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

Primary Purpose

Hearing Loss, Gait, Unsteady, Balance; Distorted

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality exercise
Vestibular rehabilitation exercise
Control
Sponsored by
Western Norway University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hearing threshold above 30 dB

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Virtual reality exercise

    Vestibular rehabilitation exercise

    Control

    Arm Description

    20 participants will be randomised to this arm

    20 participants will be randomised to this arm

    20 participants will be randomised to this arm

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Standing balance - posturography
    Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface
    Walking balance
    Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
    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

    Full Information

    First Posted
    December 22, 2019
    Last Updated
    February 24, 2020
    Sponsor
    Western Norway University of Applied Sciences
    Collaborators
    Haukeland University Hospital, University of Dublin, Trinity College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04283279
    Brief Title
    Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
    Official Title
    Balance and Mobility in Older Adults With Hearing Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    September 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Norway University of Applied Sciences
    Collaborators
    Haukeland University Hospital, University of Dublin, Trinity College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Gait, Unsteady, Balance; Distorted, Old Age; Debility

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual reality exercise
    Arm Type
    Experimental
    Arm Description
    20 participants will be randomised to this arm
    Arm Title
    Vestibular rehabilitation exercise
    Arm Type
    Experimental
    Arm Description
    20 participants will be randomised to this arm
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    20 participants will be randomised to this arm
    Intervention Type
    Other
    Intervention Name(s)
    Virtual reality exercise
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Vestibular rehabilitation exercise
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
    Primary Outcome Measure Information:
    Title
    Short physical performance battery
    Description
    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 Outcome Measure Information:
    Title
    Standing balance - posturography
    Description
    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
    Title
    Walking balance
    Description
    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
    Title
    The World Health Organisation Disability Assessment Schedule (WHODAS)
    Description
    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 Pre-specified Outcome Measures:
    Title
    Activity monitoring
    Description
    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)
    Title
    Dizziness Handicap Inventory
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hearing threshold above 30 dB Exclusion Criteria: Inability to give informed consent, Inability to speak Scandinavian languages or English Diseases with severe motor impairments (such as mb Parkinsons)

    12. IPD Sharing Statement

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

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