Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:25 AM
Study NCT ID:
NCT07322861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-Based vs Traditional Physiotherapy for Balance, Frailty, and Fall Prevention in Adults Aged 45 Years and Older
Sponsor:
Umm Al-Qura University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: