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Outcome Measures for Pediatric Wheelchairs in Low-resource Settings (Wheels)

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ClinicalTrials.gov Identifier: NCT01530425
Recruitment Status : Unknown
Verified February 2012 by Bethany Relief and Rehabilitation International Inc..
Recruitment status was:  Recruiting
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Two wheelchair types available for children in Kenya are compared for energy costs, utility, and complications. This study will arrive at a protocol for comparing wheelchairs in low-income settings, and in the process, provide wheelchair makers and providers with specific feedback. It also serves as a means to increase the skills of local health professionals working with the children in this study, while providing them with appropriate wheelchairs to use.

Condition or disease
Shoulder Impingement Pressure Ulcer

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Development of a Suite of Outcomes Measures Suitable for Use in Low-resource Settings to Compare Pediatric Wheelchairs Within the Framework of the International Classification of Function, Disability and Health
Study Start Date : March 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2014
Groups and Cohorts

Group/Cohort
Phase 1 comparison
Regency Wheelchairs vs. APDK 12-inch wide wheelchairs
Healthy volunteers
Children pairs in US, 1 high school student pushing 1 elementary student, to test wheelchairs used in study


Outcome Measures

Primary Outcome Measures :
  1. physiologic costs (FEW) [ Time Frame: within 1 year of wheelchair acquisition for each phase ]
    energy costs will be measured, feedback will be obtained from children (VAS)


Secondary Outcome Measures :
  1. medical complications [ Time Frame: within 24 months after wheelchair distribution for each phase ]
    direct assessment by physician for Musculoskeletal and Skin complications

  2. participation [ Time Frame: within 24 months after wheelchair distribution for each phase ]
    using decriptive data to describe effect of wheelchair use on participation in school and play


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with disabilities in a primary school in Kenya who would benefit from available study wheelchairs, and who can provide feedback. Assent provided with parental consent.
Criteria

Inclusion Criteria:

  • Children who would benefit from available study wheelchairs who are able to provide feedback

Exclusion Criteria:

  • Children who are not able to provide feedback on the study wheelchairs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530425


Contacts
Contact: Joy Wee, MD 613-544-2143 weej@queensu.ca

Locations
Kenya
Kenyan Primary School Recruiting
Thika, Kenya
Sponsors and Collaborators
Bethany Relief and Rehabilitation International Inc.
LeTourneau University
Queen's University
Investigators
Principal Investigator: Karen Rispin LeTourneau University
More Information

Responsible Party: Bethany Relief and Rehabilitation International Inc.
ClinicalTrials.gov Identifier: NCT01530425     History of Changes
Other Study ID Numbers: BKK-WRWC
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Bethany Relief and Rehabilitation International Inc.:
pediatric wheelchairs
low-income
comparisons

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases