Balance Rehabilitation Based on Serious Games

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2026-03-23

Brief Summary

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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.

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Detailed Description

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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

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Hip Replacement, Total

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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).

Group Type EXPERIMENTAL

Experimental: Interactive balance rehabilitation based on serious games.

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No