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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Virtual Reality-Based Training Program
DeviceParticipants 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
Number of Falls
Falls will be recorded using retrospective 12-month fall history at baseline and a prospective falls diary during the intervention period.
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.
Quality of Life (SF-12)
Health-related quality of life assessed using the SF-12 questionnaire, covering physical and mental health domains.
Other outcomes
Age
Age in years
Weight
Weight in kilograms
Height
height in centimetre
Body mass index
weight and height will be combined to report BMI in kg/m\^2
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: