跳至主要内容
临床试验/NCT07322861
NCT07322861尚未招募不适用

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

Umm Al-Qura University0 个研究点目标入组 80 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Frailty Status (Arabic FRAIL Scale)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Virtual Reality-Based Training Program

Experimental

干预措施: Virtual Reality-Based Training Program (Device)

Traditional Physiotherapy Program

Active Comparator

干预措施: Physiotherapy Exercise Program (Other)

结局指标

主要结局

Frailty Status (Arabic FRAIL Scale)

时间窗: Baseline (Week 0) and Post-Intervention (Week 12)

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.

Balance Performance (Berg Balance Scale)

时间窗: Baseline (Week 0) and Post-Intervention (Week 12)

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.

Functional Mobility (Timed Up and Go Test)

时间窗: Time Frame: Baseline (Week 0) and Post-Intervention (Week 12)

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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Hammad Alhasan

Dr

Umm Al-Qura University

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