Condition category
Nervous System Diseases
Date applied
09/03/2016
Date assigned
09/03/2016
Last edited
14/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Movement disorders are a collection of conditions which affect the speed, fluency, quality, and ease of movement. They are typically divided into two categories: hyperkinetic (disorders of excessive movement) and hypokinetic (disorders in which there is slowness or absence of movement. Hyperkinetic movement disorders (HMD) include a range of involuntary movement, including dystonia (muscle spasms which cause twisting, repetitive movements and poor posture), chorea (jerky movements which are irregular and unpredictable), athetosis (muscle contractions causing writhing movements), myoclonus (sudden contraction of a group of muscles) and tremor (uncontrolled shaking). Conditions such as these can make everyday activities such as washing and dressing very difficult, making it very hard for those affected to look after themselves, which can affect their independence later in life. Many children with HMD undergo a type of treatment called deep brain stimulation (DBS) which can help to ease the symptoms and reduce pain caused by abnormal movements. Children and young people with HMD who are able to get involved in daily activities often have difficulties doing so, even after DBS. However, very little is known about other aspects that may influence children’s and young people’s ability to improve their skills required for living and learning. Treatments such as occupational therapy (working with a therapist who can help to maintain, regain or improve independence using different techniques and equipment) could potential help children with HMD when offered with DBS. Cognitive orientation to occupational performance (CO-OP) is a type of occupational therapy which helps people who have difficulties performing everyday skills. The aim of this study is to find out whether the CO-OP approach can be used to treat children with HMD and if this treatment approach is acceptable to families.

Who can participate?
Patients aged between 6 and 21 who have a hyperkinetic movement disorder

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the control group continue to receive treatment as usual for the duration of the study, which might include equipment provision, occupational therapy or physiotherapy. Participants in the intervention group are visited by an occupational therapist trained in CO- OP for up to 10 sessions, lasting for 45 minutes to one hour, once or twice a week at the child’s home. All participants are assessed at the start and end of the treatment and at 3 months follow up.

What are the possible benefits and risks of participating?
There is a possibility that participants will benefit from a reduction in the HMD symptoms. There are no notable risks involved with taking part in this study.

Where is the study run from?
Evelina Children's Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2014 to February 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Farhiya Ashoor

Trial website

Contact information

Type

Public

Primary contact

Ms Hortensia Gimeno

ORCID ID

Contact details

Guy's and St. Thomas' NHS Foundation Trust
Evelina Children's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17472

Study information

Scientific title

Randomised controlled trial using the cognitive orientation to occupational performance (CO-OP) intervention with paediatric hyperkinetic movement disorders following deep brain stimulation (DBS): a feasibility study

Acronym

Study hypothesis

The aim of the study is to explore whether cognitive orientation to occupational performance (CO-OP) could be used to treat children with hyperkinetic movement disorders (HMD) and whether the treatment approach would be acceptable to families.

Ethics approval

South Central - Oxford A Research Ethics Committee, 26/08/2014, ref: 14/SC/1159

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children, Neurological; Subtopic: Children (all Diagnoses), Neurological (all Subtopics); Disease: All Diseases, Neuro-muscular and Encephalitis

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: A trained occupational therapist on cognitive orientation to daily occupational performance (CO- OP), will visit the child's home to complete the intervention. CO-OP will be implemented with the child and main carers will be asked to be present so that the strategies and general approach can be implemented on a daily basis. When necessary written instructions will be provided for the child and/or family. The CO-OP intervention will employ the treatment manual produced after the developmental phase so that if several treating therapists employed, adherence to the protocol can be ensured. There will be up to 10 CO-OP sessions, lasting for 45 minutes to one hour, delivered once or twice a week. The sessions will be completed in the child’s natural environment (i.e., home). The sessions will be videoed and a random session chosen for scoring of therapist adherence to the protocol by a CO-OP expert.

Control group: Participants continue to receive treatment as usual for the duration of the study. This might include equipment provision, occupational therapy or physiotherapy.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Quality of functional performance for chosen goals is measured using the Performance Quality Rating Scale (PQRS) at baseline, post-intervention and 3 months follow up.

Secondary outcome measures

1. Typical performance is measured using the Assessment of Motor and Process Skills (AMPS) questionnaire is measured at baseline, post intervention and 3 months follow up
2. Executive Function (Proxy reported) is measured using the Behaviour Rating Inventory of Executive Function (BRIEF) is measured at baseline, post intervention and 3 months follow up
3. Dystonia impairment is measured using the Burke-Fahn-Marsden Dystonia Rating Scale is measured at baseline, post intervention and 3 months follow up up
4. Goal acquisition (self-reported) is measured using the Canadian Occupational Performance Measure (COPM) is measured at baseline, post intervention and 3 months follow up
5. Executive function is measured using the Colour Word Interference Test is measured at baseline, post intervention and 3 months follow up
6. Executive function is measured using the Comprehensive Trail Making Test (CTMT) is measured at baseline, post intervention and 3 months follow up
7. Quality of life is measured using the EQ-5D is measured measured at baseline, post intervention and 3 months follow up
8. Goal acquisition is measured using the Goal Attainment Scale (GAS) is measured at baseline, post intervention and 3 months follow up
9. Self-care and mobility function ability (proxy reported) is measured using the Pediatric Evaluation of Disability Inventory Computerised Assessment Tool (PEDI-CAT) is measured at baseline, post intervention and 3 months follow up
10. Self efficacy (self-reported) is measured using the Self-Efficacy Gauge Measure - Paediatrics is measured at baseline, post intervention and 3 months follow up
11. Anxiety (self and proxy reported) is measured using the Spence Children's Anxiety Scale (parent and child versions) is measured at baseline, post intervention and 3 months follow up
12. Adaptive behaviour (proxy reported) is measured using the Adaptive Behavior Assessment System (ABAS) is measured at baseline, post intervention and 3 months follow up

Overall trial start date

25/09/2014

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants must express and evidence a willingness to participate
2. Sufficient receptive and expressive communication ability to follow simple instructions and engagement with treatment (including adequacy of English language)
3. Diagnosis of hyperkinetic movement disorder other than neurodegenerative conditions
4. Age 6-21 years
5. Manual Ability and Classification System (17) (MACS) levels IIII
6. Emerging skills in self-care such as starting to want to get undressed, brush own teeth, self-feed
7. Ability to mobilize independently
8. Requiring adult assistance to complete age appropriate activities. e.g. eating and drinking, toothbrushing, washing and dressing, making a sandwich, making a bed, etc
9. Cognitive ability of 6 years of age and IQ above 70 as assessed using the Wechsler Intelligence Scale for Children (WISC)
10. Deep Brain Stimulation in situ and without signs of infection

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 36; UK Sample Size: 36

Participant exclusion criteria

1. Pure spasticity or mixed phenotype when spasticity is dominant feature;
2. Dystonia arising due to a neurodegenerative condition
3. Scheduled for surgical treatment in the study period
4. Known signs of DBS infection

Recruitment start date

25/09/2014

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Evelina Children's Hospital
Complex Motor Disorders Service Guy's and St. Thomas' NHS Foundation Trust Lambeth Palace Road
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
Department of Psychology
Henry Wellcome Building
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination will take place during the study and not just at the end. We are planning to publish the trial protocol by May 2016. Results will be published for stage 1 first using n-of-1 trial data. Group data will be published separately. We anticipate this will be published by the end of 2016. Stage 2 will be published in 2017 after data analysis is completed. It is also hoped to present during the project duration at conferences such as:
1. British Paediatric Neurology Association (BPNA)
2. European Academy of Childhood Disability (EACD)
3,. Canadian Association of Occupational Therapists (CAOT)
4. National Children and Young People and Families Occupational Therapy Conference
Further, it is hoped to engage young people and families to help write some of the results

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/06/2016: Plain English summary added.