NCT06908564

Balance Rehabilitation Based on Serious Games

Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: IRCCS San Raffaele Roma · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hip Replacement, Total

Interventions

Type	Name	Description
DEVICE	Experimental: Interactive balance rehabilitation based on serious games.	The intervention of the Experimental Group consists of 30 minutes (16 sessions, 4 days/week, for 4 weeks) of balance rehabilitation exercises using non-immersive virtual reality through the OAK device (Khymeia Group, Italy). The system includes exercises that require the patient to reach visual targets by shifting their Center of Pressure (COP). The exercises are categorized based on the direction of COP displacement and can be performed with increasing difficulty, as determined by the physiotherapist during the rehabilitation process.
OTHER	Active Comparator: conventional balance rehabilitation without the use of technological devices.	Intervention of the Control Group (CG) consists of 30 minutes (4 days/week, for 4 weeks) of conventional balance rehabilitation treatments without the use of technological devices. The motor exercises will focus on the rehabilitation of balance, the trunk, and the lower limbs and will be carried out with a physiotherapist who will tailor the treatment according to the patient's characteristics and needs. Primary attention will be given to recovering trunk control and seated posture. This phase will focus on restoring and maintaining muscle trophism in the anterior and posterior kinetic chains of the thigh and lower leg, as well as the hip's range of motion, through isometric exercises and gentle joint mobilizations while adhering to anti-dislocation guidelines. The process will continue with the reacquisition of the upright stance, emphasizing proprioceptive, coordination, and balance abilities. Once the upright position is stabilized, gait re-education will be introduced.

Timeline

• Start date: 2023-06-23
• Primary completion: 2025-12-31
• Completion: 2026-03-23
• First posted: 2025-04-03
• Last updated: 2025-04-09

Locations

2 sites across 1 country: Italy