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Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly

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ClinicalTrials.gov Identifier: NCT02905292
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
JSpildooren, Hasselt University

Brief Summary:
The overall objective of the research is to identify the prevalence and incidence of BPPV and the impact on balance problems, fall risk and inactivity in frail elderly. The investigators will demonstrate the importance of early diagnosis and treatment in this patient group.

Condition or disease Intervention/treatment
Institutional Frail Elderly Other: evaluation and treatment maneuver for BPPV

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Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Prospective
Official Title: Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly: What is the Impact of Benign Paroxysmal Positional Vertigo (BPPV) and Treatment Effectiveness?
Study Start Date : September 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. outcome of the vestibular bedside testing [ Time Frame: baseline ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  2. outcome of the vestibular bedside testing [ Time Frame: month 1 ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  3. outcome of the vestibular bedside testing [ Time Frame: month 2 ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  4. outcome of the vestibular bedside testing [ Time Frame: month 3 ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  5. outcome of the vestibular bedside testing [ Time Frame: month 4 ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  6. outcome of the vestibular bedside testing [ Time Frame: month 5 ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  7. outcome of the vestibular bedside testing [ Time Frame: month 6 ]
    outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)

  8. static and dynamic balance using the Mobility lab (APDM-sensors) [ Time Frame: baseline ]
    static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG

  9. static and dynamic balance using the Mobility lab (APDM-sensors) [ Time Frame: month 3 ]
    static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG

  10. Four Test Balance Scale (4TBS) [ Time Frame: baseline ]
  11. Four Test Balance Scale (4TBS) [ Time Frame: month 1 ]
  12. Four Test Balance Scale (4TBS) [ Time Frame: month 2 ]
  13. Four Test Balance Scale (4TBS) [ Time Frame: month 3 ]
  14. Four Test Balance Scale (4TBS) [ Time Frame: month 4 ]
  15. Four Test Balance Scale (4TBS) [ Time Frame: month 5 ]
  16. Four Test Balance Scale (4TBS) [ Time Frame: month 6 ]
  17. Functional Ambulation categories (FAC) [ Time Frame: baseline ]
  18. Functional Ambulation categories (FAC) [ Time Frame: month 1 ]
  19. Functional Ambulation categories (FAC) [ Time Frame: month 2 ]
  20. Functional Ambulation categories (FAC) [ Time Frame: month 3 ]
  21. Functional Ambulation categories (FAC) [ Time Frame: month 4 ]
  22. Functional Ambulation categories (FAC) [ Time Frame: month 5 ]
  23. Functional Ambulation categories (FAC) [ Time Frame: month 6 ]
  24. Dizziness Handicap Inventory (DHI) [ Time Frame: baseline ]
  25. Dizziness Handicap Inventory (DHI) [ Time Frame: month 3 ]

Secondary Outcome Measures :
  1. Fall incidents [ Time Frame: baseline ]
  2. Fall incidents [ Time Frame: month 1 ]
  3. Fall incidents [ Time Frame: month 2 ]
  4. Fall incidents [ Time Frame: month 3 ]
  5. Fall incidents [ Time Frame: month 4 ]
  6. Fall incidents [ Time Frame: month 5 ]
  7. Fall incidents [ Time Frame: month 6 ]
  8. fear of falling [ Time Frame: baseline ]
    fear of falling: Falls Efficacy Scale

  9. fear of falling [ Time Frame: month 3 ]
    fear of falling: Falls Efficacy Scale

  10. depression [ Time Frame: baseline ]
    depression: Geriatric depression scale

  11. depression [ Time Frame: month 3 ]
    depression: Geriatric depression scale

  12. ambulatory activity level [ Time Frame: baseline ]
    ambulatory activity level: the StepWatch Activity Monitor (SAM)

  13. ambulatory activity level [ Time Frame: month 3 ]
    ambulatory activity level: the StepWatch Activity Monitor (SAM)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
institutionalized frail elderly
Criteria

Inclusion Criteria:

  • Institutionalized in a nursing home for at least 3 months
  • Able to understand and follow simple instructions
  • Able to stand independently for 30 seconds
  • Willing to participate in the study

Exclusion Criteria:

  • diagnosis of progressive neurological diseases (such as Amyotrophic Lateral Sclerosis) resulting in a fast decline within 3 months
  • Rehabilitating for a neurological or orthopaedic incident such as knee prosthesis, stroke,… )
  • Contra-indication for Hallpike and Epley maneuver

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905292


Contacts
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Contact: Joke Spildooren, dr. joke.spildooren@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Hasselt, Belgium, 3500
Contact: Joke Spildooren, dr.         
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Joke spildooren, dr. Hasselt University

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Responsible Party: JSpildooren, dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02905292     History of Changes
Other Study ID Numbers: BPPV-ELDERLY-001
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided