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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259814
• Other study ID #: STU00211104
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: May 26, 2020

Study information

• Verified date: September 2021
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 26, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Months to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiparesis
• Hemiplegia
• Language Disorders
• Paresis
• Speech and Language Disorder

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probes	Number of trained words and phrases produced during a treatment session.	Up to 15 weeks
Secondary	Mean Length of Utterance	Average length of utterances produced during treatment sessions	Up to 15 weeks
Secondary	Test of Early Language Development (TELD)	Standardized assessment of spoken language skills	Up to 15 weeks
Secondary	Goldman-Fristoe Test of Articulation-2 (GFTA-2)	Standardized assessment of production of sounds in words	Up to 15 weeks