Balance Rehabilitation Based on Serious Games

NCT06908564 | Recruiting DMC

• 1 other identifier: RP 23/08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Time Up and Go Test (TUG)

  Time up and go test assess fall risk and measure the progress of balance, sit to stand and walking. Simple screening test that is a sensitive and specific measure of probability for falls among older adults. This test is intended to population affected by Parkinson's Disease, Multiple Sclerosis, Alzheimer's, Hip fracture, Total Knee Arthroplasty, Total Hip Replacement, Stroke and Huntington Disease. Materials needed consist in one chair with armrest, stopwatch and tape for mark 3 meters. Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position and stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Be sure to document the assistive device used. The score is calculated in seconds and high scores indicate an elevate risk of falling.

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

Secondary Outcomes (8)

• Cognitive Time Up and Go Test (TUG-C)

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

• Passive Range of Motion (p-ROM)

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

• Ten Meter Walking Test (10MWT)

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

• Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR).

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

• Medical Research Council Scale (MRC)

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

Other Outcomes (4)

• Bilateral thigh cytometry.

  Day 0 (T0 - baseline), day 30 (T1 - After treatment).

• Number of falls in the last 3 months.

  Day 0 (T0 - baseline), day 30 (T1 - After treatment) and day 120 (T2 - 3 months after treatment).

• Client satisfaction questionnaire .

  Day 30 (T1 - After treatment).

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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).

Device: Experimental: Interactive balance rehabilitation based on serious games.

Active comparator (CG)

ACTIVE COMPARATOR

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.

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

Interventions

Experimental: Interactive balance rehabilitation based on serious games. 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.

Experimental Group (EG)

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

Active comparator (CG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ministero della Salute, Italy: collaborator

Study Sites (2)

IRCCS San Raffaele Roma

Rome, Italy, 00163, Italy

RECRUITING

Casa di Cura San Raffaele Sulmona

Sulmona, Italy, 67039, Italy

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Marco Franceschini, MD

  IRCCS San Raffaele Roma

  STUDY CHAIR

• Prof. Marco Franceschini, MD

  IRCCS San Raffaele Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Sanaz Pournajaf, DPT

CONTACT

+390652252405; sanaz.pournajaf@sanraffaele.it

Dr. Carlotta Maria Manzia, DT

CONTACT

+39-0652252338; carlotta.manzia@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: June 23, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 23, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after official publication and upon request.
• Access Criteria: Access will be granted upon specific request to the Study Chair, Principal Investigator, Sub-Investigator, or Central Study Contact Person. Researchers must submit a formal proposal outlining the intended use of the data, which will be reviewed for scientific merit and ethical compliance. Approved requests will receive access through a secure data-sharing platform.

Locations

IT (2)