ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614001276640

Ethics application status

Approved

Date submitted

25/11/2014

Date registered

5/12/2014

Date last updated

11/03/2021

Date data sharing statement initially provided

18/07/2019

Date results provided

18/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Minimising impairment: A multicentre randomized controlled trial of upper limb orthoses for children with cerebral palsy.

Scientific title

Does wearing a rigid upper limb wrist hand orthosis in combination with evidence informed occupational therapy, compared to evidence informed occupational therapy alone, reduce wrist/hand impairment and improve activity and participation outcomes in children aged 5-15 years with cerebral palsy?

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1164-0572

Trial acronym

Minimising impairment trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Children with cerebral palsy

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The treatment group will receive a custom-made serially adjustable rigid wrist/hand orthosis (WHO) to maintain the flexor compartment (muscles of the wrist, fingers and thumb) in a lengthened position to avoid shortening of the musculo-tendinous unit and other soft tissue.
Children will be asked to wear the splint overnight, or for a minimum of 6 hours during the night or day (nightly/daily), for the three years of the study, to achieve a prolonged positioning effect with the orthosis. Although night time wear is recommended, for some children it may be appropriate to wear the orthosis during the day.
An App (iPhone and android compatible) will be used to monitor factors such as the use of orthoses and any adverse events, based on parent report. Parents will receive a weekly text-reminder to record therapy received in the past week using simple response formats.
Data recorded on the App will be supplemented through a 6-monthly parent interview conducted by the site based research assistant to record additional details about the usual evidence-informed therapy their child received in the preceding period.
All children (regardless of group allocation) will receive care typically provided by their usual treating organisation. Possible treatments may include developmentally appropriate, goal focused and evidence-informed occupational therapy, the use of equipment or BoNT-A injections.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The control group will not receive a rigid wrist/hand orthosis.
All children (regardless of group allocation) will receive care typically provided by their usual treating organisation. Possible treatments may include developmentally appropriate, goal focused and evidence-informed occupational therapy, the use of equipment or BoNT-A injections.

Control group

Active

Outcomes

Primary outcome [1]

Passive range of passive wrist extension (measured with the fingers extended) measured using a goniometer

Timepoint [1]

3 Years

Primary outcome [2]

Active range of wrist movement measured using standardised goniometric measurement and use of clinometer for measures of supination and inertial motion sensors

Timepoint [2]

3 Years

Secondary outcome [1]

Body function outcomes:
Muscle tone (finger flexors, wrist extensors, pronators and elbow flexors) measured using Modified Ashworth Scale (Boyd et al, 1999);

Timepoint [1]

3 Years

Secondary outcome [2]

Body function outcomes:
Muscle spasticity (finger flexors, wrist extensors, pronators and elbow flexors), measured using Modified Tardieu Scale;

Timepoint [2]

3 Years

Secondary outcome [3]

Body function outcomes:
Grip Strength measured using hand held dynamometer Merlini et al. 2002);

Timepoint [3]

3 Years

Secondary outcome [4]

Body function outcomes:
Hand deformity measured using the Neurological Hand Deformity Classification (Wilton 2004);

Timepoint [4]

3 Years

Secondary outcome [5]

Body function measures:
Pain measured using a study specific questionnaire

Timepoint [5]

3 years

Secondary outcome [6]

Activity level outcomes:
Self care skills measured using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT; Haley, et al. 2011);

Timepoint [6]

3 years

Secondary outcome [7]

Activity level outcomes:
Manual Ability measured using ABILHAND-Kids (Arnould, et al. 2004);

Timepoint [7]

3 years

Secondary outcome [8]

Activity level outcomes:
Speed and dexterity measured using Box and Blocks Test (Mathiowetz et al. 1985);

Timepoint [8]

3 years

Secondary outcome [9]

Activity level outcomes:
Hand function measured using the Modified House Scale (Geerdink et al. 2014);

Timepoint [9]

3 years

Secondary outcome [10]

Activity level outcomes:
Ease of care measured using a study specific questionnaire.

