NCT06760975

Brief Summary

The aim of this study is to determine the comparative effects of vestibular Habituation and ocular reflex exercises on Gait stability, Dizziness severity, and fear of fall in elderly population with vertigo

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

December 31, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 1, 2025

Last Update Submit

January 1, 2025

Conditions

Keywords

vertigoHabituationOcular reflexFear of fallGait stability

Outcome Measures

Primary Outcomes (3)

  • Dynamic gait index

    The DGI is used for gait assessment and has 8 items. The scoring of DGI is based on 4 point scale ranging from 0-3 while 0 indicates severe impairment and 3 indicates normal ability. DGI proves to be reliable and valid for older people. Total score for best performance is 24 and low score on DGI indicates greater impairment in functional mobility.

    6 weeks

  • FES-I Fall efficacy scale international

    FES-I scale is used to access fear of fall and is consist of 16 items questionnaire allows participants to rate their fear of falling during specific activities at the rate of four different intensities ranging from "not at all concerned to vary concerned". Higher scores indicates a more significant fear of falling. score range from 16-19 show low concern of falling. Score ranges from 20-27 shows moderate concern and score ranges from 28-64 show high concern of fall to daily Activities.

    6 weeks

  • Dizziness Handicap inventory

    The DHI is used to access dizziness and is consist of 25 items. Each item is answered with No (0) points sometimes (2) points or Yes (4) points. Scoring of DHI ranges from 0 to 100. further divided into physical (28) points , functional (36) points and emotional (36) points. The higher the scores result in perceived handicap. Moreover (DHI) proved to be a reliable instument

    6 weeks

Study Arms (2)

GROUP A Vestibular Habituation Exercises

EXPERIMENTAL

Group A will receive 24 sessions of vestibular habituation exercises, delivered 4 times weekly for six weeks, each session lasting 30 minutes. Effects will be measured at baseline, in the 3rd week, post-intervention, after six weeks, and at a 9th-week follow-up.

Other: Vestibular Habituation Exercises

GROUP B Ocular Reflex exercises

EXPERIMENTAL

Group B will receive ocular reflex exercises. A total of 24 sessions (4x/week for 6 weeks) will be conducted , lasting 50-60 minutes each. The effects will be measured at baseline, in the 3rd week, post intervention, after six weeks, and at a 9th-week follow-up.

Other: Ocular Reflex Excercises

Interventions

The vestibular habituation exercise group follows a structured progression over six weeks. in week 1 participants perform large amplitude, rapid cervical rotations seated, completing 3 sets of five cycles each. By week 2, the exercises increase in complexity , incorporates standing pivots or seated trunk flexion extension. in week 3 the cervical rotations are continued with seated or standing posture. week 4 introduces a busy visual background during the exercise to challenge visual-vestibular integration. In week 5 the exercises are performed standing with the addition complex visual target against a busy background. finally week 6 includes most advance movement including standing pivots 180 degrees and brand-daroff exercises with further visual challenges of near and far targets in busy background. Each exercise session last for 2 minutes and is aimed at progressively enhancing vestibular processing and adaptability.

GROUP A Vestibular Habituation Exercises

The Ocular reflex exercises focuses on enhancing visual tracking and reflexes through targeted viewing exercises. In week 1, participants perform horizontal and vertical X1 viewing exercises with a near target, holding each position for 1 minute while seated. In week 2 the duration of the X1 exercises is extended to 2 minutes with the near target still in seated position. Week 3 shift to a far target for the X1 exercises and the participants performs them while standing increasing the challenge. By week 4 the exercise incorporate both near and far target in front of a busy background. extending the duration to 2 minutes while standing. In week 5 horizontal and vertical X2 viewing exercises are added with a plain background, while still using near and far targets in front of a busy background . finally week 6 continues the X1 and X2 exercises with near and far targets in a busy background, performed for 2 minutes while standing. This aims to improve visual tracking.

GROUP B Ocular Reflex exercises

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Both male and female patients
  • Age 65-75
  • patient with vestibular disorder for at least 6 months
  • patient with unspecific dizziness sensation for at least 3 months
  • Dizziness handicap inventory score \> 16 -

You may not qualify if:

  • patient with central nervous system diseases, like stroke, multiple sclerosis, Parkinson's disease.
  • orthopedic problems that precluded performance of the exercises
  • systemic diseases with no medication control
  • if patient were legally blind or had dementia
  • patient with no history of epilepsy and other neurological diseases -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rasheed Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

Services Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (6)

  • Bayat A, Pourbakht A, Saki N, Zainun Z, Nikakhlagh S, Mirmomeni G. Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. Iran Red Crescent Med J. 2012 Nov;14(11):705-8. doi: 10.5812/ircmj.3507. Epub 2012 Nov 15.

    PMID: 23396380BACKGROUND
  • Balatsouras DG, Koukoutsis G, Fassolis A, Moukos A, Apris A. Benign paroxysmal positional vertigo in the elderly: current insights. Clin Interv Aging. 2018 Nov 5;13:2251-2266. doi: 10.2147/CIA.S144134. eCollection 2018.

    PMID: 30464434BACKGROUND
  • Cohen HS, Kimball KT. Increased independence and decreased vertigo after vestibular rehabilitation. Otolaryngol Head Neck Surg. 2003 Jan;128(1):60-70. doi: 10.1067/mhn.2003.23.

    PMID: 12574761BACKGROUND
  • 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
  • Norre ME, Beckers A. Vestibular habituation training: exercise treatment for vertigo based upon the habituation effect. Otolaryngol Head Neck Surg. 1989 Jul;101(1):14-9. doi: 10.1177/019459988910100104.

    PMID: 2502758BACKGROUND
  • Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.

    PMID: 19629221BACKGROUND

MeSH Terms

Conditions

VertigoSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Hira Jabeen, MS-NMPT

    Riphah International University

    STUDY CHAIR

Central Study Contacts

Hira Jabeen, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as Assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

December 31, 2024

Primary Completion

July 31, 2025

Study Completion

August 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations