Accidental FallNCT07797699
Effects of Otago Exercise Program Vs Blind Folded Exercise on Falls, Balance and Quality of Life in Geriatric Population.
A study testing Otago Exercise Program (OEP) and Blindfolded Exercise (BFE) in people with Accidental Fall and Postural Instability, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
As people age, maintaining balance can become more difficult, which increases the risk of dangerous falls. This clinical study aims to compare two different physical therapy programs to see which one is more effective at improving balance, reducing the frequency of falls, and enhancing the overall quality of life for… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Fall, Postural Instability, Balance Assessment
- What is being tested?
- Otago Exercise Program (OEP) and Blindfolded Exercise (BFE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 7 May 2026to 14 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of fall within last 3 months.
- Berg balance should be less than or equal to 40.
- Patient age 60 and above.
- Romberg test positive.
Who cannot join
- Participants having cognition problems or a language barrier.
- Physical disability (fracture or amputation).
- Patient those have Secondary neurological condition (Parkinson's disease, stroke).
- Previous surgery for last 6 weeks. Unstable Cardiovascular and pulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
As people age, maintaining balance can become more difficult, which increases the risk of dangerous falls. This clinical study aims to compare two different physical therapy programs to see which one is more effective at improving balance, reducing the frequency of falls, and enhancing the overall quality of life for older adults (aged 60 and older).
The first program is the Otago Exercise Program (OEP), which is a well-established, widely used routine focused on leg strengthening and active balance exercises. The second program is Blindfolded Exercise (BFE), which uses a safety harness or support bars while participants perform balance movements with their eyes covered. Temporarily removing vision forces the brain and body to rely more heavily on inner-ear balance systems (vestibular) and muscle/joint awareness (proprioception) to stay upright.
A total of 40 participants will be randomly assigned to one of these two exercise groups. Both groups will attend 30- to 45-minute physical therapy sessions, 3 times a week, for a total of 6 weeks. Researchers will assess participants' balance, walking speed, and overall quality of life at the beginning, middle, and end of the study to determine if sensory-deprived training (blindfolded) or muscle-strengthening training (Otago) offers better protection against falls.
Read the detailed description
This study is a single-blinded, parallel-group, Randomized Controlled Trial (RCT) designed to compare the clinical efficacy of a strength-and-balance-based motor retraining program against a sensory-reweighting paradigm in community-dwelling older adults. The primary objective is to evaluate and contrast the effects of these distinct therapeutic approaches on postural stability, fall frequency, and health-related quality of life.
Participant Recruitment \& Randomization:
Forty (40) participants aged 60 and older who meet the inclusion criteria will be recruited for this study. Eligible participants must have a history of a fall within the last three months, a Berg Balance Scale (BBS) score of 40 or lower, a positive Romberg test, and the ability to perform the Timed Up and Go (TUG) test. Following baseline assessments, participants will be randomly allocated to either Group 1 (Otago Exercise Program) or Group 2 (Blindfolded Exercise) in a 1:1 ratio using the sealed envelope randomization method.
Intervention Protocols:
All participants will undergo a 6-week intervention period consisting of 3 sessions per week, with each session lasting 30 to 45 minutes. Both groups will receive a standardized baseline physical therapy session (including a brief warm-up, heating pads, and light aerobic conditioning) prior to their specialized training:
- Group 1: Otago Exercise Program (OEP): This progressive program focuses on lower limb muscle strengthening (targeting the quadriceps, hamstrings, gluteus medius, calves, and tibialis anterior) and progressive balance retraining (e.g., heel-to-toe walking, backward walking, and sit-to-stand transitions). Muscle-strengthening exercises will be progressively loaded using ankle weights (ranging from 500g up to 1kg) depending on individual tolerance, while balance activities will advance from supported to unsupported conditions.
- Group 2: Blindfolded Exercise (BFE): This sensory-reweighting program utilizes temporary visual deprivation via a blindfold to limit visual input during functional balance exercises. Exercises are conducted under strict safety conditions (utilizing support bars, harnesses, and knee stabilizers as needed to prevent falls). The difficulty of the tasks will progress sequentially over the 6 weeks (e.g., transitioning from a supported wide-base stance to an unsupported tandem stance, and eventually to an unsupported single-leg stance, with eyes closed).
Outcome Measures \& Assessment:
Clinical outcomes will be measured at three distinct time points: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6). The primary outcomes include:
- Postural Balance: Assessed using the Berg Balance Scale (BBS).
- Functional Mobility \& Fall Risk: Evaluated using the Timed Up and Go (TUG) test.
- Health-Related Quality of Life: Measured using the SF-36 health survey.
Statistical Analysis:
Data will be analyzed using SPSS software. Normality of the data will be assessed using the Shapiro-Wilk test. Within-group changes from baseline to post-intervention will be evaluated using paired-sample t-tests (or Wilcoxon signed-rank tests for non-parametric data). Between-group differences will be analyzed using independent-sample t-tests (or Mann-Whitney U tests). A Mixed-Model Analysis of Variance (ANOVA) will be utilized to determine the interaction effects between the groups over the three measurement intervals, with statistical significance set at p < 0.05.
- Conditions
- Accidental Fall, Postural Instability, Balance Assessment
- Being tested
- Otago Exercise Program (OEP), Blindfolded Exercise (BFE)
- Keywords
- Otago Exercise Program, Sensory Reweighting, Blindfolded Exercise, Geriatric Rehabilitation, Postural Balance, Fall Prevention, Quality of Life, Proprioception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise Program (OEP)Procedure or surgery
Also called standard physical therapy
A 6-week progressive exercise program performed 3 times per week (30-45 minutes per session). It includes specific lower-limb muscle-strengthening exercises using progressive ankle weights (500g to 1kg) and progressive static/dynamic balance training (e.g., tandem walking, backward walking, sit-to-stand transitions).
Blindfolded Exercise (BFE)Procedure or surgery
A 6-week sensory-reweighting balance program performed 3 times per week (30-45 minutes per session) with participants wearing a blindfold to eliminate visual cues. Exercises progress from wide-base supported stances to narrow-base and single-leg unsupported stances, conducted using strict safety measures (e.g., parallel bars, safety harnesses, and knee stabilizers).
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Program Group (OEP) | Active comparator | Participants in this group will undergo a structured, progressive muscle-strengthening and balance-retraining program. Receives: Procedure: Otago Exercise Program (OEP) |
| Blindfolded Exercise Group (BFE) | Experimental | Participants in this group will undergo a progressive balance training program under temporary visual deprivation using a blindfold. Receives: Procedure: Blindfolded Exercise (BFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
A 14-item objective measure designed to assess static balance and fall risk in adult populations. Each item is scored on a 5-point scale ranging from 0 (lowest function) to 4 (highest function), with a maximum total score of 56 points. Lower scores indicate poorer balance and higher fall risk.
Measured: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
Berg Balance Scale(BBS)
A 14-item objective measure designed to assess static balance and fall risk in adult populations. Each item is scored on a 5-point scale ranging from 0 (lowest function) to 4 (highest function), with a maximum total score of 56 points. Lower scores indicate poorer balance and higher fall risk.
Measured: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
Secondary outcomes (2)
Timed Up and Go (TUG) Test
A mobility and dynamic balance assessment that measures the time (in seconds) taken by a participant to rise from a standard armchair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better functional mobility and lower fall risk.
Measured: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
Quality of Life Assessment Tool SF 36 Model
A 36-item self-reported questionnaire used to evaluate health-related quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores for each domain range from 0 to 100, where higher scores indicate better health state and higher quality of life.
Measured: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start7 May 2026
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a single-blinded, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Eligible participants will be randomly assigned to one of two distinct treatment arms: the Otago Exercise Program (OEP) group or the Blindfolded Exercise (BFE) group. Participants in both arms will undergo their respective 6-week progressive physical therapy interventions concurrently. Assessments for both groups will be performed at identical time intervals: baseline (Week 0), mid-intervention (Week 3), and post-intervention (Week 6) to compare the treatment effects between the two parallel cohorts.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797699
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/05/257
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 1 Sep 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 to maintain participant confidentiality and privacy in accordance with institutional review board (IRB) and ethical guidelines. Aggregate study results and outcomes will be made available through peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Otago Exercise Program Vs Blind Folded Exercise on Falls, Balance and Quality of Life in Geriatric Population.
- ClinicalTrials.gov ID
- NCT07797699
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/05/257
- Conditions
- Accidental Fall, Postural Instability, Balance Assessment
- Keywords
- Otago Exercise Program, Sensory Reweighting, Blindfolded Exercise, Geriatric Rehabilitation, Postural Balance, Fall Prevention, Quality of Life, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 1 Sep 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.
As people age, maintaining balance can become more difficult, which increases the risk of dangerous falls. This clinical study aims to compare two different physical therapy programs to see which one is more effective at improving balance, reducing the frequency of falls, and enhancing the overall quality of life for older adults (aged 60 and older).
The first program is the Otago Exercise Program (OEP), which is a well-established, widely used routine focused on leg strengthening and active balance exercises. The second program is Blindfolded Exercise (BFE), which uses a safety harness or support bars while participants perform balance movements with their eyes covered. Temporarily removing vision forces the brain and body to rely more heavily on inner-ear balance systems (vestibular) and muscle/joint awareness (proprioception) to stay upright.
A total of 40 participants will be randomly assigned to one of these two exercise groups. Both groups will attend 30- to 45-minute physical therapy sessions, 3 times a week, for a total of 6 weeks. Researchers will assess participants' balance, walking speed, and overall quality of life at the beginning, middle, and end of the study to determine if sensory-deprived training (blindfolded) or muscle-strengthening training (Otago) offers better protection against falls.
Detailed description
This study is a single-blinded, parallel-group, Randomized Controlled Trial (RCT) designed to compare the clinical efficacy of a strength-and-balance-based motor retraining program against a sensory-reweighting paradigm in community-dwelling older adults. The primary objective is to evaluate and contrast the effects of these distinct therapeutic approaches on postural stability, fall frequency, and health-related quality of life.
Participant Recruitment \& Randomization:
Forty (40) participants aged 60 and older who meet the inclusion criteria will be recruited for this study. Eligible participants must have a history of a fall within the last three months, a Berg Balance Scale (BBS) score of 40 or lower, a positive Romberg test, and the ability to perform the Timed Up and Go (TUG) test. Following baseline assessments, participants will be randomly allocated to either Group 1 (Otago Exercise Program) or Group 2 (Blindfolded Exercise) in a 1:1 ratio using the sealed envelope randomization method.
Intervention Protocols:
All participants will undergo a 6-week intervention period consisting of 3 sessions per week, with each session lasting 30 to 45 minutes. Both groups will receive a standardized baseline physical therapy session (including a brief warm-up, heating pads, and light aerobic conditioning) prior to their specialized training:
- Group 1: Otago Exercise Program (OEP): This progressive program focuses on lower limb muscle strengthening (targeting the quadriceps, hamstrings, gluteus medius, calves, and tibialis anterior) and progressive balance retraining (e.g., heel-to-toe walking, backward walking, and sit-to-stand transitions). Muscle-strengthening exercises will be progressively loaded using ankle weights (ranging from 500g up to 1kg) depending on individual tolerance, while balance activities will advance from supported to unsupported conditions.
- Group 2: Blindfolded Exercise (BFE): This sensory-reweighting program utilizes temporary visual deprivation via a blindfold to limit visual input during functional balance exercises. Exercises are conducted under strict safety conditions (utilizing support bars, harnesses, and knee stabilizers as needed to prevent falls). The difficulty of the tasks will progress sequentially over the 6 weeks (e.g., transitioning from a supported wide-base stance to an unsupported tandem stance, and eventually to an unsupported single-leg stance, with eyes closed).
Outcome Measures \& Assessment:
Clinical outcomes will be measured at three distinct time points: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6). The primary outcomes include:
- Postural Balance: Assessed using the Berg Balance Scale (BBS).
- Functional Mobility \& Fall Risk: Evaluated using the Timed Up and Go (TUG) test.
- Health-Related Quality of Life: Measured using the SF-36 health survey.
