Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06672367
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Foundation University Islamabad
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: