Actively Recruiting
Efficacy of Balance Rehabilitation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study
Led by IRCCS San Raffaele Roma · Updated on 2025-04-09
20
Participants Needed
2
Research Sites
11 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele Roma
Lead Sponsor
M
Ministero della Salute, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of new technologies, especially serious games, on the rehabilitation process for patients who have undergone total hip arthroplasty (THA). This surgery is common worldwide and aims to reduce pain and improve function and quality of life. The study focuses on whether a balance rehabilitation program using serious games can better support balance recovery compared to conventional treatments in these patients. The study compares two groups: an Experimental Group performing 30-minute balance exercises using non-immersive virtual reality with the OAK device four days a week for four weeks, and a Control Group receiving conventional balance rehabilitation without technological devices on the same schedule. The serious games involve reaching visual targets by shifting balance, with difficulty adjusted by therapists. Conventional therapy focuses on trunk control, muscle strength, and gait re-education led by a physiotherapist. Participants will be assessed at the start and after 30 days of treatment using tests like the Time Up and Go Test and others evaluating walking, balance confidence, pain levels, and joint function. Additional follow-up occurs at three months to monitor longer-term effects. The study involves physical exams, questionnaires, and monitoring to measure rehabilitation progress, safety, and effectiveness over the study period.
CONDITIONS
Brief Title
Balance Rehabilitation Based on Serious Games
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Undergoing first elective hip arthroplasty
- Cognitive ability to understand and perform the exercises
- Ability to sign informed consent
You will not qualify if you...
- Unable to adhere to the exercise program due to poor compliance
- Previous contralateral hip arthroplasty
- Surgical wound complications
- Severe cognitive, linguistic, or visual impairments
- Conditions interfering with study participation or safety
- Diagnosis of epilepsy
- Presence of implanted cardiac pacemakers
- Lack of signed informed consent for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo balance rehabilitation exercises either using non-immersive virtual reality serious games with the OAK device or conventional balance rehabilitation without technological devices.
16 sessions (4 days/week, 30 minutes each)
Duration - Up to 3 months after treatment
Participants are assessed up to 3 months after treatment to evaluate longer-term outcomes including pain, balance confidence, and functional mobility.
2 visits (at treatment end and 3 months after treatment)
Trial Site Locations
Total: 2 locations
1
IRCCS San Raffaele Roma
Rome, Italy, Italy, 00163
Actively Recruiting
2
Casa di Cura San Raffaele Sulmona
Sulmona, Italy, Italy, 67039
Actively Recruiting
Research Team
D
Dr. Sanaz Pournajaf, DPT
D
Dr. Carlotta Maria Manzia, DT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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