NCT06672367

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 31, 2024

Last Update Submit

October 31, 2024

Conditions

Elderly PopulationCognitive Dysfunction

Keywords

Balance trainingGaze stability exercisesDynamic postural stabilityBalanceCognitive functionOlder adults

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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.

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

Procedure: Balance training combined with gaze stability exercises

Interventions

Balance training groupPROCEDURE

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 Group
Balance training combined with gaze stability exercisesPROCEDURE

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

Balance Training Combined with Gaze Stability Exercises Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Ayesha Nishat, DPT

CONTACT

+923369649611ayeshanishat015@gmail.com

Study Design

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

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 4, 2024

Study Start

July 15, 2024

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations

PA(1)