Outcome Measures for Pediatric Wheelchairs in Low-resourc... | NCT01530425

Studies
Outcome Measures for Pediatric Wheelchairs in Low-resource Settings

NCT01530425

Sponsor

Bethany Relief and Rehabilitation International Inc.

Status

Terminated

Last Update Posted

Jul 19, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Shoulder Impingement
Pressure Ulcer

Interventions

Not provided

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sufficient info

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Feb 9, 2012

First Posted Date

Feb 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Name	Class
LeTourneau University	OTHER
Queen's University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Rispin	LeTourneau University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kenyan Primary School		Thika			Kenya

Condition Browse Module

MeSH Terms

ID	Term
D019534	Shoulder Impingement Syndrome
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070599	Shoulder Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided