Evidence map›Paper›PMID 27230616›Full record

Trial reportBMC pediatrics2016

Minimising impairment: Protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy.

Christine Imms, Margaret Wallen, Catherine Elliott, Brian Hoare, Melinda Randall, Susan Greaves, Brooke Adair, Elizabeth Bradshaw, Rob Carter, Francesca Orsini and 2 more

Open access · goldAbstract readMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Christine ImmsCentre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia. Christine.imms@acu.edu.au.
Margaret WallenCerebral Palsy Alliance, PO Box 6427, Frenchs Forest, NSW, 2086, Australia.
Catherine ElliottSchool of Occupational Therapy and Social Work, Curtin University, Bentley, Australia.
Brian HoareMonash Children's Hospital, Clayton, Australia.
Melinda RandallCentre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia.
Susan GreavesRoyal Children's Hospital, Flemington Rd, Parkville, 3052, Australia.
Brooke AdairCentre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia.
Elizabeth BradshawCentre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia.
Rob CarterDeakin University, Building BC, Room BC3.113, 221 Burwood Highway, Burwood, Australia.
Francesca OrsiniMurdoch Childrens Research Institute, Parkville, Australia.
Sophy T F ShihDeakin University, Building BC, Room BC3.113, 221 Burwood Highway, Burwood, Australia.
Dinah ReddihoughMurdoch Childrens Research Institute, Parkville, Australia.
Australian Catholic University · AUDeakin University · AUMurdoch Children's Research Institute · AUCerebral Palsy Alliance · AUCurtin University · AUMonash Children’s Hospital · AURoyal Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUpper limb orthoses are frequently prescribed for children with cerebral palsy (CP) who have muscle overactivity predominantly due to spasticity, with little evidence of long-term effectiveness. Clinical consensus is that orthoses help to preserve range of movement: nevertheless, they can be complex to construct, expensive, uncomfortable and require commitment from parents and children to wear. This protocol paper describes a randomised controlled trial to evaluate whether long-term use of rigid wrist/hand orthoses (WHO) in children with CP, combined with usual multidisciplinary care, can prevent or reduce musculoskeletal impairments, including muscle stiffness/tone and loss of movement range, compared to usual multidisciplinary care alone. METHODS/

designThis pragmatic, multicentre, assessor-blinded randomised controlled trial with economic analysis will recruit 194 children with CP, aged 5-15 years, who present with flexor muscle stiffness of the wrist and/or fingers/thumb (Modified Ashworth Scale score ≥1). Children, recruited from treatment centres in Victoria, New South Wales and Western Australia, will be randomised to groups (1:1 allocation) using concealed procedures. All children will receive care typically provided by their treating organisation. The treatment group will receive a custom-made serially adjustable rigid WHO, prescribed for 6 h nightly (or daily) to wear for 3 years. An application developed for mobile devices will monitor WHO wearing time and adverse events. The control group will not receive a WHO, and will cease wearing one if previously prescribed. Outcomes will be measured 6 monthly over a period of 3 years. The primary outcome is passive range of wrist extension, measured with fingers extended using a goniometer at 3 years. Secondary outcomes include muscle stiffness, spasticity, pain, grip strength and hand deformity. Activity, participation, quality of life, cost and cost-effectiveness will also be assessed. DISCUSSION: This study will provide evidence to inform clinicians, services, funding agencies and parents/carers of children with CP whether the provision of a rigid WHO to reduce upper limb impairment, in combination with usual multidisciplinary care, is worth the effort and costs.

trial registrationANZ Clinical Trials Registry: U1111-1164-0572 .

Indexed as

Orthotic DevicesAdolescentCerebral PalsyChildChild, PreschoolClinical ProtocolsCombined Modality TherapyFemaleFollow-Up StudiesHandHand StrengthHumansMaleOccupational TherapyPhysical Therapy ModalitiesProspective StudiesCerebral palsyChildrenCost-effectivenessInterventionOccupational therapyOrthosisRandomised trialSplintUpper extremity

Identifiers

PMID27230616
PMCPMC4882829
OpenAlexW2402220255

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.