Shoulder ImpingementWheelsNCT01530425
Outcome Measures for Pediatric Wheelchairs in Low-resource Settings
An observational study of Shoulder Impingement and Pressure Ulcer, run by Bethany Relief and Rehabilitation International Inc. at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement, Pressure Ulcer
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- Mar 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Children who would benefit from available study wheelchairs who are able to provide feedback
Who cannot join
- Children who are not able to provide feedback on the study wheelchairs
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Shoulder Impingement, Pressure Ulcer
- Keywords
- pediatric wheelchairs, low-income, comparisons
- Medical subject headings
- Shoulder Impingement Syndrome, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
physiologic costs (FEW)
energy costs will be measured, feedback will be obtained from children (VAS)
Measured: within 1 year of wheelchair acquisition for each phase
Secondary outcomes (2)
medical complications
direct assessment by physician for Musculoskeletal and Skin complications
Measured: 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
Measured: within 24 months after wheelchair distribution for each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: sufficient info
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bethany Relief and Rehabilitation International Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- LeTourneau University, Queen's University
- Responsible party
- Sponsor
- Investigators
- Karen Rispin, Principal investigator, LeTourneau University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530425
- Sponsor's protocol ID
- BKK-WRWC
- Acronym
- Wheels
- Status last verified
- Feb 2015
- First submitted
- 21 Jun 2011
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01530425
- Acronym / sponsor ID
- Wheels / BKK-WRWC
- Conditions
- Shoulder Impingement, Pressure Ulcer
- Keywords
- pediatric wheelchairs, low-income, comparisons
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sufficient info
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bethany Relief and Rehabilitation International Inc.University, hospital or other
- Collaborators
- LeTourneau University, Queen's University
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children who would benefit from available study wheelchairs who are able to provide feedback
Key exclusion criteria (1 listed)
- Children who are not able to provide feedback on the study wheelchairs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
physiologic costs (FEW)
Time frame: within 1 year of wheelchair acquisition for each phase
energy costs will be measured, feedback will be obtained from children (VAS)
2 secondary outcomes
medical complications
Time frame: within 24 months after wheelchair distribution for each phase
participation
Time frame: within 24 months after wheelchair distribution for each phase
Results and safety
The study was stopped early (reason given: sufficient info). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
Related trials for Shoulder Impingement
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TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
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Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
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"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Rispin principal investigator
LeTourneau University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Impingement and Pressure Ulcer, run by Bethany Relief and Rehabilitation International Inc. at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sufficient info). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiologic costs (FEW) (time frame: within 1 year of wheelchair acquisition for each phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.