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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pressure Ulcer; Shoulder Impingement

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Kenya
  • Thika, Kenya
    • Kenyan Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
medical complications	direct assessment by physician for Musculoskeletal and Skin complications	within 24 months after wheelchair distribution for each phase
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

Collaborators and Investigators

• Sponsor: Bethany Relief and Rehabilitation International Inc.
• Collaborators: Queen's University; LeTourneau University
• Investigators: Principal Investigator: Karen Rispin, LeTourneau University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimate): February 10, 2012

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: low-income; pediatric wheelchairs; comparisons
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Skin Ulcer; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome; Pressure Ulcer
• Other Study ID Numbers: BKK-WRWC