NCT04413084

Brief Summary

There is a need to manage dizziness in vestibular dysfunction patients with the vestibular rehabilitation to improve the life style of these patients. Vestibular rehabilitation exercises are beneficial for the vestibular dysfunction patients because they decrease dizziness and visual symptoms, increase walking and balance functions and with this the general activity level also increases. In my study my goal is to apply two different vestibular exercise and check their effects on dizziness in hearing impaired children's.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

April 14, 2020

Last Update Submit

March 6, 2021

Conditions

HEARING IMPAIRED CHILDREN

Keywords

DizzinessHearing Impaired childrenVestibular rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Dix Hall Pike Test

    The Dix hall pike test is a diagnostic procedure. When performing the test, patients are lowered quickly to supine position with 30 degrees neck extension below horizontal by the clinician. Positive test is reported when the patients report of a production of vertigo and observation of nystagmus.

    Change from Baseline dizziness and balance to 2 Weeks

  • Fukuda Step Test

    A vestibulospinal test, fukuda test is used to measure asymmetrical labyrinthine function. One's ability to step in place with eyes closed without turning depends on normal vestibulospinal and proprioceptive function.

    Change from Baseline dizziness to 2 Week

  • Motion Sensitivity Quotient

    Motion Sensitivity Quotient: is a clinical protocol designed to measure motion provoked dizziness during a series of quick changes to head or body position. Test is used as a guide for exercise developing for the patients problems with the motion provoked dizziness, also for the effectiveness of rehabilitation therapy

    Change from Baseline dizziness to 2 Week

Secondary Outcomes (2)

  • Dizziness Handicap Inventory

    Change from Baseline dizziness to 2 Week

  • Sharpened Romberg's Test

    Change from Baseline balance to 2 Week

Study Arms (2)

Gaze stability exercises

EXPERIMENTAL

Group I will receive Gaze stability exercises.

Other: Gaze stability exercises

Brandt-Daroff Exercises

EXPERIMENTAL

Group II will receive Brandt-Daroff Exercises.

Other: Brandt-Daroff Exercises

Interventions

Gaze stability exercisesOTHER

Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.

Gaze stability exercises
Brandt-Daroff ExercisesOTHER

Brandt-Daroff Exercises 1. Start sitting upright on the edge of the bed. 2. Turn your head 45 degrees to the left, or as far as is comfortable. 3. Lie down on your right side. 4. Remain in this position for 30 seconds or until any dizziness has subsided. 5. Sit up and turn head back to center. 6. Turn your head 45 degrees to the right, or as far as is comfortable. 7. Lie down on your left side. 8. Remain in this position for 30 seconds or until any dizziness has subsided. 9. Sit up and turn head back to center.

Brandt-Daroff Exercises

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with hearing impairment of both genders, those diagnosed with vestibular dysfunction by ear nose and throat specialist.
  • Bilateral hearing loss
  • Mild to moderate hearing loss
  • Age between 8 to 17 years.
  • Any test of the following four tests positive (Dix Hall Pike test, Supine Roll's test, Fukuda Stepping Test and Sharpened Romberg's test) were included in the study

You may not qualify if:

  • Children receiving some other form of treatment for vestibular dysfunction.
  • Suffering from other systemic disorders.
  • Musculoskeletal disorders like fractures, strains, sprains leading to imbalance, central or peripheral neurologic diseases leading to disturbed balance.
  • Those who were handicapped were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

. National Special Education Center Muzaffarabad department of social welfare & women development.

Muzaffarabad, Azad Kashmir, 13100, Pakistan

Location

Related Publications (5)

  • Khandare S, Gonsalves N, Palekar DT, Rathi DM, Desai R, Deshmukh MJIJoCRiLS. Efficacy of two different vestibular rehabilitation approaches for dizziness in vestibular dysfunction in hearing impaired children". 2018;7(05):1985-8.

    BACKGROUND

  • Hsiao CJ, Cherry DK, Beatty PC, Rechtsteiner EA. National Ambulatory Medical Care Survey: 2007 summary. Natl Health Stat Report. 2010 Nov 3;(27):1-32.

    PMID: 21089986BACKGROUND

  • Lakhani H, Saxena PP, Shethia UJp. Effectiveness of Brandt-daroff exercises on hearing impaired children: A Comparative Study.2:100.

    BACKGROUND

  • 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

  • Suarez H, Angeli S, Suarez A, Rosales B, Carrera X, Alonso R. Balance sensory organization in children with profound hearing loss and cochlear implants. Int J Pediatr Otorhinolaryngol. 2007 Apr;71(4):629-37. doi: 10.1016/j.ijporl.2006.12.014. Epub 2007 Feb 2.

    PMID: 17275927BACKGROUND

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 14, 2020

First Posted

June 2, 2020

Study Start

August 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 15, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)