An interventional study of Virtual Reality-Based Training Program and Physiotherapy Exercise Program in Frailty, Falls and Balance Deficits, sponsored by Umm Al-Qura University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Prevention
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.
Falls and frailty are major contributors to functional decline, loss of independence, and reduced quality of life in middle-aged and older adults. Balance impairment, muscle weakness, and fear of falling often coexist and interact, creating a cycle of reduced physical activity, deconditioning, and increased fall risk. Exercise-based physiotherapy programs, such as the Otago program, are effective for fall prevention; however, long-term adherence remains a major challenge, particularly in unsupervised or home-based settings. Poor adherence can substantially limit the clinical benefits of rehabilitation.
Virtual reality (VR)-based rehabilitation has emerged as a promising approach to address these challenges by improving engagement, motivation, and task-specific motor learning through real-time feedback and interactive exercises. Sensor-based VR systems, such as the PABLO system, allow targeted training of balance, strength, and functional movements while providing objective performance feedback. Although VR interventions have shown beneficial effects on balance and mobility in older adults, direct comparisons with conventional physiotherapy programs in adults at risk of falls remain limited.
This study is designed to compare the effects of a VR-based PABLO training program with a traditional Otago-based physiotherapy program in adults aged 45 years and older who have a history of falls or balance dysfunction. Participants will undergo a 12-week intervention consisting of twice-weekly, supervised exercise sessions. Both programs are structured to include balance training, strength and power exercises, aerobic components, and flexibility, with balance and strength emphasized as core elements.
The study will evaluate changes in frailty status, fall frequency, balance, mobility, grip strength, and quality of life from baseline to post-intervention. In addition, adherence, compliance, and safety outcomes will be monitored to assess feasibility and tolerability of both approaches. By comparing a technology-enhanced rehabilitation program with a well-established traditional physiotherapy model, this trial aims to generate evidence to inform clinical decision-making and support the integration of VR-based interventions into fall prevention and frailty management strategies for adults at increased risk of functional decline.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Umm Al-Qura University is the lead sponsor of 47 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Virtual Reality-Based Training Program
Other: Physiotherapy Exercise Program
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
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.
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)
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)
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)
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)
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)
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)
Age
Age in years
Time frame: Baseline (Week 0)
Weight
Weight in kilograms
Time frame: Baseline (Week 0)
Height
height in centimetre
Time frame: Baseline (Week 0)
Body mass index
weight and height will be combined to report BMI in kg/m\^2
Time frame: Baseline (Week 0)
Number of Morbidities
The number of chronic medical conditions will be recorded for each participant based on self-report at baseline. Conditions will be summed to generate a total morbidity count, with higher values indicating greater multimorbidity burden.
Time frame: Baseline (Week 0)
Presence of Musculoskeletal Pain
The presence of musculoskeletal pain will be recorded based on participant self-report. Pain will be classified as present or absent at the time of assessment.
Time frame: Baseline (Week 0)
Smoking Status
Smoking status will be recorded based on participant self-report and classified as current smoker or non-smoker at baseline.
Time frame: Baseline (Week 0)
Specific chronic diseases
The presence of specific chronic diseases will be recorded at baseline based on participant self-report. Conditions assessed will include physician-diagnosed hypertension, diabetes mellitus, cardiovascular disease, and other chronic conditions. Each condition will be recorded as present or absent.
Time frame: Baseline (Week 0)
Polypharmacy Status
Polypharmacy will be assessed at baseline based on participant self-report of regular medication use. Polypharmacy will be defined as the concurrent use of five or more medications and recorded as present or absent.
Time frame: Baseline (Week 0)
Intervention Adherence
Adherence assessed as the percentage of attended sessions out of the planned 24 sessions and completion of prescribed exercises or VR tasks.
Time frame: Throughout Intervention (Weeks 1-12)
Safety and Adverse Events
* Falls occurring during supervised intervention sessions will be recorded using a standardized adverse event log. * Episodes of dizziness reported or observed during intervention sessions will be recorded as adverse events. * New or worsened musculoskeletal pain occurring during or immediately after intervention sessions will be recorded as adverse events. * Cardiovascular symptoms, including chest discomfort, palpitations, shortness of breath, or abnormal cardiovascular responses during training sessions, will be recorded as adverse events.
Time frame: Throughout Intervention (Weeks 1-12)
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to ethical and confidentiality considerations. The informed consent obtained from participants does not include permission for public sharing of de-identified individual-level data. Aggregate study results will be reported through publications and presentations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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