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Speech Motor Treatment in Cerebral Palsy

NCT04189159 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-20

No results posted yet for this study

Summary

Cerebral palsy (CP) is the most frequent cause of motor disability worldwide, with a prevalence of 2-2.5 per 1000 live births. Children with CP may experience a variety of difficulties with communication including speech. Communication impairment has been identified in at least 40% of children with CP, with 36-90% of CP children experiencing motor speech impairment.

The aims of the current project are to test the effectiveness of intensive PROMPT treatment in a group of preschool children with CP and motor speech disorders (dysarthria/apraxia of speech) and to evaluate differences to the intervention response according to CP type, brain lesion severity and white matter integrity of corticospinal tract. We hypothesize that children with CP and motor speech disorders will benefit from 3 weeks of daily administration of PROMPT treatment and show measurable improvement of speech intelligibility on clinical and kinematic assessments, with 3 months stability. Outcome measures will include a standardized speech motor assessment as well as improvement in kinematic speech measures detected by a computerized system. We also hypothesize that children with dyskynetic CP will show more improvement induced by the PROMPT treatment as compared to children with spastic CP. We finally hypothesize that corticospinal microstructural integrity positively impact on intelligibility recovery, with children with better integrity having bigger improvements.

Our study of PROMPT with children with varying types of CP meets current international priorities of testing and implementing effective, earlier interventions, therefore investing in the improvement infant's health based on evidence, as a future investment for individuals and the community.

Conditions

  • Cerebral Palsy
  • Dysarthria

Interventions

BEHAVIORAL

PROMPT

PROMPT treatment is consistent with the principles of motor learning, in that every session includes a blocked pre-practice followed by variable and distributed practice and a gradual, hierarchical increase of complexity. Speech motor goals are integrated in goals for language and functional communication. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided, in order to shape speech movements, to give information on sequencing and timing and to introduce constraints for the reduction of degrees of freedom at the articulators' level in favour of motor control.

Sponsors & Collaborators

  • IRCCS Fondazione Stella Maris

    lead OTHER

Principal Investigators

  • Simona Fiori, MD, PhD · IRCCS Stella Maris Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189159 on ClinicalTrials.gov