Does Virtual Reality Rehabilitation Added to Conventional Physiotherapy Improve Mobility, Balance, and Walking Assessed by Timed Up and Go in Patients With Total Hip Arthroplasty? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in the Timed Up and Go (TUG) score
研究概览
简要总结
This study aims to assess the efficacy of virtual reality through the Virtual Reality Rehabilitation System (VRRS) added to conventional rehabilitation versus conventional rehabilitation alone, for improving mobility, balance, and walking assessed by Timed Up and Go after primary Total Hip Arthroplasty.
详细描述
Following ethics approval by the ULSS 9, adults with THA (at 7 days after surgery), aged between 45 and 85 years old will be recruited for the study by the office worker of the rehabilitation hospital. Patients will be informed about the aim of the study and will sign the informed consent. Patients that decided to participate in the study will be randomized into two rehabilitation groups: experimental group and control group. Patients will be evaluated for reaching the baseline data from a physiotherapist blind to the aim of the study. Both groups (experimental and control) will receive the same clinical indications during hospitalization. Both groups will perform the same daily warm-up exercises supervised by physiotherapists external to the study investigation and will receive the same conventional-exercises program. In addition to this, each group will perform a second rehabilitation session with the virtual reality, using the Virtual Reality Rehabilitation System (VRRS), but in the control group, the sensors of VRRS will be not connected. The primary outcome will be the Timed Up and Go (TUG), the test used to assess mobility, balance, and walking.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 45-85 years
- •primary unilateral THA for hip osteoarthritis
- •signed informed consent
排除标准
- •people with clinically unstable serious diseases (e.g., heart or lung disease)
- •secondary THA replacement on the same side
- •hip replacement for neoplasm, proximal femoral fracture, or other causes out of osteoarthritis
- •contemporary bilateral replacement
- •presence of neurological diseases previous or following surgery
- •congenital abnormalities
- •patients with THA infection
- •psychotropic drugs assumption for pain management
结局指标
主要结局
Change in the Timed Up and Go (TUG) score
时间窗: baseline (7 days after surgery) and at discharge (28 days after surgery)
The TUG is a timed test used to assess mobility, balance, and walking. The subject must stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
次要结局
- Change in the 6 Minutes Walking Test (6MWT)(baseline (7 days after surgery) and at discharge (28 days after surgery))
- Change in the Numeric Rating Scale for pain (NPRS)(baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months)
- Change in the Numeric Rating of Patient Satisfaction with functional outcome(assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview))
- Change in the Short Form Health Survey 36 (SF-36)(baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview))
- The drugs assumption for pain management(assessed and reported at discharge (28 days after surgery))
- Change in the Hip Active Range of Motion(baseline (7 days after surgery) and at discharge (28 days after surgery))
- Change in the Strength of main muscles of the pelvis and thigh of the affected limb(baseline (7 days after surgery) and at discharge (28 days after surgery))
- Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)(baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview))
研究者
Mauro Crestani
Principal Investigator
Azienda Ulss 9 Scaligera