Timepoint [10]

3 years

Secondary outcome [11]

Participation outcomes:
measured using the Participation and Environment Measure for Children and Youth (PEM-CY; Coster et al. 2011)

Timepoint [11]

3 years

Secondary outcome [12]

Quality of life outcomes measured using:
Quality of life: Cerebral Palsy Quality of Life Questionnaire - Child and Teen versions (Waters et al. 2007; Davis et al. 2013)
Assessing quality of life AQoL-8D - multi-attribute utility instrument (Richardson et al. 2014)

Timepoint [12]

3 years

Secondary outcome [13]

Relative cost and cost effectiveness measured using pathway analysis to document treatment activity, specify unit prices and estimate costs and potential cost offsets across the arms of the trial. Costs will be assessed by expenditure category (salaries; capital; overheads; consumables; etc.) as well as incidence (i.e. who bears the cost).

Timepoint [13]

3 years

Eligibility

Key inclusion criteria

A confirmed diagnosis of cerebral palsy as recorded in the medical history;
Aged 5-15 years;
Presence of flexor muscle stiffness - score at least 1 on the Modified Ashworth Scale during wrist extension with fingers extended;
May or may not already exhibit contracture at the wrist.

Minimum age

5 Years

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Dystonic, rather than spastic, motor disorder;
Allergy/sensitivity to splinting material;
Upper limb surgery during the study period or in the 12 months preceding study commencement;
Significant child refusal to comply with splint wearing schedule;
Family inability to access the study assessment or treatment site (due to geography).

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 treating clinical teams at each trial site will identify potential participants and provide written information about the study (Recruitment letter/ study advertisement /Participant Information Statements) and briefly discuss the study with the family. Families will also be advised of the study by site-specific newsletters, websites and social media with an invitation to contact study personnel or treating therapists for more information about the studies. Through discussion and clinical examination of the upper limb/s, eligibility will be determined and informed consent sought from the parent(s)/guardian of the child.

Once consent has been obtained, and following baseline assessment, children will be randomised to either the treatment or comparison group with an allocation ratio of 1:1. The randomisation schedule and web-based service will be provided by the Clinical Epidemiology and Biostatistics Unit (CEBU) at the Murdoch Childrens Research Institute and concealed from the researchers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence will be generated using a web-based procedure and will be in randomly permuted blocks of variable length, stratified by study centre, and by severity of passive wrist range.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The original primary research question to be addressed was:
- In children aged 5-15 years with cerebral palsy, does the provision of a serially adjustable rigid wrist/hand orthosis (WHO) in combination with usual multi-disciplinary care, compared to usual multi-disciplinary care alone: reduce body function and structure impairment including contracture, defined as fixed loss of range of movement; prevent further loss of range of movement at the wrist; and reduce pain and muscle stiffness across a three year period?

Since there are insufficient data collected on these outcomes at 36 months (only 1 child reached the 36 months assessment when the study was interrupted), it will not be possible to answer the research question as it was originally stated, with sufficient power. However, we are still interested in exploring how the provision of a rigid WHO in combination with usual multi-disciplinary care, compared to usual multi-disciplinary care alone, changes the passive range of movement or prevents further loss of movement at the wrist (wrist extension) across the duration of the study. Comparison between the intervention and the control groups in the passive range of wrist extension will be presented as the mean difference and its 95% confidence interval (CI), obtained using a repeated measures two level mixed model, where the repeated measures over time are nested within limbs (level-1) which are nested within children (level-2).

The original secondary research questions to be addressed were:
- In children aged 5-15 years, does the provision of a rigid WHO in combination with usual multi-disciplinary care, compared to usual multi-disciplinary care alone, reduce or prevent further development of muscle stiffness, pain and improve activity performance and/or ease of care across a three-year period?
- In children aged 5-15 years, does the provision of a rigid WHO, in combination with usual multi-disciplinary care, result in greater participation and quality of life outcomes compared to usual multi-disciplinary care alone?
- In children aged 5-15 years, what are the effects of the interaction between age and the provision of a rigid WHO in combination with usual multi-disciplinary care, and the interaction between severity and the provision of a rigid WHO in combination with usual multi-disciplinary care, compared to usual multi-disciplinary care alone, in reducing or preventing further development of muscle stiffness and pain, and improving activity performance and/or ease of care at three years from baseline?

Since there are insufficient data collected on any outcome at 3 years, we will explore how provision of a rigid WHO in combination with usual multi-disciplinary care, compared to usual multi-disciplinary care alone, changes the development of muscle stiffness, pain, activity performance, ease of care, participation and quality of life outcomes, across the duration of the study.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Participant recruitment difficulties

Date of first participant enrolment

Anticipated

5/01/2015

Actual

28/08/2015

Date of last participant enrolment

Anticipated

30/12/2018

Actual

1/12/2017

Date of last data collection

Anticipated

31/08/2018

Actual

20/12/2018

Sample size

Target

194

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment hospital [2]

Princess Margaret Hospital - Subiaco

Recruitment hospital [3]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [4]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

6008 - Subiaco

Recruitment postcode(s) [3]

3168 - Clayton

Recruitment postcode(s) [4]

2100 - Allambie

Recruitment postcode(s) [5]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

PO Box 968 North Sydney NSW 2059

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Centre, Australia

Address [2]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

Individual

Name

Christine Imms

Address

Australian Catholic University
Level 2, Daniel Mannix Building,
17 Young Street, Fitzroy VIC 3065

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Margaret Wallen

Address [1]

The Cerebral Palsy Alliance
187 Allambie Rd,
Allambie Heights, NSW 2100, Australia

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Catherine Elliott

Address [2]

Department of Paediatric Rehabilitation
Princess Margaret Hospital for Children
Roberts Road,
Subiaco WA 6008

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Brian Hoare

Address [3]

Monash Medical Centre
246 Clayton Rd,
Clayton VIC 3168

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Susan Greaves

Address [4]

The Royal Children's Hospital
Flemington Road,
Parkville, 3052 Victoria,

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Medical Centre

Ethics committee address [1]

246 Clayton Rd, Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/10/2014

Ethics approval number [1]

14199B

Ethics committee name [2]

Perth Children's Hospital

Ethics committee address [2]

Perth Children's Hospital
15 Hospital Avenue, Nedlands
Western Australia 6009

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

02/06/2014

Approval date [2]

25/11/2014

Ethics approval number [2]

2014060

Ethics committee name [3]

The Cerebral Palsy Alliance

Ethics committee address [3]

187 Allambie Road Allambie Heights New South Wales Australia 2100

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

18/07/2014

Approval date [3]

04/09/2014

Ethics approval number [3]

2014-08-02

Ethics committee name [4]

Australian Catholic University

Ethics committee address [4]

PO Box 968 North Sydney NSW 2059

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

11/11/2014

Approval date [4]

24/11/2014

Ethics approval number [4]

2014 317V

Ethics committee name [5]

The Royal Children's Hospital Melbourne

Ethics committee address [5]

Fleminton Road 
Parkville, 3052 VIC

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

25/11/2014

Approval date [5]

08/05/2015

Ethics approval number [5]

RCH HREC- 34280A

Summary

Brief summary

We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for children with cerebral palsy. This trial aims to maintain and/or increase range of movement in the wrist thumb and fingers of children aged 5-15 years.

Trial website

http://www.cre-cp.org.au/research/current-research-projects/upper-limb-orthoses/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Christine Imms

Address

University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia

Country

Australia

Phone

+61393454953

Fax

[email protected]

Contact person for public queries

Name

Christine Imms

Address

University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia

Country

Australia

Phone

+61393454953

Fax

[email protected]

Contact person for scientific queries

Name

Christine Imms

Address

University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia

Country

Australia

Phone

+61393454953

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

Not included in original consent.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3111	Study protocol	Imms, C., Wallen, M., Elliott, C., Hoare, B., Randall, M., Greaves, S., Adair, B., Bradshaw, E., Orsini, F., Carter, R., Shih, S.T.F., & Reddihough, D. (2016). Minimising impairment: Protocol for a multicenter randomized controlled trial of upper limb orthoses for children with cerebral palsy. BMC Pediatrics, 16:70.	https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0608-8

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Imms, C., et al. (2022). "Implications of providin... [More Details]	367398-(Uploaded-27-09-2022-14-13-24)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically