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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00400452
Other study ID # CDHA014
Secondary ID
Status Terminated
Phase N/A
First received November 15, 2006
Last updated July 4, 2011
Start date May 2007
Est. completion date July 2009

Study information

Verified date July 2009
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 17 Years and older
Eligibility Inclusion Criteria (wheelchair user):

- 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.

Exclusion Criteria (wheelchair user):

- 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.

Inclusion Criteria (caregiver):

- 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.

Exclusion Criteria (caregiver):

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
wheelchair skills training


Locations

Country Name City State
Canada Camp Hill Veteran's Memorial Building, Capital Health Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Wheelchair Skills Test No
Secondary demographics No
Secondary Mini-Mental State Examination score No
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