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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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 functi

Primary outcome measures

• Frailty Status (Arabic FRAIL Scale) [Time frame: Baseline (Week 0) and Post-Intervention (Week 12)]
• Balance Performance (Berg Balance Scale) [Time frame: Baseline (Week 0) and Post-Intervention (Week 12)]
• Functional Mobility (Timed Up and Go Test) [Time frame: Time Frame: Baseline (Week 0) and Post-Intervention (Week 12)]

Secondary outcome measures (3)

• Number of Falls [Time frame: Baseline (previous 12 months) and During Intervention (Weeks 1-12)]
• Grip Strength [Time frame: Baseline (previous 12 months) and During Intervention (Weeks 1-12)]
• Quality of Life (SF-12) [Time frame: Baseline (previous 12 months) and During Intervention (Weeks 1-12)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07322861 · HAPO-02-K-012-2025-11-2975

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