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

Not Applicable

Completed

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

• Registration Number: NCT04259814
• Lead Sponsor: Shirley Ryan AbilityLab

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.

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 Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Primary Completion: 2020-05-26
• Study Completion: 2020-05-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Speech-Language Treatment plus mCIMT	Modified constraint-induced movement therapy (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.
Speech-Language Treatment plus mCIMT	Speech-language therapy (SLT)	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.

Primary Outcome Measures

Name	Time	Method
Probes	Up to 15 weeks	Number of trained words and phrases produced during a treatment session.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States