NCT07797699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 23, 2026

Last Update Submit

August 28, 2026

Conditions

Keywords

Otago Exercise ProgramSensory ReweightingBlindfolded ExerciseGeriatric RehabilitationPostural BalanceFall PreventionQuality of LifeProprioception

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).

Secondary Outcomes (2)

  • Timed Up and Go (TUG) Test

    Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).

  • Quality of Life Assessment Tool SF 36 Model

    Baseline (Week 0), Mid-intervention (Week 3), and Post-intervention (Week 6).

Study Arms (2)

Otago Exercise Program Group (OEP)

ACTIVE COMPARATOR

Participants in this group will undergo a structured, progressive muscle-strengthening and balance-retraining program.

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.

Procedure: Blindfolded Exercise (BFE)

Interventions

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).

Also known as: standard physical therapy
Otago Exercise Program Group (OEP)

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).

Blindfolded Exercise Group (BFE)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physioworks

Peshawar, KPK, 25000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

September 1, 2026

Study Start

May 7, 2026

Primary Completion

July 14, 2026

Study Completion

July 14, 2026

Last Updated

September 1, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations