NCT00400452

Brief Summary

It is hypothesized that, compared to a control group, manual wheelchair users and their caregivers in the long-term-care setting who receive the wheelchair skills training program will improve their wheelchair skills to a statistically significant extent and will retain these improvements for at least one month.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 6, 2011

Status Verified

July 1, 2009

Enrollment Period

2.2 years

First QC Date

November 15, 2006

Last Update Submit

July 4, 2011

Conditions

Keywords

wheelchairskillslong-term-carecaregivers

Outcome Measures

Primary Outcomes (1)

  • Wheelchair Skills Test

Secondary Outcomes (2)

  • demographics

  • Mini-Mental State Examination score

Interventions

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • be seventeen (17) or older
  • be a manual wheelchair user, living in a long-term-care facility;
  • be expected to require the long-term use of a wheelchair (at least four \[4\] hours/week for at least eight \[8\] weeks), as reported by a clinical therapist;
  • be competent to give informed consent (as indicated by a Mini Mental State Examination score of 20 or higher) or have a proxy with power of attorney willing to provide consent,
  • have the verbal endorsement of the clinical therapist (if any) to participate;
  • have the written permission of the attending physician to participate;
  • be willing to take part in the study, including signing the consent after carefully reading it.

You may not qualify if:

  • have an unstable medical condition (e.g. angina, seizures), as determined by the attending physician, house staff or ERN;
  • have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending physician, house staff or ERN.
  • be seventeen (17) or older;
  • provide at least part-time \[at least one (1) hour/week\] wheelchair-handling care for a wheelchair user in a long-term-care facility;
  • be willing to take part in the study, including signing the consent form after carefully reading it.
  • have an unstable medical condition (e.g. angina, seizures), as indicated by self-report;
  • have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by self-report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camp Hill Veteran's Memorial Building, Capital Health

Halifax, Nova Scotia, B3H 2E1, Canada

Location

Related Publications (1)

  • Smith C, Kirby RL. Manual wheelchair skills capacity and safety of residents of a long-term-care facility. Arch Phys Med Rehabil. 2011 Apr;92(4):663-9. doi: 10.1016/j.apmr.2010.11.024. Epub 2011 Mar 2.

Related Links

Study Officials

  • Cher Smith

    Capital Health, Department of Occupational Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

May 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 6, 2011

Record last verified: 2009-07

Locations