ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Rehabilitation

Children with physical disability

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

Other muscular and skeletal disorders

Neurological

Other neurological disorders

Injuries and Accidents

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Change in wheelchair skills as shown on the Wheelchair Skills Test (WST) version 5.0. Measured pre and post intervention.

Timepoint [1]

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]

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]

Up to 21 days after the second group session at a time that is mutually agreed with the parent/guardian.

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato, Bay of Plenty, Lakes and Auckland

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Seating To Go

Address [1]

21 West St
PO Box 5725
Frankton, Hamilton. 3204

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health & Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
133 Molesworth St
PO Box 5013
Wellington. 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

14/03/2019

Approval date [1]

17/05/2019

Ethics approval number [1]

19/NTB/41

Summary

Brief summary

Wheelchairs are an effective rehabilitation intervention for people with serious mobility limitations, but provision of a wheelchair alone does not guarantee safe and effective use. Despite the known benefits of wheelchair skills training among adults, there is a dearth of research on wheelchair skills training for children.  The study investigates the effectiveness of peer led wheelchair skills training for children in New Zealand where Seating To Go have been providing peer-led wheelchair skills groups for a number of years in the Waikato, Bay of Plenty and Lakes regions, modeled on the Wheelchair Skills Programme developed through Dalhousie University, Canada.
The study hypothesis is that peer-led wheelchair skills groups will improve social participation, wheelchair skills and confidence of children who are wheelchair users.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Debbie Wilson

Address

Seating To Go
21 West St
PO Box 5725
Hamilton. 3204

Country

New Zealand

Phone

+64 272772571

Fax

deb@seatingtogo.co.nz

Contact person for public queries

Name

Debbie Wilson

Address

Seating To Go
21 West St
PO Box 5725
Hamilton. 3204

Country

New Zealand

Phone

+64 272772571

Fax

deb@seatingtogo.co.nz

Contact person for scientific queries

Name

Krista Best

Address

Postdoctoral Fellow
Universite Laval
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
525 Boulevard Wilfred-Hamil
Quebec

Country

Canada

Phone

+17788468390

Fax

krista-lynn.best.1@ulaval.ca

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
4332	Study protocol	deb@seatingtogo.co.nz
4333	Informed consent form	deb@seatingtogo.co.nz
4334	Ethical approval	deb@seatingtogo.co.nz
4335	Analytic code	deb@seatingtogo.co.nz
4336	Statistical analysis plan	deb@seatingtogo.co.nz

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically