Clinical trial NCT06908564: Balance Rehabilitation Based on Serious Games
Official title: Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Replacement, Total
Keywords: Hip Arthroplasty Replacement
Lower Limb
Balance
Rehabilitation
Robotic-Assisted Therapy
Range Of Motion
Pain
Activity of Daily Living
Hip Replacement Total
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2025-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Time Up and Go Test (TUG)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
Secondary outcomes:
measure: Cognitive Time Up and Go Test (TUG-C)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Passive Range of Motion (p-ROM)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Ten Meter Walking Test (10MWT)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR).
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Medical Research Council Scale (MRC)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Modified Barthel Index (mBI)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Visual Analog Scale (VAS)
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 months after treatment).
measure: Activities-specific Balance Confidence scale (ABC).
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 Months after treatment).
Other outcomes:
measure: Bilateral thigh cytometry.
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
measure: Number of falls in the last 3 months.
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 months after treatment).
measure: Client satisfaction questionnaire .
timeFrame: Day 30 (T1 - After treatment).
measure: Posturography
timeFrame: Day 0 (T0 - baseline), day 30 (T1 - After treatment).
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
city: Sulmona
country: Italy
facility: Casa di Cura San Raffaele Sulmona
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Prof. Marco Franceschini, MD
role: STUDY_CHAIR
affiliation: IRCCS San Raffaele Roma
name: Prof. Marco Franceschini, MD
role: PRINCIPAL_INVESTIGATOR
References: