NCT06637566

Brief Summary

Vertigo is among the most prevalent disorder in older adults around the world leads to dizziness and balance problems resulting in decreased quality of life. Brandt daroff exercises can accelerate vertigo recovery and prevent recurrence without taking drugs. Cawthorne Cooksey first presented vestibular exercises to improve neurophysiological habituation, improves balance in the elderly. This study aims to determine the effects of brandt daroff exercises with cawthorne cooksey exercises on balance, dizziness and functional parameters in older adults 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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 8, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 10, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

Vertigo,balancefunctional parametersdizziness,

Outcome Measures

Primary Outcomes (3)

  • Dizziness Handicap Inventory:

    Dizziness Handicap Inventory (DHI) Scale is used for assessment of dizziness. DHI is 25-item self-report questionnaire that measures the impact of dizziness on a person's daily life and use as screening as well as outcome measuring tool in vertigo patients. Each item on the DHI is scored on a 0 to 4 scale, with 0 meaning "no problem" and 4 meaning "severe problem." It is a widely used tool in clinical practice to assess the severity of dizziness and its effect on a person's functional, emotional, and physical well-being. DHI has been found to have 75% sensitivity. The DHI Scale has been found to have high test-retest reliability (icc0.92) and moderate construct validity (Pearson's correlation coefficient 0.47). It is a self-report questionnaire so no special equipment is required to perform it.

    6 weeks

  • Tinetti Performance Oriented Mobolity Assessment

    Tinneti POMA (performance oriented mobility assessment) is a reliable tool use for assessment of balance and gait in older adults. The test and retest values for the POMA-T, POMA-B, POMA-G all varied between (0.72) and (0.86). The inter-rater reliability values all varied between (0.80) and (0.93). This test has a sensitivity of 70% and a specificity of 52%. It is a 17-item test that takes about 15 minutes to complete. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totaling 28. Equipment Required: A hard armless chair, A stopwatch, A 15 feet even and uniform walkway.

    6 weeks

  • Lawton Instrumental Activities of Daily Living (IADL) Scale

    The Lawton Instrumental Activities of Daily Living (IADL) Scale is used to evaluate independent living skills. The instrument is most useful for identifying how a person is functioning and identifying improvement or deterioration over time. The scale measures eight domains of function including food preparation, housekeeping, laundering. Individuals are scored according to their highest level of functioning in that category. A summary score ranges from 0(low function, dependent) to 8(high function, independent). Inter-rater reliability was established at.85. Administration time is10-15 minutes

    6 weeks

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

They receive brandt daroff exercises with cawthorne cooksey exercises.

Other: Brandt Daroff exercises along with Cawthorne Cooksey exercises

Control Group

OTHER

They receive brandt daroff exercises only.

Other: Brandt Daroff exercises

Interventions

Brandt Daroff exercises along with Cawthorne Cooksey exercises. The Cawthorne Cooksey exercises include eye and head movements, coordination of eye and head movements (visual-vestibular interaction), postural control exercises, and progressively more difficult balance tasks (eyes open, eyes closed, large base support, uneven base support, while walking, in high visual or noisy environments). Exercises should be done three times a day, with 5 repetitions of each. The exercises will be performed in three sessions per week with 60 minutes each session for eight weeks. The cawthorne Cooksey exercises includes the following: A: Eye and head movement B: Head and body movement, sitting down: C: Standing up exercises:

Experimental Group

brandt daroff exercises without cawthorne Cooksey exercises. To begin the Brandt-daroff exercise, the patient will sit and swivel the head 45 degrees to one side (left), then instantly lie down on the other shoulder (right). The patient should be instructed to maintain this posture for 30 seconds or until the vertigo subsides. The patient then gradually returns to the starting position, maintaining the left ear rotation until sat upright. Following the same 30 second time limits, the patient turns his head in the opposite way (right) and rests down on the opposite shoulder (left). These exercises will be instructed to perform at home for 3 sets (morning, afternoon and evening) with 5 repetitions approximately for 30 minutes in each session for five weeks

Control Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older adults 65or above.
  • Both Male and Female.
  • Symptoms suggested vertigo, confirmed by neurologist.
  • Accepted to participate in study.
  • DHI Scale: 36-42 (moderate handicap).

You may not qualify if:

  • Patients having balance issues other than dizziness and vertigo.
  • Middle or external ear diseases.
  • Cerebrovascular diseases.
  • Feet injuries including severe bruises, ulcers, open wounds or recent burns.
  • Neck pain and cervical spine disease.
  • History of serious musculoskeletal disease (arthritis, Alzheimer's disease, intervertebral disc degeneration).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Hospital Joharabad

Jauharabad, Punjab Province, 41200, Pakistan

Location

Related Publications (2)

  • Teixido M, Casserly R, Melley LE. Lateral Modified Brandt-Daroff Exercises: A Novel Home Treatment Technique for Horizontal Canal BPPV. J Int Adv Otol. 2021 Jan;17(1):52-57. doi: 10.5152/iao.2020.9452.

    PMID: 33605222BACKGROUND
  • Zamyslowska-Szmytke E, Politanski P, Jozefowicz-Korczynska M. Dizziness Handicap Inventory in Clinical Evaluation of Dizzy Patients. Int J Environ Res Public Health. 2021 Feb 24;18(5):2210. doi: 10.3390/ijerph18052210.

    PMID: 33668099BACKGROUND

MeSH Terms

Conditions

VertigoDizziness

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Muhammad Asrar Yousaf, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

October 8, 2024

Primary Completion

December 15, 2024

Study Completion

January 3, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations