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Clinical Trials/NL-OMON30394
NL-OMON30394
Not yet recruiting
Not Applicable

The development and evaluation of a behavioural program to treat drooling in children wit Cerebral Palsy - Behaviour therapy for drooling in CP

Sint Maartenskliniek0 sites20 target enrollmentTBD
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Conditionscerebral palsy10014623

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
cerebral palsy
Sponsor
Sint Maartenskliniek
Enrollment
20
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •· a confirmed diagnosis of CP, with detailed descriptions of movement impairment;
  • •· drooling severity: Teacher Drool Scale (TDS: Camp\-Bruno et al., 1989\) score 3 (occasional drooling; intermittent all day) or more (4: frequent drooling; but not profuse; 5: constant drooling; always wet);
  • •· developmental age \>\= 6 years; the child displays reasonable awareness of the practical and/or social consequences of drooling;
  • •· the child has the ability to close his/her mouth and swallow on demand;
  • •· the child has the ability to remain seated (or is able to correct seating position independently);
  • •· the child has the ability to wipe the mouth/chin;
  • •· the child is susceptible to social and/or material reinforcers;
  • •· medication to treat drooling stopped at least 3 months before inclusion;
  • •· the parents and teachers are willing to participate in the treatment program, i.e. to perform activities to maintain the training effect.
  • •· the child and their parents and teachers are willing to participate in scientific research, including activities for data\-collection (informed consent is obtained) and if significant positive changes are established are prepared to refrain from other medical treatment for 6 months after the end of the training.

Exclusion Criteria

  • •· the child has uncontrollable (epileptic) seizures;
  • •· the child has severe aggressive or hyperactive behaviour;
  • •· during 6 months before inclusion there has been surgery or botulinum toxin injection

Outcomes

Primary Outcomes

Not specified

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