Accidental Fall, Balance Assessment, Postural Instability
Conditions
Keywords
Otago Exercise Program, Sensory Reweighting, Blindfolded Exercise, Geriatric Rehabilitation, Postural Balance, Fall Prevention, Quality of Life, Proprioception
Brief 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 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.
Interventions
PROCEDUREOtago Exercise Program (OEP)
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).
PROCEDUREBlindfolded 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).
Sponsors
Ibadat International University, Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Due to the physical nature of the physical therapy interventions, participants and the therapists administering the programs cannot be realistically masked to their group allocations. Therefore, a single-blind model is utilized where masking is strictly applied to the Outcomes Assessor. The independent assessor responsible for conducting the baseline, mid-intervention, and post-intervention measurements (using the Berg Balance Scale and Timed Up and Go test) will remain completely blinded to the participants' group assignments throughout the 6-week study period.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) Test | Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6). | 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. |
| Quality of Life Assessment Tool SF 36 Model | Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6). | 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. |
Countries
Pakistan
Outcome results
None listed