Clinical Trials Directory

Trials / Completed

CompletedNCT04259814

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Shirley Ryan AbilityLab · Academic / Other
Sex
All
Age
15 Months – 7 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSpeech-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).
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.

Timeline

Start date
2020-01-06
Primary completion
2020-05-26
Completion
2020-05-26
First posted
2020-02-07
Last updated
2021-09-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04259814. Inclusion in this directory is not an endorsement.