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Trial registered on ANZCTR


Registration number
ACTRN12618001732279
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
22/10/2018
Date last updated
20/04/2021
Date data sharing statement initially provided
20/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive strategies to improve outcomes for children with spinal cord injuries or disease
Scientific title
Cognitive strategies to improve outcomes for children with spinal cord injuries or disease
Secondary ID [1] 296349 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Daily function in children with spinal cord injuries or disease 310068 0
School function in children with spinal cord injuries or disease 310069 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308823 308823 0 0
Occupational therapy
Musculoskeletal 308860 308860 0 0
Other muscular and skeletal disorders
Injuries and Accidents 308861 308861 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A program incorporating evidence-based strategies of self-regulation and imagery building into enhancing people’s daily and school task performance will be developed.

The Self-Regulation and Mental Imagery (SReMI) group will form the experimental group. Children with spinal cord injuries or disease will receive the newly validated SReMI program. The SReMI intervention will consist of a 12-week program of one 60-minute therapist-led session and two home sessions per week. The child will undergo individual session and be guided to use self-regulation to identify the problems in performing daily or school tasks and find an appropriate solution to solve the problems. He/she will then guide to use imagery to mentally practice the tasks. This is done together with the actual practice of the tasks. The intervention consists of 15 daily and school tasks. The child is guided by the rehabilitation worker throughout the process. During the home session, the child will record on their practice on a log book.
Intervention code [1] 312678 0
Rehabilitation
Comparator / control treatment
The control group will receive an activity-based intervention. The frequency and duration of the control group will be consistent with the SReMI program. The activity-based intervention focused on three main activities: i) construction, ii) drawing and iii) crafts. The program consisted of a 20-minute construction activity, a 15-minute drawing activity, five minutes rest and a 20-minute craft activity.
Control group
Active

Outcomes
Primary outcome [1] 307797 0
School Function Assessment
Timepoint [1] 307797 0
Before the program, at 12 weeks (primary timepoint) and 20 weeks.
Primary outcome [2] 307798 0
Pediatric Evaluation of Disability Inventory
Timepoint [2] 307798 0
Before the program, at 12 (primary timepoint) and 20 weeks.
Secondary outcome [1] 352940 0
Barthel Index
Timepoint [1] 352940 0
Before the program, at 12 and 20 weeks.
Secondary outcome [2] 352941 0
Assessment of Motor and Process Skills
Timepoint [2] 352941 0
Before the program, at 12 and 20 weeks
Secondary outcome [3] 352942 0
Canadian Occupational Performance Measure
Timepoint [3] 352942 0
Before the program, at 12 and 20 weeks
Secondary outcome [4] 352943 0
Spinal Cord Independence measure-III self report for youth
Timepoint [4] 352943 0
Before the program, at 12 and 20 weeks
Secondary outcome [5] 352944 0
Wheelchair Skills Test
Timepoint [5] 352944 0
Before the program, at 12 and 20 weeks.

Eligibility
Key inclusion criteria
• Aged 6 to 18
• Have any form of spinal cord injuries or disease
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants are randomised using a computer-generated randomisation table. The allocation is completed by the holder of the allocation schedule who is not involved in conducting assessments or providing interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measure multivariate analysis of variance test will be used to test the benefit and the carryover effect of the program on the school and daily functions of the children. Between-group comparisons will also be conducted to compare the benefits of the SReMI program and the control program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300951 0
University
Name [1] 300951 0
Western Sydney University
Country [1] 300951 0
Australia
Funding source category [2] 300952 0
Commercial sector/Industry
Name [2] 300952 0
SpinalCare Foundation, Northcott
Country [2] 300952 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SpinalCare Foundation, Northcott
Address
1 Fennell St, North Parramatta, NSW 2151
Country
Australia
Secondary sponsor category [1] 300524 0
University
Name [1] 300524 0
Western Sydney University
Address [1] 300524 0
Locked Bag 1797, Penrith NSW 2751
Country [1] 300524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301719 0
Western Sydney University Human Research Ethics Commitee
Ethics committee address [1] 301719 0
Ethics committee country [1] 301719 0
Australia
Date submitted for ethics approval [1] 301719 0
25/10/2018
Approval date [1] 301719 0
17/12/2018
Ethics approval number [1] 301719 0

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

Contacts
Principal investigator
Name 87874 0
Prof Karen Liu
Address 87874 0
Western Sydney University, Locked Bag 1797, Penrith NSW 2751
Country 87874 0
Australia
Phone 87874 0
+61 2 46203432
Fax 87874 0
Email 87874 0
karen.liu@westernsydney.edu.au
Contact person for public queries
Name 87875 0
Karen Liu
Address 87875 0
Western Sydney University, Locked Bag 1797, Penrith NSW 2751
Country 87875 0
Australia
Phone 87875 0
+61 2 46203432
Fax 87875 0
Email 87875 0
karen.liu@westernsydney.edu.au
Contact person for scientific queries
Name 87876 0
Karen Liu
Address 87876 0
Western Sydney University, Locked Bag 1797, Penrith NSW 2751
Country 87876 0
Australia
Phone 87876 0
+61 2 46203432
Fax 87876 0
Email 87876 0
karen.liu@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As the participant number is not high, it has a potential risk that the de-identified data may be identifiable. To avoid the possible risk, only the mean and standard deviation of the outcome measures collected will be available on reasonable request.


What supporting documents are/will be available?

No Supporting Document Provided



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.