NCT06797141

Brief Summary

Patients with vestibular disorders often experience cognitive-motor interference which can adversely affect their motor performance, significantly impair daily functioning, increase instability, reducing quality of life and increasing the risk of falls. Vestibular rehabilitation is a well-established therapeutic approach for managing vestibular disorders in reducing symptoms and improving balance and mobility. Similarly, Dual Task Training improves cognitive-motor integration by enhancing both cognitive and motor functions and has shown promising results in other populations. This study is aimed to determine the combined effects of both interventions as it might provide a more comprehensive and effective treatment, ultimately improving patient outcomes and quality of life.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

November 3, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

Vestibular DisordersVestibular RehabilitationDual Task ExercisesQuality of LifeGait

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go test

    The instrument is used to assess dynamic balance including pace, distance, mechanism of turn, type of chair and number of trials. The time required to perform this test is measured. If more than 12 sec is taken in the completion of this test then it indicates high risk of fall

    8 week

  • Dynamic Gait Index

    Dynamic Gait Index (DGI) contains eight items measured on 4-point ordinal scale (3: Normal, 2: Mild Impairment, 1: Moderate impairment, 0: Severe Impairment).

    8 week

  • Vestibular Rehabilitation Benefit Questionnaire

    The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is 22 items subjective tool used to evaluate vestibular symptoms and their impact on quality of life in vestibular disorders. It is categorized into 3 subscales Dizziness and anxiety, Motion-provoked dizziness and Quality of life. Its score interpretation indicates 0%: no deficit \& 100%: significant deficit. Score above 0% signifies the presence of symptoms, loss of function, or reduced quality of life

    8 week

Secondary Outcomes (1)

  • Dizziness Handicap Inventory

    8 week

Study Arms (2)

Vestibular Rehabilitation and Dual Task Training and Traditional Physical Therapy

EXPERIMENTAL

Group A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes. Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks

Other: Vestibular Rehabilitation and Dual task Training and Traditional Physical Therapy

Vestibular Rehabilitation and Traditional Physical Therapy

ACTIVE COMPARATOR

Group B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks.

Other: Vestibular Rehabilitation and Traditional Physical Therapy

Interventions

Group A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes. Treatment session will be given 5 days per week for 8 weeks. Patients will be instructed to perform 2 sets of 5 repetition each Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Dual Task exercises comprising of primary and secondary tasks Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down

Vestibular Rehabilitation and Dual Task Training and Traditional Physical Therapy

Group B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be given 5 days per week for 8 weeks. Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down

Vestibular Rehabilitation and Traditional Physical Therapy

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complaining of dizziness for longer than 3 months
  • Patients with history of at least 1 bout of dizziness per month
  • Patients with history of at least 1 fall in previous 6 months
  • Diagnosed Patients as having vestibular disorder by an otolaryngologist
  • Mini Mental State Examination (MMSE) score greater than 24

You may not qualify if:

  • Patients with Meniere disease and bilateral vestibular disorders
  • Patients with central nervous system disorders, and psychiatric disorders
  • Patients having visual impairment that could not be treated with lenses or glasses
  • Dizziness not resulting from vestibular disorder or use of Medication for Dizziness
  • Movement limitation due to orthopedic problems
  • Those who were unable to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Memorial Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

Related Publications (4)

  • Choi WY, Gold DR. Vestibular Disorders: Pearls and Pitfalls. Semin Neurol. 2019 Dec;39(6):761-774. doi: 10.1055/s-0039-1698752. Epub 2019 Dec 17.

    PMID: 31847047BACKGROUND
  • Aedo-Sanchez C, Riquelme-Contreras P, Henriquez F, Aguilar-Vidal E. Vestibular dysfunction and its association with cognitive impairment and dementia. Front Neurosci. 2024 Mar 27;18:1304810. doi: 10.3389/fnins.2024.1304810. eCollection 2024.

    PMID: 38601091BACKGROUND
  • Strupp M, Dlugaiczyk J, Ertl-Wagner BB, Rujescu D, Westhofen M, Dieterich M. Vestibular Disorders. Dtsch Arztebl Int. 2020 Apr 24;117(17):300-310. doi: 10.3238/arztebl.2020.0300.

    PMID: 32530417BACKGROUND
  • Staab JP. Persistent Postural-Perceptual Dizziness. Semin Neurol. 2020 Feb;40(1):130-137. doi: 10.1055/s-0039-3402736. Epub 2020 Jan 14.

    PMID: 31935771BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Hira Jabeen, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

January 28, 2025

Study Start

November 1, 2024

Primary Completion

March 1, 2025

Study Completion

July 1, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations