FrailtyNCT07322861
Virtual Reality-Based vs Traditional Physiotherapy for Balance, Frailty, and Fall Prevention in Adults Aged 45 Years and Older
A study testing Virtual Reality-Based Training Program and Physiotherapy Exercise Program in people with Frailty and Falls, run by Umm Al-Qura University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Frailty, Falls, Balance Deficits
- What is being tested?
- Virtual Reality-Based Training Program and Physiotherapy Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Frailty, Falls, Balance Deficits, Mobility Limitations
- Being tested
- Virtual Reality-Based Training Program, Physiotherapy Exercise Program
- Keywords
- Virtual Reality Rehabilitation, Balance Training, Fall Prevention, Frailty, Exergaming
- Medical subject headings
- Frailty, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Training ProgramDevice
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
Physiotherapy Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Based Training Program | Experimental | Not described Receives: Device: Virtual Reality-Based Training Program |
| Traditional Physiotherapy Program | Active comparator | Not described Receives: Other: Physiotherapy Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Time Frame: Baseline (Week 0) and Post-Intervention (Week 12)
Secondary outcomes (3)
Number of Falls
Falls will be recorded using retrospective 12-month fall history at baseline and a prospective falls diary during the intervention period.
Measured: 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.
Measured: 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.
Measured: Baseline (previous 12 months) and During Intervention (Weeks 1-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hammad Alhasan, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322861
- Sponsor's protocol ID
- HAPO-02-K-012-2025-11-2975
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07322861
- Acronym / sponsor ID
- HAPO-02-K-012-2025-11-2975
- Conditions
- Frailty, Falls, Balance Deficits, Mobility Limitations
- Keywords
- Virtual Reality Rehabilitation, Balance Training, Fall Prevention, Frailty, Exergaming
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Based Training Program | Experimental | Device: Virtual Reality-Based Training Program |
| Traditional Physiotherapy Program | Active comparator | Other: Physiotherapy Exercise Program |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based Training ProgramParticipants 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 | Device | Virtual Reality-Based Training Program |
| Physiotherapy Exercise ProgramParticipants 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. | Other | Traditional Physiotherapy Program |
Primary outcome
Frailty Status (Arabic FRAIL Scale)
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Training Program and Physiotherapy Exercise Program in people with Frailty and Falls, run by Umm Al-Qura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hammad S Alhasan, PhD (966125270000+, hshasan@uqu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Status (Arabic FRAIL Scale) (time frame: Baseline (Week 0) and Post-Intervention (Week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.