- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07608991
Effects of Combined Cervical and Oculomotor Exercises on Dynamic Balance in Elderly
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosed vestibular disorders
- Neurological or musculoskeletal conditions affecting balance.
- Patients with VBI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: occulomotor exercises with otago exercises group B
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 |
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:
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Experimental: Group A (Cervical + Oculomotor + Otago)
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 |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Balance
Time Frame: 6 weeks
|
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
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6 weeks
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Functional Mobility
Time Frame: 6 weeks
|
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
Interpretation: Lower time indicates better performance |
6 weeks
|
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Dynamic Balance
Time Frame: 6 weeks
|
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
|
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Dizziness related disability
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/FUCP/CTR/Neuro/AmnaMalik
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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