Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001259134
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
11/09/2019
Date last updated
11/09/2019
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Peer-Led Wheelchair Skills Groups for Children.
Scientific title
Evaluation of the influence of peer-led wheelchair skills groups on satisfaction with participation and mobility skills among children.
Secondary ID [1] 299090 0
Nil known
Universal Trial Number (UTN)
U1111-1230-2708
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wheelchair efficacy 314129 0
Rehabilitation 314130 0
Children with physical disability 314131 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312504 312504 0 0
Other physical medicine / rehabilitation
Musculoskeletal 312662 312662 0 0
Other muscular and skeletal disorders
Neurological 312663 312663 0 0
Other neurological disorders
Injuries and Accidents 312664 312664 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children who use a manual or power wheelchair for mobility will attend 2 x 2hr wheelchair skills groups facilitated by peer mentors (adult wheelchair users) at a ratio of 1 mentor: 3 children. The sessions are once a week for 2 weeks and the same group of children will participate in both sessions. The skills group programme follows a set structure and timetable and is the same programme that has been used by Seating To Go for the delivery of peer mentored group wheelchair skills training since 2013. Activities and skills being taught have been modelled on the Wheelchair Skills Programme developed by Dalhousie University, Canada. (Source: https://wheelchairskillsprogram.ca/en/ ). There is capacity for the mentors to teach different techniques to achieve the same task dependent on the participant's level of ability. The majority of group activities are of light intensity (9-12 on the BORG scale) with ascending ramps being somewhat hard (13-14 on the BORG scale). Session attendance lists are used to monitor adherence to the intervention.
Participants in the study (the groups are not limited to study participants) will be asked to bring a support person who can physically assist them during the groups as a spotter. This could be a parent, carer, therapist or teacher aide. The spotter will be sent a video prior to the groups that shows safe spotting techniques during various group activities, and wheelchair skills. The video has been developed by Seating To Go therapists and peer mentors and is sent to all participants of skills groups facilitated by Seating To Go, not just the study participants. It is not publicly available. During the groups, the peer mentors will demonstrate skills (e.g. ascending and descending a ramp), lead participants through practice of skills, and provide coaching. A Wheelchair and Seating Therapist (Occupational Therapist or Physiotherapist with the New Zealand Ministry of Health Level 2 Wheeled Mobility and Postural Management credential) and wheelchair technician will assist with time monitoring of the session, assist spotters, and undertake adjustments to participants' wheelchair configuration that may assist with skill development (e.g. adjusting tyre inflation pressure in rear wheels, changing the rear axle position).
Intervention code [1] 315359 0
Rehabilitation
Intervention code [2] 315500 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321139 0
Change in satisfaction with participation in desired activities whilst using a wheelchair. Measured by the Wheelchair Outcome Measure for Young People (WhOM-YP) Version Jan 15, 2018 pre and post intervention.
Timepoint [1] 321139 0
Up to 21 days following the second group session at a time that is mutually agreed with the participant and their parent/guardian.
Secondary outcome [1] 374206 0
Change in wheelchair skills as shown on the Wheelchair Skills Test (WST) version 5.0. Measured pre and post intervention.
Timepoint [1] 374206 0
Up to 21 days following the second group session at a time that is mutually agreed with the participant and their parent/guardian
Secondary outcome [2] 374207 0
Change in parent/guardian perception of how well they believe their child can perform wheelchair skills. Measured by the Wheelchair Skills Test Questionnaire (WST-Q) version 5.0, pre and post intervention.
Timepoint [2] 374207 0
Up to 21 days after the second group session at a time that is mutually agreed with the parent/guardian.
Secondary outcome [3] 374208 0
Change in confidence of the participants as measured by the Wheelchair Use Confidence Scale for Children, commonly called WheelCon, pre and post intervention
Timepoint [3] 374208 0
Up to 21 days after the second group session at a time that is mutually agreed with the participant and parent/guardian.

Eligibility
Key inclusion criteria
Over 4- under 16 years old
Have their own manual or power wheelchair
Can self-propel a manual wheelchair or drive a power wheelchair without assistance at least 10m
Able to follow a two-step command in English

Parents/guardians of children over 4 and under 16 years of age who have their own manual or power wheelchair, can self propel or drive a power wheelchair without assistance at least 10m , and are able to follow a two-step command in English.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anticipated health condition or procedure that contraindicates training e.g. surgery
Has a degenerative condition that is expected to progress quickly
Are attending, or planning, to attend alternative training.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are aiming for a sample size of up to 40 children. Descriptive statistics (means, medians, standard deviations, and percentages) will be used to describe the sample. Assumptions for parametric statistics will be done (ie. paired t-test or Wilcoxin signed rank test) to evaluate the difference in the baseline and follow-up scores for the WhOM, WST, WST-Q and WheelCon measures. Statistical significance will be set as alpha=0.05 and 95% confidence intervals will be derived. Intention-to-treat analysis will be performed. We will not correct for multiple testing bias but will note this as a limitation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 21809 0
New Zealand
State/province [1] 21809 0
Waikato, Bay of Plenty, Lakes and Auckland

Funding & Sponsors
Funding source category [1] 303626 0
Other
Name [1] 303626 0
Seating To Go
Country [1] 303626 0
New Zealand
Primary sponsor type
Other
Name
Seating To Go
Address
21 West St
PO Box 5725
Frankton, Hamilton.3204.
Country
New Zealand
Secondary sponsor category [1] 303741 0
None
Name [1] 303741 0
Address [1] 303741 0
Country [1] 303741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304152 0
Northern B Health & Disability Ethics Committee
Ethics committee address [1] 304152 0
Ethics committee country [1] 304152 0
New Zealand
Date submitted for ethics approval [1] 304152 0
14/03/2019
Approval date [1] 304152 0
17/05/2019
Ethics approval number [1] 304152 0
19/NTB/41

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95978 0
Mrs Debbie Wilson
Address 95978 0
Seating To Go
21 West St
PO Box 5725
Hamilton. 3204
Country 95978 0
New Zealand
Phone 95978 0
+64 272772571
Fax 95978 0
Email 95978 0
[email protected]
Contact person for public queries
Name 95979 0
Debbie Wilson
Address 95979 0
Seating To Go
21 West St
PO Box 5725
Hamilton. 3204
Country 95979 0
New Zealand
Phone 95979 0
+64 272772571
Fax 95979 0
Email 95979 0
[email protected]
Contact person for scientific queries
Name 95980 0
Krista Best
Address 95980 0
Postdoctoral Fellow
Universite Laval
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
525 Boulevard Wilfred-Hamil
Quebec
Country 95980 0
Canada
Phone 95980 0
+17788468390
Fax 95980 0
Email 95980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are working with a vulnerable population, ie children and young people with disabilities and are unable to provide consent. Methodological reasons include that this is a preliminary trial with a single intervention arm with no control therefore will only provide pilot data to inform future definitive studies.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4332Study protocol  [email protected]
4333Informed consent form  [email protected]
4334Ethical approval  [email protected]
4335Analytic code  [email protected]
4336Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.