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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01530425
Other study ID # BKK-WRWC
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 2011
Est. completion date December 2014

Study information

Verified date February 2015
Source Bethany Relief and Rehabilitation International Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Kenya Kenyan Primary School Thika

Sponsors (3)

Lead Sponsor Collaborator
Bethany Relief and Rehabilitation International Inc. LeTourneau University, Queen's University

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary physiologic costs (FEW) energy costs will be measured, feedback will be obtained from children (VAS) within 1 year of wheelchair acquisition for each phase
Secondary medical complications direct assessment by physician for Musculoskeletal and Skin complications within 24 months after wheelchair distribution for each phase
Secondary participation using decriptive data to describe effect of wheelchair use on participation in school and play within 24 months after wheelchair distribution for each phase
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