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TerminatedNCT01530425WheelsUpdated Jul 19, 2018

Outcome Measures for Pediatric Wheelchairs in Low-resource Settings

An observational study in Shoulder Impingement and Pressure Ulcer, sponsored by Bethany Relief and Rehabilitation International Inc.. Terminated at 1 site in Kenya. Open to participants aged 6 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Bethany Relief and Rehabilitation International Inc. · Observational

Why this study was terminated
sufficient info
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
6 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Impingement
  • Pressure Ulcer

Keywords

  • pediatric wheelchairs
  • low-income
  • comparisons
03

In context

Shoulder Impingement Syndrome

304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 39 observational studies indexed under Shoulder Impingement Syndrome.

Browse Shoulder Impingement Syndrome studies →

Lead sponsor

This is the only study on the registry with Bethany Relief and Rehabilitation International Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 25 Years
Sexes eligible
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

Exclusion Criteria:

  • Children who are not able to provide feedback on the study wheelchairs
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. physiologic costs (FEW)

    energy costs will be measured, feedback will be obtained from children (VAS)

    Time frame: within 1 year of wheelchair acquisition for each phase

Secondary outcomes

  1. medical complications

    direct assessment by physician for Musculoskeletal and Skin complications

    Time frame: within 24 months after wheelchair distribution for each phase

  2. participation

    using decriptive data to describe effect of wheelchair use on participation in school and play

    Time frame: within 24 months after wheelchair distribution for each phase

07

Study locations

1 site
  • Kenyan Primary School
    Thika, Kenya
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01530425
Lead sponsor
Bethany Relief and Rehabilitation International Inc.
Collaborators
LeTourneau University, Queen's University
Responsible party
Sponsor
First posted
Feb 10, 2012
Start date
Mar 2011
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jul 19, 2018

Study contacts

Karen Rispin
principal investigator · LeTourneau University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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