NCT04261283

Brief Summary

In this research, the main purpose is to determine the effects of Circuit Training consisting of Structured Vestibular rehabilitation Program under the strict supervision of Neuro-Therapist versus Medicines and General (simple) Rehabilitation (only Home-based) in community-dwelling population of people diagnosed with Vestibular disorders. A booklet consisting of general instructions, simple vestibular exercises which are to be made a part of daily routine, specific diet plan and specific precautions to be taken by patients reporting with vertigo, oscillopsia and dizziness will also be provided to all the patients. This is a community service addition, added so that everyone in the society can have easy access to the instructions, will be cost effective, and will reduce their visits to the therapist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 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

December 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

December 18, 2019

Last Update Submit

March 29, 2021

Conditions

Keywords

DizzinessExerciseVestibularVertigo

Outcome Measures

Primary Outcomes (3)

  • Visual Vertigo Analogue Scale

    changes from the baseline,this scale is used to measure the intensity of symptoms, 0-10 cm line zero anchor representing no dizziness and 10 anchor representing extreme dizziness or activity avoided due to dizziness

    4 week

  • Vertigo Handicap Questionnaire

    changes from the baseline, this scale is used to assess the disability level in vestibular impairment. 25 Items measuring Four dimensions(restriction of Activity, social Anxieties, fear of Vertigo, severity of episodes). Item scaling is on 5 points likert scale from 0 (no handicap) to 4 (maximum handicap)

    4 week

  • Dizziness Handicap Inventory

    changes from the baseline, this test is used to determine the physical, functional and emotional components of Dizziness. Item Scores are summed, there is a maximum score of 100 (28 points for physical, 36 for emotional and 36 for functional and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness. Answers are graded: 0 (no), 2 (sometimes), 4 (Yes)

    4 week

Secondary Outcomes (2)

  • Vestibular Disorders Activities of Daily Living Scale

    4 week

  • Berg Balance Scale

    4 week

Study Arms (2)

Circuit Training

EXPERIMENTAL

Specific exercise are designed in circuit training

Other: Experimental

Control Group

ACTIVE COMPARATOR

Conventional treatment

Other: Active Comparator

Interventions

The Circuit Training will be consisting of: 1. Habituation Exercises 2. Exercises for the gaze stability (The two exercises are specifically for the patients who reported a high score on oscillopsia severity questionnaire 3. Exercises to improve Saccade Latency. 4. Adaptation Exercises 5. Substitution Exercises 6. Postural Control Exercises 7. General Conditioning Activities 8. Cawthorne-Cooksey Exercises 9. Ocular Motor Exercises 10. Gait Exercises 11. Treatment to Decrease Sensitivity to Motion in the Environment

Circuit Training

Medicines as prescribed by the ear, nose, and throat (ENT) specialist and Home-based exercise Programme (Simple and general vestibular rehabilitation exercises) will be recommended to the patients to perform. ( Not under the supervision of neuro-therapist)

Control Group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients diagnosed with Vestibular Disorders/
  • patient with Dysfunctions by ENT specialist.

You may not qualify if:

  • Patients diagnosed with BPPV.
  • Central nervous system (CNS) involvement (significant neurological disorders)
  • Musculoskeletal (MSK) system deficits (orthopedic disorders)
  • Uncontrolled hypertension (HTN)
  • Heart diseases
  • Psychosocial abnormalities
  • Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (4)

  • Johansson M, Akerlund D, Larsen HC, Andersson G. Randomized controlled trial of vestibular rehabilitation combined with cognitive-behavioral therapy for dizziness in older people. Otolaryngol Head Neck Surg. 2001 Sep;125(3):151-6. doi: 10.1067/mhn.2001.118127.

    PMID: 11555746BACKGROUND
  • Herdman SJ, Blatt PJ, Schubert MC. Vestibular rehabilitation of patients with vestibular hypofunction or with benign paroxysmal positional vertigo. Curr Opin Neurol. 2000 Feb;13(1):39-43. doi: 10.1097/00019052-200002000-00008.

    PMID: 10719648BACKGROUND
  • Giray M, Kirazli Y, Karapolat H, Celebisoy N, Bilgen C, Kirazli T. Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. Arch Phys Med Rehabil. 2009 Aug;90(8):1325-31. doi: 10.1016/j.apmr.2009.01.032.

    PMID: 19651266BACKGROUND
  • Kristiansen L, Magnussen LH, Juul-Kristensen B, Maeland S, Nordahl SHG, Hovland A, Sjobo T, Wilhelmsen KT. Feasibility of integrating vestibular rehabilitation and cognitive behaviour therapy for people with persistent dizziness. Pilot Feasibility Stud. 2019 May 20;5:69. doi: 10.1186/s40814-019-0452-3. eCollection 2019.

    PMID: 31139431BACKGROUND

MeSH Terms

Conditions

Vestibular DiseasesDizzinessMotor ActivityVertigo

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorNervous System Diseases

Study Officials

  • Arshad Nawaz AN Malik, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Coding will be used and assessor will not have access to treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

February 7, 2020

Study Start

July 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Later on will be publish

Locations