Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Bethany Relief and Rehabilitation International Inc..
Recruitment status was  Recruiting
LeTourneau University
Queen's University
Information provided by (Responsible Party):
Bethany Relief and Rehabilitation International Inc. Identifier:
First received: June 21, 2011
Last updated: February 9, 2012
Last verified: February 2012

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.

Shoulder Impingement
Pressure Ulcer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bethany Relief and Rehabilitation International Inc.:

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

Secondary Outcome Measures:
  • medical complications [ Time Frame: within 24 months after wheelchair distribution for each phase ] [ Designated as safety issue: Yes ]
    direct assessment by physician for Musculoskeletal and Skin complications

  • participation [ Time Frame: within 24 months after wheelchair distribution for each phase ] [ Designated as safety issue: No ]
    using decriptive data to describe effect of wheelchair use on participation in school and play

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01530425

Contact: Joy Wee, MD 613-544-2143

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

No publications provided

Responsible Party: Bethany Relief and Rehabilitation International Inc. Identifier: NCT01530425     History of Changes
Other Study ID Numbers: BKK-WRWC
Study First Received: June 21, 2011
Last Updated: February 9, 2012
Health Authority: Kenya: Ethical Review Committee

Keywords provided by Bethany Relief and Rehabilitation International Inc.:
pediatric wheelchairs

Additional relevant MeSH terms:
Pressure Ulcer
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Skin Diseases
Skin Ulcer processed this record on February 25, 2015