HealthyNCT00400452
Manual Wheelchair Skills Training for Long-term-care Residents
A study testing wheelchair skills training in people with Healthy and Wheelchair Users, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
It is hypothesized that, compared to a control group, manual wheelchair users and their caregivers in the long-term-care setting who receive the wheelchair skills training program will improve their wheelchair skills to a statistically significant extent and will retain these improvements for at least one month. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Wheelchair Users
- What is being tested?
- wheelchair skills training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Jul 2009
- Phase
- Interventional
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- be seventeen (17) or older
- be a manual wheelchair user, living in a long-term-care facility;
- be expected to require the long-term use of a wheelchair (at least four [4] hours/week for at least eight [8] weeks), as reported by a clinical therapist;
- be competent to give informed consent (as indicated by a Mini Mental State Examination score of 20 or higher) or have a proxy with power of attorney willing to provide consent,
- have the verbal endorsement of the clinical therapist (if any) to participate;
- have the written permission of the attending physician to participate;
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- be willing to take part in the study, including signing the consent after carefully reading it.
- be seventeen (17) or older;
- provide at least part-time [at least one (1) hour/week] wheelchair-handling care for a wheelchair user in a long-term-care facility;
- be willing to take part in the study, including signing the consent form after carefully reading it.
Who cannot join
- have an unstable medical condition (e.g. angina, seizures), as determined by the attending physician, house staff or ERN;
- have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending physician, house staff or ERN.
- have an unstable medical condition (e.g. angina, seizures), as indicated by self-report;
- have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by self-report.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Camp Hill Veteran's Memorial Building, Capital Health
Halifax, Nova Scotia, B3H 2E1
About this study
Official title: Manual Wheelchair Skills Training for Long-term-care Residents: A Pilot Randomized Controlled Trial of Efficacy
It is hypothesized that, compared to a control group, manual wheelchair users and their caregivers in the long-term-care setting who receive the wheelchair skills training program will improve their wheelchair skills to a statistically significant extent and will retain these improvements for at least one month.
- Conditions
- Healthy, Wheelchair Users
- Being tested
- wheelchair skills training
- Keywords
- wheelchair, skills, long-term-care, caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheelchair skills trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair Skills Test
Secondary outcomes (2)
demographics
Mini-Mental State Examination score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startMay 2007
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Investigators
- Cher Smith, Principal investigator, Capital Health, Department of Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400452
- Sponsor's protocol ID
- CDHA014
- Status last verified
- Jul 2009
- First submitted
- 15 Nov 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith C, Kirby RL. Manual wheelchair skills capacity and safety of residents of a long-term-care facility. Arch Phys Med Rehabil. 2011 Apr;92(4):663-9. doi: 10.1016/j.apmr.2010.11.024. Epub 2011 Mar 2.
PubMed 21367398
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Wheelchair Skills Training for Long-term-care Residents: A Pilot Randomized Controlled Trial of Efficacy
- ClinicalTrials.gov ID
- NCT00400452
- Acronym / sponsor ID
- CDHA014
- Conditions
- Healthy, Wheelchair Users
- Keywords
- wheelchair, skills, long-term-care, caregivers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Nov 2006 (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.
It is hypothesized that, compared to a control group, manual wheelchair users and their caregivers in the long-term-care setting who receive the wheelchair skills training program will improve their wheelchair skills to a statistically significant extent and will retain these improvements for at least one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- be seventeen (17) or older
- be a manual wheelchair user, living in a long-term-care facility;
- be expected to require the long-term use of a wheelchair (at least four [4] hours/week for at least eight [8] weeks), as reported by a clinical therapist;
- be competent to give informed consent (as indicated by a Mini Mental State Examination score of 20 or higher) or have a proxy with power of attorney willing to provide consent,
- have the verbal endorsement of the clinical therapist (if any) to participate;
Key exclusion criteria (4 listed)
- have an unstable medical condition (e.g. angina, seizures), as determined by the attending physician, house staff or ERN;
- have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending physician, house staff or ERN.
- have an unstable medical condition (e.g. angina, seizures), as indicated by self-report;
- have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by self-report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wheelchair skills training | Behavioural | – |
Primary outcome
Wheelchair Skills Test
2 secondary outcomes
demographics
Mini-Mental State Examination score
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Results publication: PubMed 21367398Smith C, Kirby RL. Manual wheelchair skills capacity and safety of residents of a long-term-care facility. Arch Phys Med Rehabil. 2011 Apr;92(4):663-9. doi: 10.1016/j.apmr.2010.11.024. Epub 2011 Mar 2.
- Related InfoLink provided by the sponsor.
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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.
Cher Smith principal investigator
Capital Health, Department of Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wheelchair skills training in people with Healthy and Wheelchair Users, run by Nova Scotia Health Authority at 1 site in Canada.
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 10 inclusion and 4 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 6 Jul 2011. 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 Canada. 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: poor enrollment). 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?
Wheelchair Skills Test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400452, which also lists 1 linked publication.
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 6 Jul 2011.