CClinicalTrials.gg
Status unknownNCT04283279Updated Feb 25, 2020

Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study

An interventional study of Virtual reality exercise and Vestibular rehabilitation exercise in Hearing Loss, Gait, Unsteady and Balance; Distorted, sponsored by Western Norway University of Applied Sciences. Status unknown. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Western Norway University of Applied Sciences · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

Hearing impairment is common in older adults, and recent research points to associations between hearing impairment and balance/mobility. The association may be due to more attentional resources being used to compensate for the sensory loss, with less resources available for maintaining balance. The aim of this projects is therefore to investigate whether an exercise program with focus on motor-cognitive tasks is feasible for older adults with hearing impairment. The study is meant as a proof-of-concept study, where trialling will be evaluated, and results will be used to inform the design of a larger and adequately powered study.

Read the detailed description

Study design:

This is an experimental (exercise) study with follow-ups three and twelve months after exercise completion.

Participants:

Participants will be recruited from two instances:

  • "Praksisnett", which is a collaboration between GPs and researchers in Bergen, Norway, where GPs recruit potential participants to research projects.
  • The Ear, Nose, Throat department at Haukeland University Hospital (Bergen), who provide service to older adults with hearing impairment. The aim is to include 60 patients into three intervention arms: i) virtual reality exercises, ii) vestibular rehabilitation exercises and usual care

Intervention arms:

  • Virtual reality exercises: Participants will exercise in virtual environments twice weekly. The choice of environments/tasks will be individualized, and progress from sitting/standing exercises, to doing exercises while walking on a treadmill. The aim is to perform cognitive and motor tasks simultanously.
  • Vestibular rehabilitation exercises: This is an exercise approach that has been used in clinical groups, such as patients with vestibular disorders and traumatic brain injury. The aim is to perform movements/exercises where the participant is exposed gradually to movements that may be provocative for the vestibular system.

The exercises will be done in a movement lab at Western Norway University of Applied Sciences. Participants will be randomised to either of the three intervention arms using a computerized procedure. Neither participants, testers or deliverers of the intervention will be blinded. Testers and intervention deliverers will be physiotherapists, students enrolled in a master program in clinical physiotherapy and bachelor students in physiotherapy.

02

Conditions studied

  • Hearing Loss
  • Gait, Unsteady
  • Balance; Distorted
  • Old Age; Debility
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Western Norway University of Applied Sciences is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hearing threshold above 30 dB

Exclusion criteria

Exclusion Criteria:

  • Inability to give informed consent,
  • Inability to speak Scandinavian languages or English
  • Diseases with severe motor impairments (such as mb Parkinsons)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Virtual reality exercise

    20 participants will be randomised to this arm

    Other: Virtual reality exercise

  • Experimental
    Vestibular rehabilitation exercise

    20 participants will be randomised to this arm

    Other: Vestibular rehabilitation exercise

  • Other
    Control

    20 participants will be randomised to this arm

    Other: Control

Interventions

  • OtherVirtual reality exercise

    Participants will do exercises in a virtual environment, solving tasks that require cognitive efforts and motor/balance efforts. The virtual environment/tasks will be delivered through a head-mounted display ("goggles"). Difficulty will progress from standing/sitting, to walking on a treadmill. The environments that will be used will be both over-the-counter environments, as well as in-house designed environments.

  • OtherVestibular rehabilitation exercise

    Vestibular rehabilitation exercises focus on head and eyes movements, as well as whole-body movements. The aim is to facilitate the use of other sensory organs than the vestibular organs, which will also be relevant to persons who are not receiving sufficient sensory information from the auditory system. The exercises will progress as tolerated, under careful supervision of trained therapists.

  • OtherControl

    Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active

06

What researchers measure

Primary outcomes

  1. Short physical performance battery

    Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.

    Time frame: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention

Secondary outcomes

  1. Standing balance - posturography

    Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface

    Time frame: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention

  2. Walking balance

    Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness

    Time frame: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention

  3. The World Health Organisation Disability Assessment Schedule (WHODAS)

    Questionnaire that registers disability across several domains. Possible score range is 0-144, where lower values indicate less disability

    Time frame: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention

Other outcomes

  1. Activity monitoring

    Participants will wear sensors over 4 days, registering activity in their own environments

    Time frame: Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)

  2. Dizziness Handicap Inventory

    25 item-questionnaire that registers limitations due to dizziness. Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.

    Time frame: Measured at baseline/before intervention and after intervention (6 weeks after baseline)

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04283279
Lead sponsor
Western Norway University of Applied Sciences
Collaborators
Haukeland University Hospital, University of Dublin, Trinity College
Responsible party
Bård Bogen (Associate professor, Western Norway University of Applied Sciences) — Principal investigator
First posted
Feb 25, 2020
Start date
May 1, 2020 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Feb 25, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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