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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01530425
Recruitment Status : Terminated (sufficient info)
First Posted : February 10, 2012
Last Update Posted : July 19, 2018
LeTourneau University
Queen's University
Information provided by (Responsible Party):
Bethany Relief and Rehabilitation International Inc.

Brief Summary:
Two wheelchair types available for children in Kenya are assessed for energy costs, utility, and complications. This study will arrive at a protocol for assessing 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

Detailed Description:
In each of 2011, 2012, and 2013, two different low cost wheelchairs were assessed. User feedback, health professional feedback, and objective measures were employed for these assessments in the real world setting. Participants for each phase were recruited from a Kenyan Primary or Secondary Schools for children with disability.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
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
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Phase 1 assessments
Regency Wheelchairs and APDK 12-inch wide wheelchairs
Phase 2 assessments
Hope Haven and APDK 14-16 inch wide wheelchairs
Phase 3 assessments
Motivation and Whirlwind wheelchairs

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

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.

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

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 identifier (NCT number): NCT01530425

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Kenyan Primary School
Thika, Kenya
Sponsors and Collaborators
Bethany Relief and Rehabilitation International Inc.
LeTourneau University
Queen's University
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Principal Investigator: Karen Rispin LeTourneau University
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Responsible Party: Bethany Relief and Rehabilitation International Inc. Identifier: NCT01530425    
Other Study ID Numbers: BKK-WRWC
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: February 2015
Keywords provided by Bethany Relief and Rehabilitation International Inc.:
pediatric wheelchairs
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Pressure Ulcer
Skin Ulcer
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries