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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04259814
Enrollment
3
Registered
2020-02-07
Start date
2020-01-06
Completion date
2020-05-26
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech and Language Disorder, Cerebral Palsy, Hemiplegia, Hemiparesis

Keywords

speech delay, one-sided weakness

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.

Interventions

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).

BEHAVIORALModified 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.

Sponsors

Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Non-concurrent, multiple-baseline across participants

Eligibility

Sex/Gender
ALL
Age
15 Months to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ProbesUp to 15 weeksNumber of trained words and phrases produced during a treatment session.

Secondary

MeasureTime frameDescription
Mean Length of UtteranceUp to 15 weeksAverage length of utterances produced during treatment sessions
Test of Early Language Development (TELD)Up to 15 weeksStandardized assessment of spoken language skills
Goldman-Fristoe Test of Articulation-2 (GFTA-2)Up to 15 weeksStandardized assessment of production of sounds in words

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026