Statistical Analysis:
Data will be analyzed using SPSS software. Normality of the data will be assessed using the Shapiro-Wilk test. Within-group changes from baseline to post-intervention will be evaluated using paired-sample t-tests (or Wilcoxon signed-rank tests for non-parametric data). Between-group differences will be analyzed using independent-sample t-tests (or Mann-Whitney U tests). A Mixed-Model Analysis of Variance (ANOVA) will be utilized to determine the interaction effects between the groups over the three measurement intervals, with statistical significance set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a single-blinded, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Eligible participants will be randomly assigned to one of two distinct treatment arms: the Otago Exercise Program (OEP) group or the Blindfolded Exercise (BFE) group. Participants in both arms will undergo their respective 6-week progressive physical therapy interventions concurrently. Assessments for both groups will be performed at identical time intervals: baseline (Week 0), mid-intervention (Week 3), and post-intervention (Week 6) to compare the treatment effects between the two parallel cohorts.
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program Group (OEP) | Active comparator | Procedure: Otago Exercise Program (OEP)Participants in this group will undergo a structured, progressive muscle-strengthening and balance-retraining program. |
| Blindfolded Exercise Group (BFE) | Experimental | Procedure: Blindfolded Exercise (BFE)Participants in this group will undergo a progressive balance training program under temporary visual deprivation using a blindfold. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of fall within last 3 months.
- Berg balance should be less than or equal to 40.
- Patient age 60 and above.
- Romberg test positive.
Key exclusion criteria (4 listed)
- Participants having cognition problems or a language barrier.
- Physical disability (fracture or amputation).
- Patient those have Secondary neurological condition (Parkinson's disease, stroke).
- Previous surgery for last 6 weeks. Unstable Cardiovascular and pulmonary disease.
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 |
|---|---|---|
| Otago Exercise Program (OEP)Also: standard physical therapyA 6-week progressive exercise program performed 3 times per week (30-45 minutes per session). It includes specific lower-limb muscle-strengthening exercises using progressive ankle weights (500g to 1kg) and progressive static/dynamic balance training (e.g., tandem walking, backward walking, sit-to-stand transitions). | Procedure or surgery | Otago Exercise Program Group (OEP) |
| Blindfolded Exercise (BFE)A 6-week sensory-reweighting balance program performed 3 times per week (30-45 minutes per session) with participants wearing a blindfold to eliminate visual cues. Exercises progress from wide-base supported stances to narrow-base and single-leg unsupported stances, conducted using strict safety measures (e.g., parallel bars, safety harnesses, and knee stabilizers). | Procedure or surgery | Blindfolded Exercise Group (BFE) |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
A 14-item objective measure designed to assess static balance and fall risk in adult populations. Each item is scored on a 5-point scale ranging from 0 (lowest function) to 4 (highest function), with a maximum total score of 56 points. Lower scores indicate poorer balance and higher fall risk.
Berg Balance Scale(BBS)
Time frame: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
A 14-item objective measure designed to assess static balance and fall risk in adult populations. Each item is scored on a 5-point scale ranging from 0 (lowest function) to 4 (highest function), with a maximum total score of 56 points. Lower scores indicate poorer balance and higher fall risk.
2 secondary outcomes
Timed Up and Go (TUG) Test
Time frame: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
Quality of Life Assessment Tool SF 36 Model
Time frame: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly to maintain participant confidentiality and privacy in accordance with institutional review board (IRB) and ethical guidelines. Aggregate study results and outcomes will be made available through peer-reviewed publications.
Related trials for Accidental Fall
Not yet recruiting
Effects of a Novel Perturbation Balance Training Program on Laboratory and Real-World Trip-Induced Losses of Balance and Falls Among Balance-Impaired Older Adults
Accidental Fall
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Enrolling by invitation
Preventing Loss of Independence Through Exercise in Community Living Centers
Dementia, Cognitive Dysfunction
Not yet recruitingObservational study
Turkish Adaptation of the Multidimensional Falls Efficacy Scale in Older Adults
Balance Control in Elderly, Falls (Accidents) in Old Age
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program (OEP) and Blindfolded Exercise (BFE) in people with Accidental Fall and Postural Instability, run by Ibadat International University, Islamabad at 1 site in Pakistan.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).). The study lists 2 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 1 Sep 2026.