Effects of Balance Training with and Without Gaze Stability Exercises on Cognitive Function Balance and Dynamic Postural Stability in Older Adults with Mild Cognitive Impairment

The study aims to evaluate the effects of balance training, with and without gaze stability exercises, on cognitive function, balance, and postural stability in older adults with mild cognitive impairment (MCI). A randomized controlled trial with 30 participants will be conducted at Fauji Foundation Hospital and Chakwal. Participants will be divided into two groups: one receiving balance training with gaze stability exercises, and the other receiving balance training alone. Baseline, 4-week, and 8-week assessments will measure cognitive function (Montreal Cognitive Assessment), balance (Berg Balance Scale), and mobility (Time Up and Go test). Training will consist of 24 sessions over 8 weeks, with sessions lasting 30-50 minutes.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction; Elderly Population
• Intervention / Treatment: Procedure: Balance training group; Procedure: Balance training combined with gaze stability exercises

Detailed Description

OBJECTIVES OF STUDY

1. To determine the effects of balance training with and without gaze stability exercises on cognitive function in older adults with mild cognitive impairment.
2. To determine the effects of balance training with and without gaze stability exercises on balance in older adults with mild cognitive impairment.
3. To determine the effects of balance training with and without gaze stability exercises on mobility in older adults with mild cognitive impairment

HYPOTHESIS

ALTERNATE HYPOTHESIS

1. HA- There is a statistically significant difference in effect of balance training with gaze stability exercises in comparison balance training alone on cognitive function in older adults with MCI. (p<0.05)
2. HA- There is a statistically significant difference in effect of balance training with gaze stability exercises in comparison balance training alone on balance in older adults with MCI. (p<0.05)
3. HA- There is a statistically significant difference in effect of balance training with gaze stability exercises in comparison balance training alone on dynamic postural stability in older adults with MCI. (p<0.05)

NULL HYPOTHESIS

1. H0 - There is no statistically significant difference in effect of balance training with gaze stability exercises in comparison balance training alone on cognitive function in older adults with MCI. (p>0.05)
2. H0 - There is no statistically significant difference in effect of balance training with gaze stability exercises in comparison balance training alone on balance in older adults with MCI. (p>0.05)
3. H0 - There is no statistically significant difference in effect of balance training with gaze stability exercises in comparison balance training alone on dynamic postural stability/mobility in older adults with MCI. (p>0.05)

Research Design: Experimental study. Randomized Control Trial

Clinical setting: Chakwal Study duration: 6 months

Data will be collected on Demographics and general information Cognitive function will be assessed with the help of MOCA (Montreal Cognitive Assessment Scale). Balance will be assessed with the help of BBS (Berg Balance Scale). Dynamic postural stability will be assessed with the help of TUG (Time Up and Go test).

SIGNIFICANCE OF STUDY:

Mild Cognitive Impairment (MCI) is a major risk factor for dementia among older adults, although research into its neurological features is limited. Addressing this gap is crucial given the interrelationship of balance issues and cognitive decline. Combining balance training with gaze stability exercises provides a comprehensive intervention method that shows potential for improving both balance and cognitive function. Studies have highlighted the potential benefits of these therapies for improving overall well-being and functional independence in older persons with MCI. Investigating their combined effects provides valuable insights into optimizing rehabilitation strategies for cognitive function, balance, and dynamic postural stability, thereby contributing to improving quality of life and reducing fall risk in this vulnerable population. This research aims to add data to the existing literature

, exploring tailored interventions that address both physical and cognitive aspects simultaneously. By providing understanding on the effectiveness of such interventions, this study seeks to enhance the care and management of older adults with MCI, ultimately promoting better outcomes and quality of life for this population.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayesha Nishat, DPT; Phone Number: +923369649611; Email: ayeshanishat015@gmail.com

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Recruiting
    • Foundation University College of Physical Thrapy
    • Contact: Muhammad Ehab Azim, MS-NMPT; Phone Number: 637 +92515788171; Email: ehab@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age group: 55 years and above older adults.
• Both male and female.
• Having mild cognitive impairment (MCI) having score of 18-25 on Montreal Cognitive Assessment Scale (Urdu version).
• Ability to understand simple instruction and those who are capable of participating in physical exercise programs.

Exclusion Criteria

• Diagnosed neurological and psychiatric disorders.
• Those unable to engage in physical activity due to mobility limitations.
• Individuals with significant visual and hearing impairments affecting participation in gaze stability exercises.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance Training Group; It includes participants receiving balance training for mild cognitive impairment. Balance training Walking on a flat surface at the beginning of each session for 5-10 minutes Perform different static and dynamic balance exercises along with cognitive tasks. Static standing with feet together with eyes open and closed Semi-tandem stand and tandem stand Forward and backward weight shift exercises Counting backwards by threes, Naming object or animals, Recalling a short sequence of numbers or words. Side stepping, marching, forward and backward walking Hip extension and abduction Cognitive task includes word association or simple math problems. Standing on one leg Relaxation and breathing exercises including deep inhaling and exhaling or walking slowly at the end of each session for 5-10 minutes During training sessions, balance activities and cognitive tasks will be implemented simultaneously.	Procedure: Balance training group; It includes participants receiving balance training for mild cognitive impairment. Balance training Walking on a flat surface at the beginning of each session for 5-10 minutes Perform different static and dynamic balance exercises along with cognitive tasks. Static standing with feet together with eyes open and closed Semi-tandem stand and tandem stand Forward and backward weight shift exercises Counting backwards by threes, Naming object or animals, Recalling a short sequence of numbers or words. Side stepping, marching, forward and backward walking Hip extension and abduction Cognitive task includes word association or simple math problems. Standing on one leg Relaxation and breathing exercises including deep inhaling and exhaling or walking slowly at the end of each session for 5-10 minutes During training sessions, balance activities and cognitive tasks will be implemented simultaneously.
Experimental: Balance Training Combined with Gaze Stability Exercises Group; It includes participants receiving balance training combined with gaze stability exercises for mild cognitive impairment. Balance training Walking on a flat surface at the beginning of each session for 5-10 minutes Perform different static and dynamic balance exercises along with cognitive tasks. Static standing with feet together with eyes open and closed Semi-tandem stand and tandem stand Forward and backward weight shift exercises Counting backwards by threes, Naming object or animals, Recalling a short sequence of numbers or words. Side stepping, marching, forward and backward walking Hip extension and abduction Cognitive task includes word association or simple math problems. Standing on one leg Relaxation and breathing exercises including deep inhaling and exhaling or walking slowly at the end of each session for 5-10 minutes During training sessions, balance activities and cognitive tasks will be implemented simultaneously. Gaze stability exercises Visual tracking exercise	Procedure: Balance training combined with gaze stability exercises; It includes participants receiving balance training combined with gaze stability exercises for mild cognitive impairment. Balance training Walking on a flat surface at the beginning of each session for 5-10 minutes Perform different static and dynamic balance exercises along with cognitive tasks. Static standing with feet together with eyes open and closed Semi-tandem stand and tandem stand Forward and backward weight shift exercises Counting backwards by threes, Naming object or animals, Recalling a short sequence of numbers or words. Side stepping, marching, forward and backward walking Hip extension and abduction Cognitive task includes word association or simple math problems. Standing on one leg Relaxation and breathing exercises including deep inhaling and exhaling or walking slowly at the end of each session for 5-10 minutes During training sessions, balance activities and cognitive tasks will be implemented simultaneously. Gaze stability exercises Visual tracking exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Cognitive function will be assesed by using montreal cognitive assessment scale. It has a total score of 30, with higher numbers indicating better Cognition Function. A normal score is regarded to be 26 or higher. 18-25 = mild cognitive impairment	8 weeks
Balance	Balance will be assessed by using berg balance scale. It is a 14-item objective measure. It is a widely used tool for assessing balance in various populations. The scoring system ranges from 0 to 56, where higher scores indicate better balance. Total scores of 0 to 20 indicate a high risk for falls, 21 to 40 indicate a moderate risk, and 41 to 56 indicate a low risk in adults.	8 weeks
Dynamic Postural Stability	Dynamic Postural Stability will be assessed by using time up and go test. It assesses mobility, balance, walking ability, and fall risk in older adults. It is administered in less than 3 minutes. Scoring of < 10 seconds is considered normal. As the time duration to complete the test increases the risk of fall increases indicating poor dynamic postural stability and mobility.	8 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Cognitive function; Older adults; Balance training; Gaze stability exercises; Dynamic postural stability
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: FUI/CTR/2024/43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No