A Study of Why People With Early Memory Problems Fall or... | NCT00434889

Studies
A Study of Why People With Early Memory Problems Fall or Almost Fall

NCT00434889

Sponsor

University of Saskatchewan

Status

Unknown status

Last Update Posted

Jan 11, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Dementia
Falls
Near-Falls

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Dec 2009Estimated

First Submitted Date

Feb 13, 2007

First Submission Date that Met QC Criteria

Feb 13, 2007

First Posted Date

Feb 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2010

Last Update Posted Date

Jan 11, 2010Estimated

Name	Class
Saskatchewan Health Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia.

Detailed Description

The specific objectives of this six month study are to: characterize falls and near-falls in community dwelling older adults with early-stage dementia; determine which potentially modifiable physical fall risk factors contribute to falls and near-falls in older adults with early-stage dementia; examine the relationship between dementia sub-type, medical and neuropsychological factors, balance and gait, and falls and near-falls in community dwelling older adults with early-stage dementia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Memory problems
2		No memory problems

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males or females over the age of 50 with early-stage dementia as described by Global Deterioration Scale levels 2,3,4 or 5.

Exclusion Criteria:

subjects who have a medical condition that significantly predispose them to falls (Meneire's disease or Parkinson's disease)
subjects without a caregiver/spouse to assist with the completion of a Fall Diary
subjects unable to stand independently or safely walk a short distance either unaided or with the support of an assistive device
subjects unable to safely complete the balance and gait evaluations.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanina Dal Bello-Haas, Ph.D	Contact	306-966-6570		vanina.dalbello-haas@usask.ca

Overall Officials

Name	Affiliation	Role
Vanina Dal Bello-Haas, Ph.D	University of Saskatchewan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Physical Therapy, University of Saskatchewan	Recruiting	Saskatoon	Saskatchewan	S7N 0W3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided