Outcome Measures for Pediatric Wheelchairs in Low-resource Settings

Pressure Ulcer Clinical Trial

— Wheels  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01530425
• Other study ID #: BKK-WRWC
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Pressure Ulcer
• Shoulder Impingement

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