Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in the Timed Up-and-Go test score (s)
研究概览
简要总结
This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of usability and effectiveness of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Hip Arthroplasty (THA).
Patients admitted to Presidio San Camillo after a THA surgery are randomly allocated to the control arm or the experimental arm with a 1:1 ratio. Participants in both arms receive inpatient care and rehabilitation for 2 weeks at San Camillo. At discharge, they are prescribed with the same daily plan of 5 exercises for autonomous home-based rehabilitation. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.
Outcomes assessment is performed at San Camillo admission (baseline), at San Camillo discharge (2 weeks from baseline) and 3 weeks after San Camillo discharge (5 weeks from baseline).
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)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and accept the clinical study procedure and to sign an informed consent form
- •Good familiarity with the Italian language
- •Good predisposition to the use of technology or availability of a caregiver providing technological support to the patient
- •Availability to move to the Rehabilitation Center for control visits
排除标准
- •Age <60 or >80 years
- •Admission after THA revision surgery
- •Contralateral hip osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
- •Aphasia, dementia, or psychiatric comorbidity interfering with communication or adherence to the rehabilitation process
- •Respiratory, cardiac, metabolic, or other condition limiting patient mobility and ability to comply with a rehabilitation program
- •Major medical complications occurring after surgery that prevented the discharge of the patient within 10 days after the surgery
- •Body mass index >35kg/m2
结局指标
主要结局
Change in the Timed Up-and-Go test score (s)
时间窗: Baseline, 2 weeks and 5 weeks from baseline
The TUG test outcome is the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down as the score.
次要结局
- Change in Hip Extension Range of Motion (º)(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Hip Flexion Range of Motion (º)(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Hip Abduction Range of Motion (º)(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Abduction Strength (kg)(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Quadriceps Strength (kg)(Baseline, 2 weeks and 5 weeks from baseline)
- Satisfaction with ReHub: System Usability Scale(5 weeks from baseline)
- Change in Extension Strength (kg)(Baseline, 2 weeks and 5 weeks from baseline)
- Global Rating Of Change(5 weeks from baseline)
- Change in Self-Reported Pain Level in Movement: Numerical Rating Scale(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Hip disability and Osteoarthritis Outcome Score (HOOS)(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Functional Independence Measure (FIM) score(Baseline, 2 weeks and 5 weeks from baseline)
- Change in Self-Reported Pain Level at Rest: Numerical Rating Scale(Baseline, 2 weeks and 5 weeks from baseline)