NCT06407726

Brief Summary

To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

Study Start

First participant enrolled

May 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

May 6, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

Old AgeVestibular DisorderBalanceExercise

Outcome Measures

Primary Outcomes (3)

  • The Dynamic Gait Index (DGI)

    The Dynamic Gait Index (DGI) is a clinical tool assessing balance during walking under different external conditions. It uses a four-point ordinal scale, with a total score of 24. Scores below 19 indicate a higher risk of falls in older adults, while scores above 22 suggest safe ambulation. The DGI has demonstrated validity as a measure of functional mobility and strongly predicts falls

    6 months

  • Berg Balance Scale

    Berg Balance Scale: is a clinical tool assessing static and dynamic balance through 14 functional tasks, each scored from 0 to 4, with a maximum score of 56. Scores below 45 indicate a higher risk of falling. It has demonstrated excellent validity, correlating well with the Timed Up-and-Go test. It also exhibits excellent test-retest reliability, making it a widely accepted tool for measuring balance and mobility.

    6 months

  • Modified Barthel Index

    Modified Barthel Index is widely accepted measure of physical disability, assessing activities of daily living. Scoring ranges from 0 to 20, with lower scores indicating increased disability. The total score reflects the patient's independence in daily activities, with changes of more than two points indicating a probable genuine change. The index has demonstrated validity, with scores between 0.73 and 0.77 compared to a motor ability index for stroke patients.It also exhibits high inter-rater and test-retest reliability,Higher scores indicates maximum recovery

    6 months

Study Arms (2)

participants will receive Virtual Reality intervention with conventional treatment,

EXPERIMENTAL

Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy.

Other: virtual reality training group

participants will receive Vestibular Exercises with conventional treatment.

ACTIVE COMPARATOR

Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.

Other: vestibular exercise group

Interventions

Participants will receive 40-minute sessions five days per week for six weeks of Virtual Reality intervention and conventional therapy.

participants will receive Virtual Reality intervention with conventional treatment,

Participants will receive 40-minute sessions five days per week for six weeks of Vestibular Exercises and conventional therapy.

participants will receive Vestibular Exercises with conventional treatment.

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults with or without any assistive device.
  • Participants with a Mini-Mental State Examination score greater than 24.
  • Participants with a value greater than 10 secs on the Time Up and Go Test.

You may not qualify if:

  • Severe visual or vestibular impairments (e.g., Meniere's disease, labyrinthitis).
  • Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
  • Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
  • History of epilepsy or seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Fedral, 44000, Pakistan

Location

Related Publications (3)

  • Tornero-Quinones I, Saez-Padilla J, Espina Diaz A, Abad Robles MT, Sierra Robles A. Functional Ability, Frailty and Risk of Falls in the Elderly: Relations with Autonomy in Daily Living. Int J Environ Res Public Health. 2020 Feb 5;17(3):1006. doi: 10.3390/ijerph17031006.

    PMID: 32033397BACKGROUND
  • Nobrega-Sousa P, Gobbi LTB, Orcioli-Silva D, Conceicao NRD, Beretta VS, Vitorio R. Prefrontal Cortex Activity During Walking: Effects of Aging and Associations With Gait and Executive Function. Neurorehabil Neural Repair. 2020 Oct;34(10):915-924. doi: 10.1177/1545968320953824. Epub 2020 Aug 31.

    PMID: 32865134BACKGROUND
  • Lockie RG, Dawes JJ, Kornhauser CL, Holmes RJ. Cross-Sectional and Retrospective Cohort Analysis of the Effects of Age on Flexibility, Strength Endurance, Lower-Body Power, and Aerobic Fitness in Law Enforcement Officers. J Strength Cond Res. 2019 Feb;33(2):451-458. doi: 10.1519/JSC.0000000000001937.

    PMID: 28445229BACKGROUND

MeSH Terms

Conditions

Vestibular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesBehavior

Study Officials

  • Zeest hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations