Hearing LossNCT04283279
Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
A study testing Virtual reality exercise and Vestibular rehabilitation exercise in people with Hearing Loss and Gait, Unsteady, run by Western Norway University of Applied Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hearing Loss, Gait, Unsteady, Balance; Distorted
- What is being tested?
- Virtual reality exercise and Vestibular rehabilitation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hearing threshold above 30 dB
Who cannot join
- Inability to give informed consent,
- Inability to speak Scandinavian languages or English
- Diseases with severe motor impairments (such as mb Parkinsons)
About this study
Official title: Balance and Mobility in Older Adults With Hearing Impairment
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.
- Conditions
- Hearing Loss, Gait, Unsteady, Balance; Distorted, Old Age; Debility
- Being tested
- Virtual reality exercise, Vestibular rehabilitation exercise, Control
- Medical subject headings
- Hearing Loss, Gait Disorders, Neurologic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exerciseOther
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.
Vestibular rehabilitation exerciseOther
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.
ControlOther
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality exercise | Experimental | 20 participants will be randomised to this arm Receives: Other: Virtual reality exercise |
| Vestibular rehabilitation exercise | Experimental | 20 participants will be randomised to this arm Receives: Other: Vestibular rehabilitation exercise |
| Control | Other | 20 participants will be randomised to this arm Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short physical performance battery
Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.
Measured: 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 (3)
Standing balance - posturography
Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface
Measured: 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
Walking balance
Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University of Dublin, Trinity College
- Responsible party
- Principal investigator, Bård Bogen, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283279
- Sponsor's protocol ID
- 2019/FO243016
- Status last verified
- Feb 2020
- First submitted
- 22 Dec 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Mobility in Older Adults With Hearing Impairment
- ClinicalTrials.gov ID
- NCT04283279
- Acronym / sponsor ID
- 2019/FO243016
- Conditions
- Hearing Loss, Gait, Unsteady, Balance; Distorted, Old Age; Debility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University of Dublin, Trinity College
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality exercise | Experimental | Other: Virtual reality exercise20 participants will be randomised to this arm |
| Vestibular rehabilitation exercise | Experimental | Other: Vestibular rehabilitation exercise20 participants will be randomised to this arm |
| Control | Other | Other: Control20 participants will be randomised to this arm |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Hearing threshold above 30 dB
Key exclusion criteria (3 listed)
- Inability to give informed consent,
- Inability to speak Scandinavian languages or English
- Diseases with severe motor impairments (such as mb Parkinsons)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exerciseParticipants 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. | Other | Virtual reality exercise |
| Vestibular rehabilitation exerciseVestibular 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. | Other | Vestibular rehabilitation exercise |
| ControlParticipants will not be randomised to either of the exercise interventions, but will be adviced to stay active | Other | Control |
Primary outcome
Short physical performance battery
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
Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.
3 secondary outcomes
Standing balance - posturography
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
Walking balance
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
The World Health Organisation Disability Assessment Schedule (WHODAS)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exercise and Vestibular rehabilitation exercise in people with Hearing Loss and Gait, Unsteady, run by Western Norway University of Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short physical performance battery (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.