, 6 = T12-T8, 7 = T7 or Higher

次要结局

  • Shoulder Internal Range of Motion Measurements(6-8 Weeks pre surgery, 2 Weeks pre surgery, and 12 weeks, 6 months, 1 year, 2 years post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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