Balance Rehabilitation Based on Serious Games (BERTHA)

IRCCS San Raffaele Roma

Status: Enrolling

Conditions: Hip Replacement, Total

Treatments: Other: Active Comparator: conventional balance rehabilitation without the use of technological devices.; Device: Experimental: Interactive balance rehabilitation based on serious games.

Study type: Interventional

Funder types: Other

Identifiers

NCT06908564

RP 23/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

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).

Treatment:

Device: Experimental: Interactive balance rehabilitation based on serious games.

Active comparator (CG)

Active Comparator group

Description:

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.

Treatment:

Other: Active Comparator: conventional balance rehabilitation without the use of technological devices.