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Does the use of a specific cognitive intervention for children with movement disorders improve functional outcomes following deep brain stimulation?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57997252
Enrollment
36
Registered
2016-03-09
Start date
2014-09-25
Completion date
Unknown
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Children, Neurological

Interventions

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 chil

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactHortensia Gimeno

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026