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Trial registered on ANZCTR


Registration number
ACTRN12622001563752
Ethics application status
Approved
Date submitted
25/10/2022
Date registered
19/12/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an adaptive seating device on upper extremity function among children with cerebral palsy
Scientific title
The effect of an adaptive seating device compared to standard care on upper limb function in children with cerebral palsy: a randomised controlled trial
Secondary ID [1] 308251 0
PRG06421 (Cerebral Palsy Alliance grant number)
Universal Trial Number (UTN)
U1111-1282-2844
Trial acronym

Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 328034 0
Condition category
Condition code
Neurological 325092 325092 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of treatment. Treatment will consist of the daily use of a custom-built adaptive seating device with opportunities to spontaneously handle objects and interact with others for 3 weeks. A local seating engineer trained by the Asian Seating Assistance Project (ASAP) staff will build the seat using local materials. The adaptive seating device consists of a chair that:
• can be tilt-in-space by 30°
• is customised to the physical body dimensions of the child
• includes a pelvic and chest strap
• includes a foot and back rest
• allows a table to be attached for use in play, eating, writing, drawing, etc.
• will be waterproof, easy to transport and detachable, light weight (~5 kg), and is padded
Children in the treatment group will be assessed by a physiotherapist and measured for the adaptive seating device. The device will be delivered to the child, and the child and their family will be instructed by the same therapist in how to use the device in their home setting. They will be encouraged to sit the child in the chair for 6 hours per day. Adherence to the seating regime and total time spent sitting in the adaptive device will be monitored by the therapist or a research assistant via weekly phone contact.
The overall duration for the responding outcome measures will take around one and half hour. The treatment protocol follow the Michelle Jackman the Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. The intervention duration might vary depending on the child ability, age, goals, resources, and family involvement but the maximum duration will be two hours a day for five days in a week.
Intervention code [1] 324711 0
Treatment: Devices
Comparator / control treatment
The control group will receive a standard chair with pelvic and chest strap for child safety. The child will be assessed by a physiotherapist and measured for the standard chair. The chair will be delivered to the child, and the child and their family will be instructed in how to use the chair daily and encouraged to sit the child in the chair for 6 hours per day. Adherence to the seating regime and total time spent sitting in the adaptive device will be monitored by the therapist or a research assistant via weekly phone contact.
The intervention chair consist of back and foot rest with round table attached on the chair. it can be adjusted forward and backward with tilt-in space whereas the standard chair is not adjustable.
The parents will be trained for the safety of child while using the chair and they will be followed once in a week via phone call. The overall duration for the responding outcome measures will take around one and half hour. The treatment protocol for the control group will also follow the Michelle Jackman the Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. The intervention duration might vary depending on the child ability, age, goals, resources, and family involvement but the maximum duration will be two hours a day for five days in a week.
Control group
Active

Outcomes
Primary outcome [1] 332902 0
The primary outcome will be assessed using the Nepali translation of the adapted Canadian Occupational Performance Measure (COPM) questionnaire. This scores the parent’s perceived functional capacity of the child to manage up to five self-selected functional tasks. The parents rate each item based on the child’s ability on a scale of 1-10. A ‘1’ indicates poor performance and low satisfaction, while ‘10’ indicates very good performance and high satisfaction. An average COPM performance score and satisfaction score is then calculated. Higher average COPM score indicates increased performance and satisfaction.
Timepoint [1] 332902 0
Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.
Secondary outcome [1] 415056 0
• Quality of life
This outcome will be assessed using the Nepali version of the Pediatric Quality of Life Inventory (PedsQL) parents and child rated questionnaires. Higher scores indicate better quality of life of the child.

Timepoint [1] 415056 0
Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.
Secondary outcome [2] 415057 0
• Impact on the family.
This outcome will be assessed using the Family Impact of Assistive Technology Scale for Adaptive Seating (FIATS-AS) questionnaire. Higher score indicate the positive impact of low-cost adaptive seating devices.
Timepoint [2] 415057 0
Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.
Secondary outcome [3] 415058 0
• Hand function will be measured using the Nepali translation of the ABILHAND-Kids questionnaire. This scores the parent’s perceived functional capacity of the child to manage daily activities that require the use of the upper limb. The parents rate each item based on the child’s ability as “Impossible”, “Difficult” or “Easy”. Activities which are not performed in 3 weeks are not scored and entered as “N/A”.
Timepoint [3] 415058 0
Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.

Eligibility
Key inclusion criteria
• 60 children with cerebral palsy (CP) of any motor type and topography
• Gross Motor Functional Classification System (GMFCS) III-V
• aged 5-16 years
• adaptive seating intervention naïve, including not been supplied with or used a corner seat. (This may mean that they have been left on the floor for most of the day or they may have been placed in various forms of seating for feeding etc by parents. This will be confirmed by history taking at the initial assessment and recorded in our data collection sheets.)
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Uncontrolled epilepsy or drug resistant epilepsy (International League Against Epilepsy criteria)
• Vision impairment
• Ventilator dependent

