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

NCT07322861 | Not Yet Recruiting DMC

• 1 other identifier: HAPO-02-K-012-2025-11-2975
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Frailty; Falls; Balance Deficits; Mobility Limitations

Keywords

Virtual Reality Rehabilitation; Balance Training; Fall Prevention; Frailty; Exergaming

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Number of Falls

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

• Grip Strength

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

• Quality of Life (SF-12)

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

Other Outcomes (11)

• Age

  Baseline (Week 0)

• Weight

  Baseline (Week 0)

• Height

  Baseline (Week 0)

Study Arms (2)

Virtual Reality-Based Training Program

EXPERIMENTAL

Device: Virtual Reality-Based Training Program

Traditional Physiotherapy Program

ACTIVE COMPARATOR

Other: Physiotherapy Exercise Program

Interventions

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

Virtual Reality-Based Training Program

Physiotherapy Exercise Program OTHER

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.

Traditional Physiotherapy Program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umm Al-Qura University: lead

MeSH Terms

Conditions

Frailty; Mobility Limitation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Hammad S Alhasan, PhD

CONTACT

966125270000+; hshasan@uqu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Participants and treating physiotherapists are not blinded due to the nature of the interventions. Data analysts will receive de-identified datasets labeled by group codes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This is a 12-week, two-arm, parallel-group interventional study comparing VR-based PABLO training with traditional Otago-based physiotherapy. Participants attend supervised sessions twice weekly (30 minutes each), with outcomes assessed at baseline (week 0) and post-intervention (week 12).

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share