Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis

NCT04259814 | Completed

• 1 other identifier: STU00211104
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Modified constraint-induced movement therapy (mCIMT) has been successfully used with children who have hemiplegia (weakness or paralysis on one side of the body.) mCIMT uses a removable cast during treatment and home exercise programs. It has been found that mCIMT can improve use, strength and coordination of a child's affected hand, and may also help improve speech and language skills. The goal of this project is to investigate whether combining mCIMT with speech therapy will enhance speech outcomes in children with cerebral palsy.

Conditions

Speech and Language Disorder; Cerebral Palsy; Hemiplegia; Hemiparesis

Keywords

speech delay; one-sided weakness

Outcome Measures

Primary Outcomes (1)

• Probes

  Number of trained words and phrases produced during a treatment session.

  Up to 15 weeks

Secondary Outcomes (3)

• Mean Length of Utterance

  Up to 15 weeks

• Test of Early Language Development (TELD)

  Up to 15 weeks

• Goldman-Fristoe Test of Articulation-2 (GFTA-2)

  Up to 15 weeks

Study Arms (1)

Speech-Language Treatment plus mCIMT

EXPERIMENTAL

4 participants Baseline phase: Speech-language treatment (SLT), 1 hour a day, 3 days a week. The length of the baseline phase will be staggered across subjects. Treatment phase: SLT combined with modified constraint-induced movement therapy(mCIMT) 1 hour a day, 3 days a week. Total of baseline and treatment sessions will be 20 to 30 sessions.

Behavioral: Speech-language therapy (SLT); Behavioral: Modified constraint-induced movement therapy (mCIMT)

Interventions

Speech-language therapy (SLT) BEHAVIORAL

Age-appropriate play activities with speech-language pathologist (SLP) to elicit speech, using stimulation strategies including but not limited to recasts, expansion, parallel talk, interactive modeling, communication temptations, and phrase completions. Activities will include an age-appropriate story, pretend play (i.e., house with people, playing with a baby doll), an assembly task (i.e., building blocks, making pretend pizza), and a highly motivating, clinician-controlled activity (i.e., blowing bubbles, swing, pushing cars down a ramp).

Speech-Language Treatment plus mCIMT

Modified constraint-induced movement therapy (mCIMT) BEHAVIORAL

Participants will wear a removable cast and an occupational therapist will be present during therapy to focus on facilitating play with the affected arm.

Speech-Language Treatment plus mCIMT

Eligibility Criteria

• Age: 15 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Previous diagnosis of Cerebral Palsy
• Hemiplegia
• Speech-Language Impairment
• English as primary language spoken in the patient's home
• Normal or corrected hearing and vision

You may not qualify if:

• Presence of co-morbid developmental disability (not including specific language impairment) which has an impact on cognition, sensory processing, and/or social-pragmatic function
• Non-corrected hearing loss as evidenced by audiology report, failure to pass a newborn hearing screening, and/or performance on pure-tone testing.
• Non-corrected vision impairments
• Weakness on both sides or neither side of the body
• Bilingual speakers or patients who speak languages other than English
• Previous history of CIMT or mCIMT within the past 6 months.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Naylor CE, Bower E. Modified constraint-induced movement therapy for young children with hemiplegic cerebral palsy: a pilot study. Dev Med Child Neurol. 2005 Jun;47(6):365-9. doi: 10.1017/s0012162205000721.

  PMID: 15934484 BACKGROUND

• Sigurdardottir S, Vik T. Speech, expressive language, and verbal cognition of preschool children with cerebral palsy in Iceland. Dev Med Child Neurol. 2011 Jan;53(1):74-80. doi: 10.1111/j.1469-8749.2010.03790.x. Epub 2010 Oct 11.

  PMID: 21039439 BACKGROUND

• Allison KM, Reidy TG, Boyle M, Naber E, Carney J, Pidcock FS. Speech production gains following constraint-induced movement therapy in children with hemiparesis. J Pediatr Rehabil Med. 2017;10(1):3-9. doi: 10.3233/PRM-170405.

  PMID: 28339405 BACKGROUND

MeSH Terms

Conditions

Speech; Language Disorders; Cerebral Palsy; Hemiplegia; Paresis; Language Development Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Paralysis

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Sudarshan Dayanidhi, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-concurrent, multiple-baseline across participants

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 7, 2020
• Study Start: January 6, 2020
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)