Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly

Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly: What is the Impact of Benign Paroxysmal Positional Vertigo (BPPV) and Treatment Effectiveness?

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.

Study Overview

• Status: Unknown
• Conditions: Institutional Frail Elderly
• Intervention / Treatment: Other: evaluation and treatment maneuver for BPPV

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Hasselt University
    • Contact: Joke Spildooren, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

institutionalized frail elderly

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	baseline
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	month 1
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	month 2
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	month 3
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	month 4
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	month 5
outcome of the vestibular bedside testing	outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)	month 6
static and dynamic balance using the Mobility lab (APDM-sensors)	static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG	baseline
static and dynamic balance using the Mobility lab (APDM-sensors)	static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG	month 3
Four Test Balance Scale (4TBS)		baseline
Four Test Balance Scale (4TBS)		month 1
Four Test Balance Scale (4TBS)		month 2
Four Test Balance Scale (4TBS)		month 3
Four Test Balance Scale (4TBS)		month 4
Four Test Balance Scale (4TBS)		month 5
Four Test Balance Scale (4TBS)		month 6
Functional Ambulation categories (FAC)		baseline
Functional Ambulation categories (FAC)		month 1
Functional Ambulation categories (FAC)		month 2
Functional Ambulation categories (FAC)		month 3
Functional Ambulation categories (FAC)		month 4
Functional Ambulation categories (FAC)		month 5
Functional Ambulation categories (FAC)		month 6
Dizziness Handicap Inventory (DHI)		baseline
Dizziness Handicap Inventory (DHI)		month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall incidents		baseline
Fall incidents		month 1
Fall incidents		month 2
Fall incidents		month 3
Fall incidents		month 4
Fall incidents		month 5
Fall incidents		month 6
fear of falling	fear of falling: Falls Efficacy Scale	baseline
fear of falling	fear of falling: Falls Efficacy Scale	month 3
depression	depression: Geriatric depression scale	baseline
depression	depression: Geriatric depression scale	month 3
ambulatory activity level	ambulatory activity level: the StepWatch Activity Monitor (SAM)	baseline
ambulatory activity level	ambulatory activity level: the StepWatch Activity Monitor (SAM)	month 3

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Joke spildooren, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BPPV-ELDERLY-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED