Physioworks
Peshawar, KPK, 25000, Pakistan
NCT Number: NCT07797699
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Peshawar, KPK, 25000, Pakistan
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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: standard physical therapy
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).
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.
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.
Time frame: 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.
Time frame: 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.
Ibadat International University, Islamabad
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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