Virtual Reality-Based vs Traditional Physiotherapy for Balance, Frailty, and Fall Prevention in Adults Aged 45 Years and Older

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUmm Al-Qura University

About this trial

This study will compare two exercise-based rehabilitation programs to improve balance and reduce fall risk in adults aged 45 years and older who have had at least one fall in the past year or have balance problems. Participants will be assigned to one of two groups: (1) a virtual reality (VR) exercise program using the PABLO system, or (2) a traditional physiotherapy program based on the Otago approach. Both programs will include balance training, strength/power exercises, aerobic activity, and flexibility. The program will last 12 weeks, with two supervised sessions per week (about 30 minutes each). Assessments will be completed at the start of the study and again after 12 weeks. The main outcomes include frailty status, number of falls, mobility (Timed Up and Go test), and balance (Berg Balance Scale). Additional outcomes include grip strength, quality of life (SF-12), and program adherence and safety. The study will help determine whether VR-based rehabilitation improves participation and outcomes compared with traditional physiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 40 years and older

History of at least one fall in the past 12 months OR clinical evidence of balance dysfunction

Ability to walk at least 10 meters, with or without an assistive device

Adequate cognitive function, defined as Mini-Mental State Examination (MMSE) score ≥ 24

Disqualifiers

Severe cognitive impairment (MMSE < 24)

Unstable cardiovascular, musculoskeletal, or neurological conditions that contraindicate exercise participation

Severe uncorrected visual or auditory impairment that interferes with training or assessments

Current participation in another structured exercise or rehabilitation program

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality-Based Training Program

    Device

    Participants assigned to this arm will receive a virtual reality (VR)-based exercise program using the PABLO system. The intervention will be delivered over 12 weeks, with two supervised sessions per week (approximately 30 minutes per session). Training will include interactive balance exercises with real-time biofeedback, strength and power tasks, aerobic stepping activities, and flexibility exercises. Exercise intensity and progression will be guided by perceived exertion and task performance. The program is designed to improve balance control, mobility, strength, and engagement while reducing fall risk

  • Physiotherapy Exercise Program

    Other intervention

    Participants assigned to this arm will receive a traditional physiotherapy program based on the Otago Exercise Programme. The intervention will be delivered over 12 weeks, with two supervised sessions per week (approximately 30 minutes per session). The program will include balance training, lower-limb strength and power exercises, aerobic components, and flexibility exercises, following established Otago progression principles. This program aims to improve balance, mobility, and physical function and reduce fall risk using conventional physiotherapy methods.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Virtual Reality-Based Training ProgramExperimental treatment 1 intervention
Group B: Traditional Physiotherapy ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frailty Status (Arabic FRAIL Scale)

Frailty will be assessed using the validated Arabic FRAIL scale, which includes five domains: fatigue, resistance, ambulation, illnesses, and weight loss. Scores range from 0 (robust) to 5 (frail), with higher scores indicating greater frailty.

Time frame
Baseline (Week 0) and Post-Intervention (Week 12)
2

Balance Performance (Berg Balance Scale)

Balance will be measured using the Berg Balance Scale (BBS), a 14-item clinical test of static and dynamic balance. Total scores range from 0 to 56, with lower scores indicating poorer balance and higher fall risk.

Time frame
Baseline (Week 0) and Post-Intervention (Week 12)
3

Functional Mobility (Timed Up and Go Test)

Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down. Longer times indicate greater mobility impairment and increased fall risk.

Time frame
Time Frame: Baseline (Week 0) and Post-Intervention (Week 12)

Secondary outcomes

1

Number of Falls

Falls will be recorded using retrospective 12-month fall history at baseline and a prospective falls diary during the intervention period.

Time frame
Baseline (previous 12 months) and During Intervention (Weeks 1-12)
2

Grip Strength

Handgrip strength measured using a Jamar dynamometer or PABLO hand sensors. Three trials will be performed on the dominant hand, with the best value (kg) recorded.

Time frame
Baseline (previous 12 months) and During Intervention (Weeks 1-12)
3

Quality of Life (SF-12)

Health-related quality of life assessed using the SF-12 questionnaire, covering physical and mental health domains.

Time frame
Baseline (previous 12 months) and During Intervention (Weeks 1-12)

Other outcomes

1

Age

Age in years

Time frame
Baseline (Week 0)
2

Weight

Weight in kilograms

Time frame
Baseline (Week 0)
3

Height

height in centimetre

Time frame
Baseline (Week 0)
4

Body mass index

weight and height will be combined to report BMI in kg/m\^2

Time frame
Baseline (Week 0)

Locations

This trial has no locations.

Sponsors and contacts

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