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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Hemiplegia; Hemiparesis; Speech and Language Disorder
• Intervention / Treatment: Behavioral: Speech-language therapy (SLT); Behavioral: Modified constraint-induced movement therapy (mCIMT)

Detailed Description

Children with cerebral palsy (CP) often have hemiplegia, meaning only one side of the body is affected. They may have difficulty with daily tasks that require two hands. They may also have difficulty with speech and/or language. Constraint-induced movement therapy (CIMT) is a treatment that has been used to help improve children's performance of everyday activities and enhance their quality of life. CIMT uses a cast on the unaffected arm to encourage use of the affected hand. In traditional CIMT, a child wears a non-removable cast 24 hours a day for a duration of time. A more child-friendly version, modified constraint-induced movement therapy (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. Preliminary studies have also shown some speech and language improvement in children with speech impairments who participated in mCIMT.

The goal of this project is to investigate whether combining mCIMT with speech and language treatment (SPT) will enhance speech outcomes when compared with SPT alone. We will examine (1) whether it is feasible and effective to deliver (SPT) and mCIMT simultaneously, and (2) whether providing mCIMT simultaneously with SPT leads to greater gains in speech-language outcomes than SPT alone? Such information could add valuable evidence-based treatment options for children with hemiplegia and comorbid speech-language deficits, change the way in which we plan patients' care, and help justify co-treating patients who get mCIMT. We hypothesize that forced use of the impaired limb in therapeutic tasks would have spread effects resulting in increased rate of speech-language improvement during treatment intervals when the patient is casted.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Speech-Language Treatment plus mCIMT; 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); 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).; Behavioral: Modified constraint-induced movement therapy (mCIMT); Participants will wear a removable cast and an occupational therapist will be present during therapy to focus on facilitating play with the affected arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probes	Number of trained words and phrases produced during a treatment session.	Up to 15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Length of Utterance	Average length of utterances produced during treatment sessions	Up to 15 weeks
Test of Early Language Development (TELD)	Standardized assessment of spoken language skills	Up to 15 weeks
Goldman-Fristoe Test of Articulation-2 (GFTA-2)	Standardized assessment of production of sounds in words	Up to 15 weeks

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: Sudarshan Dayanidhi, PT, PhD, Shirley Ryan AbilityLab

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): May 26, 2020
• Study Completion (Actual): May 26, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: speech delay; one-sided weakness
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Communication Disorders; Paralysis; Cerebral Palsy; Hemiplegia; Paresis; Language Disorders
• Other Study ID Numbers: STU00211104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No