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)
The allocation schedule will be generated using a computer and held by an investigator based offsite who is not involved in data collection or data analysis. After each participant's initial visit and only after measurements for a chair have been taken, their allocation will be given to the treating therapist by the investigator based offsite.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation stratified by GMFCS scores, generated using a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For primary and secondary outcomes, analysis of covariance (ANCOVA) will be performed to obtain a between-group mean difference by regressing follow-up scores on group and baseline scores. Between-group mean differences (95% CI) for each outcome will be reported. Descriptive data within groups will be summarized . There are no existing pilot studies on the effect of adaptive seating on physical function in children with CP. A sample size of 26 children in each group (total = 52 children) provides 80% power to detect a large, standardised effect of 0.8 (SD 1.0) at 80% power, alpha = 0.05. We will recruit to 30 children in each group (total = 60 children) to account for loss to follow up or poor-quality data.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
2/01/2023
Actual
30/12/2023
Date of last participant enrolment
Anticipated
6/02/2023
Actual
30/12/2023
Date of last data collection
Anticipated
29/12/2024
Actual
Sample size
Target
60
Accrual to date
28
Final
Recruitment outside Australia
Country [1] 25079 0
Nepal
State/province [1] 25079 0
Karnali Province, Bagmati province, Lumbani province

Funding & Sponsors
Funding source category [1] 312507 0
Charities/Societies/Foundations
Name [1] 312507 0
Cerebral Palsy Research Alliance
Country [1] 312507 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cerebral Palsy Research Alliance
Address
Cerebral Palsy Research Alliance, Australia. 187 Allambie Road, Allambie Heights NSW 2100
Country
Australia
Secondary sponsor category [1] 314100 0
University
Name [1] 314100 0
Karnali Academy of Health Sciences, Jumla, Nepal
Address [1] 314100 0
Karnali Academy of Health Sciences, Chandanath Municipality Jumla, Hospital Road- 5, Karnali Province, Nepal

Postal code: 21200
Country [1] 314100 0
Nepal
Secondary sponsor category [2] 314101 0
University
Name [2] 314101 0
Curtin University
Address [2] 314101 0
The University of Sydney
Camperdown NSW 2006
Australia
Country [2] 314101 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311843 0
Nepal Health Research Council
Ethics committee address [1] 311843 0
Nepal Health Research Council, Ramshah Path, Kathmandu, Nepal.
Street: Ramshapath, Postal code: 44600
Ethics committee country [1] 311843 0
Nepal
Date submitted for ethics approval [1] 311843 0
26/07/2022
Approval date [1] 311843 0
16/09/2022
Ethics approval number [1] 311843 0
35912022 P

Summary
Brief summary
Cerebral palsy (CP) is a heterogeneous group of permanent unchanging disorders of the developing brain and is the primary cause of motor disability among children globally. The estimated occurrence of CP varies but the prevalence is suggested to be higher in developing countries.
The major cause of movement impairment among children with CP is damage to the motor system. Children with markedly impaired motor ability that are non-ambulant commonly have severely affected postural control in upright sitting. To enable upright sitting, children with CP require a support system that promotes inclusion and hand use and may prevent further deterioration of musculoskeletal alignment and associated complications. Evidence suggests the use of modified seating systems promotes postural correction and decreases long-term musculoskeletal complications. Low-quality evidence has shown that adaptive seating devices play an important role in the child’s functioning, interaction with the environment and friends, easing parental care and promoting a feeling of independence. It is estimated 40% of children with CP who are non-ambulant require the long-term use of an adaptive seating system.
In low-middle income countries like Nepal there are many children with CP who have no access to seating systems due to the prohibitory costs or the unavailability of any suitable locally produced seating system. The provision of low-cost adaptive seating would greatly benefit this very vulnerable population. We hypothesis that compared with usual care (no adaptive seating intervention), provision of a customised adaptive seat will increase the total score on the ‘adapted’ Canadian Occupational Performance Measure (COPM Nepalese version) by a difference of >2.
While there is evidence to suggest adaptive seating is beneficial, no randomized controlled trial has been conducted to investigate whether these devices improve upper limb function, quality of life of the children with CP or decrease caregiver burden. Therefore, this project will be the first study to conduct a randomized controlled trial investigating the effects of a low-cost adaptive seating system that is feasible to use in Nepal, in children with CP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122566 0
Mr Bishnu Dutta Acharya
Address 122566 0
Karnali Academy of Health Sciences, Hospital Road-5, Chandanath Municipality, Jumla, Nepal. Postal code: 21200
Country 122566 0
Nepal
Phone 122566 0
+9779849746204
Fax 122566 0
Email 122566 0
[email protected]
Contact person for public queries
Name 122567 0
Darren Reed.
Address 122567 0
The University of Sydney, Camperdown NSW 2006, School of Medical Sciences, Faculty of Medicine and Health.
Country 122567 0
Australia
Phone 122567 0
+61 02 8627 8869
Fax 122567 0
Email 122567 0
[email protected]
Contact person for scientific queries
Name 122568 0
Joanna Diong
Address 122568 0
The University of Sydney, Camperdown NSW 2006, School of Medical Sciences, Faculty of Medicine and Health.
Country 122568 0
Australia
Phone 122568 0
+61 02 8627 5491
Fax 122568 0
Email 122568 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17445Other  [email protected] On request



Results publications and other study-related documents

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