Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time Up and Go Test (TUG)
研究概览
简要总结
The effects of new technologies, particularly exergames, on the rehabilitation process of patients with hip arthroplasty have not yet been verified. For this reason, the aim of this study is to evaluate the effectiveness, in terms of balance recovery, of a balance rehabilitation program based on serious games in individuals with hip arthroplasty compared to conventional treatment.
详细描述
Total Hip Arthroplasty (THA) is one of the most commonly performed orthopedic surgeries worldwide, primarily aimed at reducing pain, improving function, and enhancing quality of life. Over the past decade, the rate of THA has increased by 30%, and it is projected to double by 2035. Rehabilitation after THA includes pain management, wound care, self-care, motor therapy, early mobilization, and complication prevention [iv, v, vi]. Active patient involvement in the rehabilitation process is increasingly recognized as essential for improving post-THA autonomy .
Exergames can enhance patient engagement and attention during treatment, potentially leading to better rehabilitation outcomes. The application of game design approaches in rehabilitation has gained popularity, offering more engaging treatments that boost patient motivation and understanding. Serious games, which are not primarily intended for entertainment, focus on specific therapeutic goals. In motor rehabilitation, exergames allow patients to perform physical exercises through video game interaction, often integrating sensors and biosensors that provide biofeedback and enable therapists to monitor progress and personalize treatment.
Despite their growing popularity, there is limited literature on the effectiveness and safety of exergames in orthopedic rehabilitation. A systematic review by Wang et al. found a moderate reduction in pain with technology-assisted rehabilitation (via tele-rehabilitation) in patients with hip and knee arthroplasty, but no significant effects on functional mobility. Research specifically on THA patients is scarce and of low quality. Byra et al. reported similar findings, indicating a lack of comprehensive evidence on the effectiveness of technological rehabilitation in THA patients, although preliminary results in pain management, posture training, and proprioception are promising.
The effects of new technologies, particularly exergames, on the rehabilitation of patients with hip arthroplasty remain unverified. This study aims to evaluate the effectiveness of a balance rehabilitation program based on serious games in individuals with hip arthroplasty compared to conventional treatment.
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
盲法说明
This study is assessor-blinded, meaning that the outcome assessors will be masked to group allocation to minimize bias in data collection and analysis. Other study personnel, including participants and intervention providers, will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •First elective hip arthroplasty;
- •Cognitive ability to understand and perform the exercises outlined in the protocol;
- •Ability to sign the informed consent.
排除标准
- •Unable to adhere to the exercise program due to poor compliance;
- •Previous contralateral hip arthroplasty;
- •Surgical wound complications;
- •Severe cognitive, linguistic, or visual impairments (inability to understand and follow the study procedures);
- •Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons;
- •Diagnosis of epilepsy;
- •Presence of implanted cardiac pacemakers;
- •Lack of signed informed consent for the study.
研究组 & 干预措施
Experimental Group (EG)
The Experimental Group (EG) perform 30 minutes (16 sessions, 4 days/week, for 4 weeks) of balance rehabilitation exercises using non-immersive virtual reality with the OAK device (Khymeia Group, Italy).
干预措施: Experimental: Interactive balance rehabilitation based on serious games. (Device)
Active comparator (CG)
Partecipants assigned to Control Group (CG) follow 30 minutes (4 days/week, for 4 weeks) of conventional rehabilitative treatments for balance without the use of technological devices.
干预措施: Active Comparator: conventional balance rehabilitation without the use of technological devices. (Other)
结局指标
主要结局
Time Up and Go Test (TUG)
时间窗: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
Time up and go test assess fall risk and measure the progress of balance, sit to stand and walking. Simple screening test that is a sensitive and specific measure of probability for falls among older adults. This test is intended to population affected by Parkinson's Disease, Multiple Sclerosis, Alzheimer's, Hip fracture, Total Knee Arthroplasty, Total Hip Replacement, Stroke and Huntington Disease. Materials needed consist in one chair with armrest, stopwatch and tape for mark 3 meters. Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position and stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Be sure to document the assistive device used. The score is calculated in seconds and high scores indicate an elevate risk of falling.
次要结局
- Cognitive Time Up and Go Test (TUG-C)(Day 0 (T0 - baseline), day 30 (T1 - After treatment).)
- Passive Range of Motion (p-ROM)(Day 0 (T0 - baseline), day 30 (T1 - After treatment).)
- Ten Meter Walking Test (10MWT)(Day 0 (T0 - baseline), day 30 (T1 - After treatment).)
- Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR).(Day 0 (T0 - baseline), day 30 (T1 - After treatment).)
- Medical Research Council Scale (MRC)(Day 0 (T0 - baseline), day 30 (T1 - After treatment).)
- Modified Barthel Index (mBI)(Day 0 (T0 - baseline), day 30 (T1 - After treatment).)
- Visual Analog Scale (VAS)(Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 months after treatment).)
- Activities-specific Balance Confidence scale (ABC).(Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 Months after treatment).)