Balance Rehabilitation Based on Serious Games
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Interactive balance rehabilitation based on serious games., Active Comparator: conventional balance rehabilitation without the use of technological devices..
- Who it may be relevant to
- Registry conditions: Hip Replacement, Total. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study
Overview
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.
Interventions
- 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 physiothe - 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 w
Primary outcome measures
- Time Up and Go Test (TUG) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
Secondary outcome measures (8)
- Cognitive Time Up and Go Test (TUG-C) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
- Passive Range of Motion (p-ROM) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
- Ten Meter Walking Test (10MWT) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
- Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR). [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
- Medical Research Council Scale (MRC) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
- Modified Barthel Index (mBI) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).]
- Visual Analog Scale (VAS) [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 months after treatment).]
- Activities-specific Balance Confidence scale (ABC). [Time frame: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 Months after treatment).]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- IRCCS San Raffaele Roma — Rome
- Casa di Cura San Raffaele Sulmona — Sulmona
Identifiers
NCT: NCT06908564 · RP 23/08