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临床试验/NCT06733480
NCT06733480招募中不适用

Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 499 人开始时间: 2025年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
499
试验地点
1
主要终点
Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score

研究概览

简要总结

Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the procedure. The purpose of this research is to investigate the effectiveness of Band Connect, a connected health platform, in enhancing compliance with home exercise programs among patients undergoing physical therapy. This study aims to evaluate the implications of increased compliance on improving patient engagement and increasing satisfaction for both patients and clinicians. Additionally, the study will analyze the economic implications of implementing Band Connect's hybrid care model on driving increased revenue per patient.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range: from 18 to 89 years old
  • •Surgery performed by Dr. Robert Gillespie and will be undergoing post-op physical therapy rehabilitation at University Hospitals
  • •Patients undergoing primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA)
  • •Patients undergoing primary rotator cuff repair
  • •Prescribed outpatient physical therapy for post-operative rehabilitation
  • •Chart Review Inclusion Criteria:
  • •Age range: from 18 to 89 years old
  • •Surgery performed by Dr. Robert Gillespie who underwent post-op physical therapy rehabilitation at University Hospitals
  • •Patients who underwent primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA)
  • •Patients who underwent primary rotator cuff repair
  • •Prescribed outpatient physical therapy for post-operative rehabilitation

排除标准

  • •Patients undergoing hemiarthroplasty or revision TSA
  • •Patients undergoing revision rotator cuff repair
  • •TSA performed for proximal humerus fractures
  • •Length of stay in hospital following shoulder surgery greater than 3 days
  • •Shoulder injuries related to workers compensation or involved in any pending litigation
  • •Pregnant individuals
  • •Chart Review Exclusion Criteria:
  • •Patients undergoing hemiarthroplasty or revision TSA
  • •Patients undergoing revision rotator cuff repair
  • •TSA performed for proximal humerus fractures
  • •Length of stay in hospital following shoulder surgery greater than 3 days
  • •Shoulder injuries related to workers compensation or involved in any pending litigation
  • •Pregnant individuals

研究组 & 干预措施

Group 1 Band Connect

Experimental

Patients in group 1 will be set up with the Band Connect platform and build their treatment plan at the first in-clinic visit.

干预措施: Band Connect (Device)

Group 2 Standard Care

No Intervention

Group 2 will consist of retrospective chart review to as act a control group. Charts will be pulled from 1/1/2019-12/31/2023.

结局指标

主要结局

Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score

时间窗: Up to 6 months

Scored out of 100, with higher scores indicating greater satisfaction

Number of adverse events as measured by medical record review.

时间窗: Up to 6 months

Number of physical therapy visits as measured by medical record review.

时间窗: Up to 6 months

Number of home exercise programs completed as measured by medical record review.

时间窗: Up to 6 months

Number of in clinic visits as measured by medical record review.

时间窗: Up to 6 months

Number of patients who were able to return to work

时间窗: Up to 6 months

This will be asked as a Yes/No question

Time to return to work measured in weeks

时间窗: Up to 6 months

Number of patients who returned to sports

时间窗: Up to 6 months

This will be asked as a Yes/No question

Change in pain as measured by the Visual Analog Scale

时间窗: Baseline, 1 month, 3 months, 6 months

The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Active range of motion measured in degrees

时间窗: Up to 6 months

Passive range of motion measured in degrees

时间窗: Up to 6 months

Strength will be measured on a scale of 0-5

时间窗: Up to 6 months

Strength scale: * 0: no visible or palpable contraction * 1: visible or palpable contraction without motion * 2: full range of motion, gravity eliminated * 3: full range of motion against gravity * 4: full range of motion against gravity, moderate resistance * 5: full range of motion against gravity, maximal resistance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert J. Gillespie

Vice Chair of Education

University Hospitals Cleveland Medical Center

研究点 (1)

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