NCT04751006

Brief Summary

Effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patients with chronic dizziness: A Randomized Controlled Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

February 10, 2021

Last Update Submit

February 10, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Scale

    Balance was measured using Berg Balance Scale

    6 Weeks

  • Disability Handicapped Inventory

    Precieved Disability was measured using Disability Handicapped Invertory

    6 Weeks

  • Activity Specific Balance Confidence

    Risk of Fall Prevention was measured using Activity Specific Balance Confidence

    6 Weeks

Study Arms (2)

Gaze Group

EXPERIMENTAL

Participants performed balance training with gaze stabilization exercises

Other: Gaze Stabilization Exercises

Control Group

OTHER

Participants performed balance training with saccade eye exercises

Other: Balance Training

Interventions

Gaze group performed balance exercises with gaze stability exercise.Gaze stability exercises included two types of exercises vestibular adaptation and substitution exercises. In Adaptation exercises individual need to fixate on a visual target during horizontal and vertical head movement with a purpose of increasing gaze stability and a long term gain to vestibular system. Subsitution exercises are planned to use other eye movement stratigies to substitute vestibular function and sustained visual fixation. During Substitution exercises individual need to perfomed eye head movement between target with a purpose of clear sighting during these tasks. Balance exercises consist of both static and dynamic balance exercises with weekly progression making balance exercises more challenging.

Gaze Group

Participants performed balance training with saccade eye exercises.balance exercises included both static and dynamic balance exercises with a purpose of increasing mobility and stability of a posture by weekly progression. These exercises included standing on firm and foam surface with eyes open or close, heel stand, toe stand, marching on firm surface, forward and backward walking with normal base of support with weekly progression. Each task was performed for 5 repetitions with weekly progression in each task.

Control Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Geriatric population
  • Both Gender
  • H/O chronic dizziness with normal vestibular function
  • H/O age related balance impairment
  • H/O impaired balance having a Berg Balance Scale (BBS) score between 35-45
  • Participant have sufficient cognitive and communication skills

You may not qualify if:

  • H/O insufficient communication skills to follow instructions
  • H/O impaired vestibular function
  • H/O Visual impairment
  • H/O Severe hearing loss
  • H/O mental disorder that could restrains the ability to concentrate during therapy
  • H/O Other systematic diseases
  • Any history of marked musculoskeletal impairment, lower limb injury, surgery other than age related changes and balance disorder due to other neurological conditions like Parkinsonism, stroke, multiple sclerosis etc. were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy Of Lahore

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (4)

  • Geraghty AWA, Essery R, Kirby S, Stuart B, Turner D, Little P, Bronstein A, Andersson G, Carlbring P, Yardley L. Internet-Based Vestibular Rehabilitation for Older Adults With Chronic Dizziness: A Randomized Controlled Trial in Primary Care. Ann Fam Med. 2017 May;15(3):209-216. doi: 10.1370/afm.2070.

    PMID: 28483885BACKGROUND
  • Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.

    PMID: 20588090BACKGROUND
  • Jahn K. The Aging Vestibular System: Dizziness and Imbalance in the Elderly. Adv Otorhinolaryngol. 2019;82:143-149. doi: 10.1159/000490283. Epub 2019 Jan 15.

    PMID: 30947233BACKGROUND
  • Maciaszek J, Osinski W. Effect of Tai Chi on body balance: randomized controlled trial in elderly men with dizziness. Am J Chin Med. 2012;40(2):245-53. doi: 10.1142/S0192415X1250019X.

Study Officials

  • Syeda Nida Fatima

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 11, 2021

Study Start

March 5, 2020

Primary Completion

December 5, 2020

Study Completion

December 8, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Results of study

Locations