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

24. februar 2020 oppdatert av: Bård Bogen, Western Norway University of Applied Sciences

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

70 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Virtual reality exercise
20 participants will be randomised to this arm
Annen: Virtual 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.
Eksperimentell: Vestibular rehabilitation exercise
20 participants will be randomised to this arm
Annen: Vestibular 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.
Annen: Control
20 participants will be randomised to this arm
Annen: Control
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Short physical performance battery
Tidsramme: 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.
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Standing balance - posturography
Tidsramme: 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
Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface
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
Tidsramme: 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
Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
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)
Tidsramme: 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
Questionnaire that registers disability across several domains. Possible score range is 0-144, where lower values indicate less disability
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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Activity monitoring
Tidsramme: Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
Participants will wear sensors over 4 days, registering activity in their own environments
Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
Dizziness Handicap Inventory
Tidsramme: Measured at baseline/before intervention and after intervention (6 weeks after baseline)
25 item-questionnaire that registers limitations due to dizziness. Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.
Measured at baseline/before intervention and after intervention (6 weeks after baseline)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Western Norway University of Applied Sciences

Samarbeidspartnere

Haukeland University Hospital
University of Dublin, Trinity College

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. mai 2020

Primær fullføring (Forventet)

31. desember 2021

Studiet fullført (Forventet)

1. september 2022

Datoer for studieregistrering

Først innsendt

22. desember 2019

Først innsendt som oppfylte QC-kriteriene

24. februar 2020

Først lagt ut (Faktiske)

25. februar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2019/FO243016

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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