Balance Rehabilitation Based on Serious Games

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIRCCS San Raffaele Roma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

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

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Experimental Group (EG)Experimental treatment 1 intervention
Group B: Active comparator (CG)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Cognitive Time Up and Go Test (TUG-C)

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. 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 meanwhile he counting backwards in threes from a random start point. 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 fallTUG

Time frame
Day 0 (T0 - baseline), day 30 (T1 - After treatment).
2

Passive Range of Motion (p-ROM)

Passive ROM refers to the movement of a joint through its range of motion by an external force. It's calculated using goniometer. Goniometer measures with a sensitivity of 1 degree. Elevated degrees of p-rom means high joint mobility.

Time frame
Day 0 (T0 - baseline), day 30 (T1 - After treatment).
3

Ten Meter Walking Test (10MWT)

The 10 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Equipment required consists of a walkway of 10m with additional 2m at both ends, marked with tape, for acceleration \& deceleration (14 m total). The 14-metre walkway is marked 0-, 2-, 12-, and 14-metre points. In addition is required 2 chairs and stopwatch (or timer). The total time taken to ambulate 10 meters is recorded in this way: timing starts when the toes pass the 2-meter mark and stops when the toes pass the 12-meter mark. The total time is recorded in m/s. Low total time in 10MWT means that gait speed is elevate.

Time frame
Day 0 (T0 - baseline), day 30 (T1 - After treatment).
4

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

The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess patient's opinions about their hip and associated problems and to evaluate their symptoms and functional limitations during a therapeutic process. HOOS JR is developed based on the original 40-question questionnaire HOOS. HOOS JR has 6 items and it is shorter than original HOOS. The HOOS is meant to be used over short and long-term intervals to assess changes over time or the effect of treatment. Factors that should be considered when using the HOOS include age, sex, weight, geographic location, other chronic diseases, history of an inactive hip problem, contralateral hip disease, and active knee, ankle, or foot problems. Each question allows for a score ranging from 0 to 4, where 0 corresponds to the absence of symptoms and 4 corresponds to the most severe symptom.

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

Other outcomes

1

Bilateral thigh cytometry.

The measurement of the thigh circumference is performed on both legs. The measurement is taken at the root of the thigh, approximately 1 cm below the gluteal fold.

Time frame
Day 0 (T0 - baseline), day 30 (T1 - After treatment).
2

Number of falls in the last 3 months.

The circumference of the thigh of both legs is measured. The measurement is taken at the root of the thigh, that is, approximately 1 cm below the gluteal fold.

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

Client satisfaction questionnaire .

The Client satisfaction questionnaire investigates the subject's overall satisfaction with participating in the study. It consists of six questions with a score ranging from 0 to 4. A high score corresponds to a high level of satisfaction from the subject.

Time frame
Day 30 (T1 - After treatment).
4

Posturography

Posturography (or stabilometry) is an examination that allows for the assessment and measurement of fine postural control. The examined subject stands on a computerized and sensorized platform, remaining still in an upright position. The recording lasts 30 seconds and is repeated twice with eyes open and arms at the sides, and twice with eyes closed and arms at the sides.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele Roma

Lead sponsor

Ministero della Salute, Italy

Collaborator