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Register:	ClinicalTrials.gov
Last refreshed on:	26 September 2016
Main ID:	NCT02905292
Date of registration:	14/09/2016
Prospective Registration:	No
Primary sponsor:	Hasselt University
Public title:	Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly
Scientific title:	Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly: What is the Impact of Benign Paroxysmal Positional Vertigo (BPPV) and Treatment Effectiveness?
Date of first enrolment:	September 2016
Target sample size:	400
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02905292
Study type:	Observational
Study design:	Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Belgium

Contacts

Name:	Joke Spildooren, dr.
Address:
Telephone:
Email:	joke.spildooren@uhasselt.be
Affiliation:

Name:	Joke Spildooren, dr.
Address:
Telephone:
Email:
Affiliation:

Name:	Joke spildooren, dr.
Address:
Telephone:
Email:
Affiliation:	Hasselt University

Key inclusion & exclusion 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

Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Institutional Frail Elderly

Intervention(s)

Other: evaluation and treatment maneuver for BPPV

Primary Outcome(s)

Four Test Balance Scale (4TBS) [Time Frame: month 5]

Four Test Balance Scale (4TBS) [Time Frame: month 1]

Functional Ambulation categories (FAC) [Time Frame: month 2]

Dizziness Handicap Inventory (DHI) [Time Frame: baseline]

Functional Ambulation categories (FAC) [Time Frame: baseline]

outcome of the vestibular bedside testing [Time Frame: month 2]

static and dynamic balance using the Mobility lab (APDM-sensors) [Time Frame: month 3]

outcome of the vestibular bedside testing [Time Frame: baseline]

Functional Ambulation categories (FAC) [Time Frame: month 1]

outcome of the vestibular bedside testing [Time Frame: month 3]

Four Test Balance Scale (4TBS) [Time Frame: baseline]

Functional Ambulation categories (FAC) [Time Frame: month 5]

outcome of the vestibular bedside testing [Time Frame: month 1]

Four Test Balance Scale (4TBS) [Time Frame: month 2]

Four Test Balance Scale (4TBS) [Time Frame: month 3]

Functional Ambulation categories (FAC) [Time Frame: month 6]

outcome of the vestibular bedside testing [Time Frame: month 4]

outcome of the vestibular bedside testing [Time Frame: month 5]

outcome of the vestibular bedside testing [Time Frame: month 6]

Dizziness Handicap Inventory (DHI) [Time Frame: month 3]

Four Test Balance Scale (4TBS) [Time Frame: month 4]

Four Test Balance Scale (4TBS) [Time Frame: month 6]

Functional Ambulation categories (FAC) [Time Frame: month 3]

Functional Ambulation categories (FAC) [Time Frame: month 4]

static and dynamic balance using the Mobility lab (APDM-sensors) [Time Frame: baseline]

Secondary Outcome(s)

Fall incidents [Time Frame: month 6]

ambulatory activity level [Time Frame: baseline]

Fall incidents [Time Frame: baseline]

ambulatory activity level [Time Frame: month 3]

Fall incidents [Time Frame: month 3]

Fall incidents [Time Frame: month 2]

fear of falling [Time Frame: baseline]

depression [Time Frame: baseline]

Fall incidents [Time Frame: month 4]

Fall incidents [Time Frame: month 5]

Fall incidents [Time Frame: month 1]

fear of falling [Time Frame: month 3]

depression [Time Frame: month 3]

Secondary ID(s)

BPPV-ELDERLY-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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