Rehabilitation using serious games for hip replacement patients
Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study
This study is testing whether using interactive video games for balance rehab can help people recover better after hip replacement surgery compared to regular rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 2 sites (Rome, Italy and 1 other locations) |
| Trial ID | NCT06908564 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a balance rehabilitation program based on serious games for patients who have undergone total hip arthroplasty, comparing it to conventional rehabilitation methods. The program utilizes interactive video games to enhance patient engagement and motivation during recovery, potentially leading to improved balance and rehabilitation outcomes. Participants will be monitored using sensors and biosensors to personalize their treatment and track progress. The study aims to fill the gap in literature regarding the safety and effectiveness of exergames in orthopedic rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing their first elective hip arthroplasty and can understand and follow the rehabilitation exercises.
Not a fit: Patients with severe cognitive, linguistic, or visual impairments, or those unable to adhere to the exercise program may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve balance recovery and overall rehabilitation outcomes for hip replacement patients.
How similar studies have performed: While there is limited literature on the effectiveness of exergames in orthopedic rehabilitation, some studies have shown moderate benefits from technology-assisted rehabilitation approaches.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, Italy and 1 other locations
- IRCCS San Raffaele Roma — Rome, Italy, Italy (Recruiting)
- Casa di Cura San Raffaele Sulmona — Sulmona, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Prof. Marco Franceschini, MD — IRCCS San Raffaele Roma
- Study coordinator: Dr. Sanaz Pournajaf, DPT
- Email: sanaz.pournajaf@sanraffaele.it
- Phone: +390652252405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.