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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]

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

Condition category

Condition code

Neurological

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]

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]

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]

Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.

Secondary outcome [1]

• 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]

Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.

Secondary outcome [2]

• 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]

Initial assessment
Baseline assessment after 3 weeks
And 3 weeks later after providing the seating devices for final evaluation.

Secondary outcome [3]

• 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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Nepal

State/province [1]

Karnali Province, Bagmati province, Lumbani province

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cerebral Palsy Research Alliance

Address [1]

Cerebral Palsy Research Alliance, Australia. 187 Allambie Road, Allambie Heights NSW 2100

Country [1]

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]

University

Name [1]

Karnali Academy of Health Sciences, Jumla, Nepal

Address [1]

Karnali Academy of Health Sciences, Chandanath Municipality Jumla, Hospital Road- 5, Karnali Province, Nepal

Postal code: 21200

Country [1]

Nepal

Secondary sponsor category [2]

University

Name [2]

Curtin University

Address [2]

The University of Sydney
Camperdown NSW 2006
Australia

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nepal Health Research Council

Ethics committee address [1]

Nepal Health Research Council, Ramshah Path, Kathmandu, Nepal.
Street: Ramshapath, Postal code:  44600

Ethics committee country [1]

Nepal

Date submitted for ethics approval [1]

26/07/2022

Approval date [1]

16/09/2022

Ethics approval number [1]

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

Mr Bishnu Dutta Acharya

Address

Karnali Academy of Health Sciences, Hospital Road-5, Chandanath Municipality, Jumla, Nepal. Postal code: 21200

Country

Nepal

Phone

+9779849746204

Fax

mugaliacharya@gmail.com

Contact person for public queries

Name

Darren Reed.

Address

The University of Sydney, Camperdown NSW 2006, School of Medical Sciences, Faculty of Medicine and Health.

Country

Australia

Phone

+61 02 8627 8869

Fax

darren.reed@sydney.edu.au

Contact person for scientific queries

Name

Joanna Diong

Address

The University of Sydney, Camperdown NSW 2006, School of Medical Sciences, Faculty of Medicine and Health.

Country

Australia

Phone

+61 02 8627 5491

Fax

joanna.diong@sydney.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17445	Other			joanna.diong@sydney.edu.au	On request

Results publications and other study-related documents

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No additional documents have been identified.

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