Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06908564

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

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Follow-up

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

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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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