Caregiver-aided Powered Wheelchair Skills | NCT02972307

Studies
Caregiver-aided Powered Wheelchair Skills

NCT02972307

Sponsor

Nova Scotia Health Authority

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Caregivers

Interventions

wheelchair skills

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 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Feb 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Nov 18, 2016

First Submission Date that Met QC Criteria

Nov 21, 2016

First Posted Date

Nov 23, 2016Estimated

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 10, 2018

Last Update Posted Date

Jan 12, 2018Actual

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

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

There has been only minimal research on wheelchair skills by the caregivers of manual or powered wheelchair. There are no published data on the extent to which caregivers can enhance the mobility of powered wheelchair users. The primary objective of this study is to test the hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance of the powered wheelchair users to whom they provide assistance. Our secondary objective is to add to the literature on the measurement properties of the wheelchair skills test (questionnaire and capability version) for powered wheelchair users and their caregivers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

152Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
caregiver		dyad of caregiver and the wheelchair user to whom they provide care	Other: wheelchair skills

Interventions

Name	Type	Description	Arm Group Labels	Other Names
wheelchair skills	Other	the extent to which caregivers enhance the wheelchair skills of powered wheelchair users	caregiver

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wheelchair Skills Test (WST)	Objective (WST) and Questionnaire (WST-Q) versions	one day

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire	Qualitative open ended questions on wheelchair skills	one day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years of age
able to communicate in English and/or French (depending upon the site)
live within 50 km of the research centre
be willing to participate (as evidenced by completion of the assessment)
be able to set a scheduled time for the study visit when both the caregiver and wheelchair user will be present and provide informed consent

Caregivers:

must be an unpaid caregiver (e.g. a family member or friend)
spend an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility.

Wheelchair user:

must have his/her own powered wheelchair
use the powered wheelchair for at least 6 hours per week
have a caregiver who spends an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility.

Exclusion Criteria:

have unstable medical conditions (e.g. angina, seizures) that might make the use of a powered wheelchair dangerous
emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

dyads of caregivers and the wheelchair users to whom they provide care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lee Kirby, MD, FRCPC	Dalhousie University, Nova Scotia Health Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Scotia Rehabilitation Centre		Halifax	Nova Scotia	B3H 4K4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29305847	Derived	Kirby RL, Rushton PW, Routhier F, Demers L, Titus L, Miller-Polgar J, Smith C, McAllister M, Theriault C, Matheson K, Parker K, Sawatzky B, Labbe D, Miller WC. Extent to Which Caregivers Enhance the Wheelchair Skills Capacity and Confidence of Power Wheelchair Users: A Cross-Sectional Study. Arch Phys Med Rehabil. 2018 Jul;99(7):1295-1302.e9. doi: 10.1016/j.apmr.2017.11.014. Epub 2018 Jan 3.