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

A Controlled Trial Comparing Virtual Reality-Based PABLO Training With Traditional Otago Physiotherapy for Balance, Frailty, and Fall Risk in Adults Aged 45 Years and Older

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Falls; Mobility Limitations; Balance Deficits
• Intervention / Treatment: Device: Virtual Reality-Based Training Program; Other: Physiotherapy Exercise Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hammad S Alhasan, PhD; Phone Number: 966125270000+; Email: hshasan@uqu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Ability and willingness to provide written informed consent

Exclusion Criteria:

• 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
• Any medical condition deemed unsafe for participation by the treating physiotherapist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality-Based Training Program	Device: Virtual Reality-Based Training 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
Active Comparator: Traditional Physiotherapy Program	Other: Physiotherapy Exercise Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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: Baseline (Week 0) and Post-Intervention (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Falls	Falls will be recorded using retrospective 12-month fall history at baseline and a prospective falls diary during the intervention period.	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.	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.	Baseline (previous 12 months) and During Intervention (Weeks 1-12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Baseline (Week 0)
Weight	Weight in kilograms	Baseline (Week 0)
Height	height in centimetre	Baseline (Week 0)
Body mass index	weight and height will be combined to report BMI in kg/m^2	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.	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.	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.	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.	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.	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.	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.	Throughout Intervention (Weeks 1-12)

Collaborators and Investigators

• Sponsor: Umm Al-Qura University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Frailty; Exergaming; Fall Prevention; Balance Training; Virtual Reality Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Mobility Limitation
• Other Study ID Numbers: HAPO-02-K-012-2025-11-2975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No