NCT07608991

Brief Summary

This study focuses on improving balance in elderly individuals (aged 60-80 years) who may experience dizziness or instability while walking or performing daily activities. Poor balance increases the risk of falls, which can lead to serious injuries and loss of independence. The study compares two types of exercise programs: One group performs combined cervical (neck) exercises + eye (oculomotor) exercises + Otago balance exercises The other group performs eye (oculomotor) exercises + Otago balance exercises only These exercises are done 3 times per week for 6 weeks, with each session lasting 30-45 minutes. The goal is to determine whether combining neck and eye exercises improves balance more effectively than eye exercises alone. This research may help: Reduce fall risk in elderly people Improve mobility and independence Provide better rehabilitation programs for physiotherapists

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

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

November 18, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 18, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

Dynamic BalanceElderlyCervical ExercisesOculomotor ExercisesOtago Exercise ProgramFall PreventionDizzinessPostural ControlRehabilitation

Outcome Measures

Primary Outcomes (4)

  • Dynamic Balance

    Berg Balance Scale (BBS) was used Cut-off Values Greater than 45 → Increased risk of falls 21-40 → Moderate balance impairment Outcome Interpretation Higher score = Better balance

    6 weeks

  • Functional Mobility

    The Timed Up and Go Test (TUG) was used Cut-off Values: less than 10 seconds → Normal mobility 10-19 seconds → Good mobility 20-29 seconds → Mild impairment * 30 seconds → Severe impairment \> 13.5 seconds → Increased risk of falls (important clinical cutoff) Interpretation: Lower time indicates better performance

    6 weeks

  • Dynamic Balance

    Four Square Step Test was used to evaluate dynamic balance Cut-off Values: \< 15 seconds → Normal performance \> 15 seconds → Increased risk of falls Interpretation: Lower time indicates better balance

    6 weeks

  • Dizziness related disability

    4\. Dizziness Handicap was used Cut-off Values: 0-30 → Mild handicap (used in inclusion criteria) 31-60 → Moderate handicap 61-100 → Severe handicap Interpretation: Higher score indicates greater dizziness-related disability

    6 weeks

Study Arms (2)

occulomotor exercises with otago exercises group B

ACTIVE COMPARATOR

Frequency: 3 sessions/week \| Duration: 30-45 min \* Week 1-2: Eye exercises 10-12 reps, VOR x1 (30-40 sec), basic balance training, walking 5-12 min \* Week 3-4: Eye exercises 12-15 reps, VOR x1→x2 (1 min), moderate balance training, walking 12-15 min \* Week 5-6: Eye exercises 15-20 reps, VOR x1+x2 (1-2 min), advanced balance training, walking 15-20 min

Procedure: occulomotor with otago exercises

Group A (Cervical + Oculomotor + Otago)

EXPERIMENTAL

* Frequency: 3 sessions/week \| Duration: 30-45 min * Week 1-2: Cervical ROM 10-12 reps, chin tuck 5-7 sec ×10, isometrics 5-6 sec ×5-6, eye exercises 10-12 reps, VOR x1 (30-40 sec), walking 5-12 min \* Week 3-4: Cervical ROM 12-15 reps, chin tuck 8-10 sec ×12, isometrics 7-8 sec ×8-10, eye exercises 12-15 reps, VOR x1→x2 (1 min), walking 12-15 min \* Week 5-6: Cervical ROM 15-20 reps, chin tuck 10-12 sec ×15, isometrics 10 sec ×10-12, eye exercises 15-20 reps, VOR x1+x2 (1-2 min), walking 15-20 min

Procedure: Combined Cervical and Oculomotor Exercises with Otago Exercises

Interventions

Smooth pursuit exercises, where the eyes follow a moving target horizontally, vertically, and diagonally while keeping the head still. Saccadic eye movements, involving quick shifts of gaze between two stationary targets. Gaze stability (VOR x1 and VOR x2) exercises, involving head movements while maintaining focus on a target, and moving the head and target in opposite directions. All participants will perform the Otago exercise program, a well-established, evidence-based fall prevention program focusing on lower limb strengthening and dynamic balance. It includes: * Strengthening exercises (e.g., knee extensions, hip abduction, calf raises). * Static and dynamic balance exercises (e.g., tandem stance, backward walking, sit-to-stand without using hands). * A progressive walking plan to improve endurance and confidence during ambulation.

occulomotor exercises with otago exercises group B

Cervical range of motion exercises in flexion, extension, rotation, and side bending (gentle, controlled movements). Chin tuck exercises in supine or sitting positions to activate deep cervical flexors. Isometric neck strengthening exercises (flexion, extension, lateral flexion), focusing on controlled, static holds. Occulomotor Exercises: Smooth pursuit exercises, where the eyes follow a moving target horizontally, vertically, and diagonally while keeping the head still. Saccadic eye movements, involving quick shifts of gaze between two stationary targets. Gaze stability (VOR x1 and VOR x2) exercises, involving head movements while maintaining focus on a target, and moving the head in opposite direction Otago exercises Strengthening exercises (e.g., knee extensions, hip abduction, calf raises). Static and dynamic balance exercises (e.g., tandem stance, backward walking, sit-to-stand without using hands). A progressive walking plan to improve endurance and confidence during ambulation.

Group A (Cervical + Oculomotor + Otago)

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female participants aged 60-80 years.
  • DHI-mild score(0-30)
  • Ability to follow instructions and participate in exercises.
  • BBS moderate (21-40)
  • Normal to corrected vision
  • Negative Dix Hallpike

You may not qualify if:

  • Diagnosed vestibular disorders
  • Neurological or musculoskeletal conditions affecting balance.
  • Patients with VBI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 27, 2026

Study Start

November 18, 2025

Primary Completion

May 10, 2026

Study Completion

May 10, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations