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Clinical Trials/ISRCTN57997252
ISRCTN57997252
Completed
未知

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

King's College London (UK)0 sites36 target enrollmentMarch 9, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Children, Neurological
Sponsor
King's College London (UK)
Enrollment
36
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33375553/ (added 25/04/2023) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/30796136/ (added 25/04/2023) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33553070/ (added 25/04/2023)

Registry
who.int
Start Date
March 9, 2016
End Date
February 28, 2017
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
King's College London (UK)

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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