NCT06738823

Brief Summary

THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THE STUDY IS TO DETERMINE THE EFFECT OF WIIFIT TRAINING IN COMPARISON TO VESTIBULAR REHAB TRAINING ON BALANCE IN PATIENTS WITH BENIGN PAROXYSMAL POSITIONAL VERTIGO

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

December 18, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 28, 2024

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Static Balance

    The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is a validated tool used to measure balance 0 means no problem, 100 means severe problem

    6 weeks

  • Vertigo

    DHI scale is used to assess vertigo.The questionnaire consists of 25 items with 3 responses YES= 4 points SOMETIMES = 2 points and NO = 0 points. The total score ranges from 0 to 100, higher score indicating self perceived handicap due to dizziness.

    6 weeks

  • Static Balance

    CTSIB of Biodex is used to assess static balance and has 4 components. a) Firm surface with eyes open; (Mean value 0.44)test the integration of visual,somatosensory and vestibular inputs. All sensory systems are available for balance. b) Firm surface with eyes closed; (mean value 0.80)evaluate the reliance on somatosensory input for balance and visual input is eliminated.c) Foam surface with eyes open; (Mean value; 0.79) Test the ability to use visual and vestibular inputs for balance when somatosensory inputs is unreliable,unstable surface. d) Foam surface with eyes closed; (mean value 2.41) primarily challenges the vestibular system by eliminating visual input and providing unreliable somatosensory feedback. The total mean of these 4 components is 1.11.

    6 weeks

  • Dynamic balance

    Functional Reach test will be used to assess dynamic balance * Scoring: * Distance in centimeters or inches is recorded. * Normal values : * \<15 cm indicates a high fall risk in older adults

    6 weeks

Study Arms (2)

Experimental group A

EXPERIMENTAL

The participants will receive intervention through Wii fit training which includes games tight rope tension, ski slalom, penguin slide, table tilt, and heading for 6 total 6 weeks. 3 days per week session will be given for 30 minutes including 5-minutes warmup and cool down and 5 minutes of break in between to avoid fatigue.

Procedure: INTERVENTION GROUP : TRAINING WITH WIIFIT

Experimental group B

ACTIVE COMPARATOR

The participants will receive vestibular rehabilitation training. The rehabilitation programme will include weight shifting, neck rotations, sit to stand exercises on padded mat, and head movements with eyes closed. The intervention will be given for 3 minutes, 3 days a week for total 6 weeks of time period.

Procedure: VESTIBULAR REHABILITATION TRAINING

Interventions

RCT (RANDOMIZED CONTROL TRIAL) GROUP 1 : Wii FIT TRAINING TIGHT ROPE TENSION, SKI SLALOM, PENGUIN SLIDE, TABLE TILT GROUP 2 : VESTIBULAR REHABILITATION TRAINING WEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED.

Experimental group A

WEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED.

Experimental group B

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with benign paroxysmal positional vertigo.
  • Aged 30-60 years.
  • Ability to stand and walk independently.
  • Male and Female
  • Positive Dix Hallpike Test
  • DHI Scale: 36-42 (moderate Handicap)

You may not qualify if:

  • patients with history of vestibular surgery or cochlear implantation.
  • Patients with history of seizures or epilepsy.
  • patients with a pacemaker or implantable cardioverter-defibrillator(ICD).
  • Patients with history of severe head injury or concussion within the past year.
  • No other vestibular disorders or conditions that may affect balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigo

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 18, 2024

Study Start

July 20, 2024

Primary Completion

December 1, 2024

Study Completion

December 20, 2024

Last Updated

December 18, 2024

Record last verified: 2024-11

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