ClinicalTrials.Veeva

Menu

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

Shirley Ryan AbilityLab logo

Shirley Ryan AbilityLab

Status

Completed

Conditions

Cerebral Palsy
Speech and Language Disorder
Hemiparesis
Hemiplegia

Treatments

Behavioral: Modified constraint-induced movement therapy (mCIMT)
Behavioral: Speech-language therapy (SLT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04259814
STU00211104

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

15 months to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Speech-Language Treatment plus mCIMT
Experimental group
Description:
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.
Treatment:
Behavioral: Modified constraint-induced movement therapy (mCIMT)
Behavioral: Speech-language therapy (SLT)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems