Elderly PopulationNCT06672367
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
A study testing Balance training group and Balance training combined with gaze stability exercises in people with Elderly Population and Cognitive Dysfunction, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Elderly Population, Cognitive Dysfunction
- What is being tested?
- Balance training group and Balance training combined with gaze stability exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Thrapy
Islamabad, 44000
Muhammad Ehab Azim, MS-NMPT, +92515788171 ext. 637, ehab@fui.edu.pk
About this study
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.
Read the detailed description
OBJECTIVES OF STUDY
- To determine the effects of balance training with and without gaze stability exercises on cognitive function in older adults with mild cognitive impairment.
- To determine the effects of balance training with and without gaze stability exercises on balance in older adults with mild cognitive impairment.
- 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
- 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)
- 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)
- 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
- 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)
- 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)
- 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.
- Conditions
- Elderly Population, Cognitive Dysfunction
- Being tested
- Balance training group, Balance training combined with gaze stability exercises
- Keywords
- Balance training, Gaze stability exercises, Dynamic postural stability, Balance, Cognitive function, Older adults
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance training groupProcedure or surgery
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.
Balance training combined with gaze stability exercisesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Balance Training Group | Experimental | 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. Receives: Procedure: Balance training group |
| Balance Training Combined with Gaze Stability Exercises Group | Experimental | 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 Receives: Procedure: Balance training combined with gaze stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 Jul 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PopulationStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will involve two groups. Experimental group involves balance training combined with gaze stability exercises for the treatment of mild cognitive impairment and the control group involves only balance training for the treatment of mild cognitive impairment.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672367
- Sponsor's protocol ID
- FUI/CTR/2024/43
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06672367
- Acronym / sponsor ID
- FUI/CTR/2024/43
- Conditions
- Elderly Population, Cognitive Dysfunction
- Keywords
- Balance training, Gaze stability exercises, Dynamic postural stability, Balance, Cognitive function, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To determine the effects of balance training with and without gaze stability exercises on cognitive function in older adults with mild cognitive impairment.
- To determine the effects of balance training with and without gaze stability exercises on balance in older adults with mild cognitive impairment.
- 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
- 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)
- 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)
- 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
- 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)
- 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)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will involve two groups. Experimental group involves balance training combined with gaze stability exercises for the treatment of mild cognitive impairment and the control group involves only balance training for the treatment of mild cognitive impairment.
| Arm | Type | Receives |
|---|---|---|
| Balance Training Group | Experimental | Procedure: Balance training groupIt 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. |
| Balance Training Combined with Gaze Stability Exercises Group | Experimental | Procedure: Balance training combined with gaze stability exercisesIt 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance training groupIt 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 or surgery | Balance Training Group |
| Balance training combined with gaze stability exercisesIt 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 | Procedure or surgery | Balance Training Combined with Gaze Stability Exercises Group |
Primary outcome
Cognitive function
Time frame: 8 weeks
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
Balance
Time frame: 8 weeks
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.
Dynamic Postural Stability
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training group and Balance training combined with gaze stability exercises in people with Elderly Population and Cognitive Dysfunction, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Nishat, DPT (+923369649611, ayeshanishat015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.