Speech Motor Treatment in Cerebral Palsy

NCT04189159 | Unknown DMC

• 2 other identifiers: PROMPT-20192019 Motor Speech Grant
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cerebral palsy; dysartria; motor speech treatment; prompt

Outcome Measures

Primary Outcomes (4)

• Verbal Motor Production Assessment for Children (VMPAC)

  Standardized motor speech assessment, which includes 5 subscales, where higher scores mean better performance: Global motor control (range 20-0); Focal oromotor control (range 268-0); Sequencing (range 46-0); Connected speech and language (range 45-0); Speech Characteristics (range 7-0)

  after the end of treatment period (4 weeks from baseline)

• Phonetic Inventory

  motor speech measure

  after the end of treatment period (4 weeks from baseline)

• the Intelligibility in Context Scale - Italian version

  motor speech measure, range 1-5, where higher scores mean better performances

  after the end of treatment period (4 weeks from baseline)

• Viking Speech Scale (VSS)

  Ordinal scale for intelligibility, range 1-4, with lower scores corresponding to better performances

  after the end of treatment period (4 weeks from baseline)

Secondary Outcomes (1)

• kinematic speech motor measures

  after the end of treatment period (4 weeks from baseline)

Study Arms (2)

PROMPT Treated

EXPERIMENTAL

PROMPT treatment, twice a day, for 5 days a week, for 3 consecutive weeks

Behavioral: PROMPT

Control

NO INTERVENTION

Usual treatment

Interventions

PROMPT BEHAVIORAL

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.

Also known as: motor speech treatment

PROMPT Treated

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child between 2 and 9 years with a diagnosis of CP, with normal to mild intellectual disability and adequate language comprehension skills
• motor speech deficit

You may not qualify if:

• utilization of AAC strategies as the only means of communication,
• medical fragility or anatomical malformations affecting speech production preventing the ability to participate in the intervention

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead

Study Sites (1)

IRCCS Fondazione Stella Maris

Tirrenia, Tuscany, 56128, Italy

RECRUITING

Related Publications (26)

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• Reed A, Cummine J, Bakhtiari R, Fox CM, Boliek CA. Changes in White Matter Integrity following Intensive Voice Treatment (LSVT LOUD(R)) in Children with Cerebral Palsy and Motor Speech Disorders. Dev Neurosci. 2017;39(6):460-471. doi: 10.1159/000478724. Epub 2017 Jul 28.

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• Fiori S, Ragoni C, Podda I, Chilosi A, Amador C, Cipriani P, Guzzetta A, Sgandurra G. PROMPT to improve speech motor abilities in children with cerebral palsy: a wait-list control group trial protocol. BMC Neurol. 2022 Jul 6;22(1):246. doi: 10.1186/s12883-022-02771-6.

  PMID: 35794522 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Dysarthria

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simona Fiori, MD, PhD

  IRCCS Stella Maris Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Fiori, MD, PhD

CONTACT

00393288170636; s.fiori@fsm.unipi.it

Giuseppina Sgandurra, MD, PhD

CONTACT

0039050886310; g.sgandurra@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We plan a randomized trial using a wait-list control group.

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

IT (1)