Clinical trial NCT04259814: Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
Official title: Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech and Language Disorder
Cerebral Palsy
Hemiplegia
Hemiparesis
Keywords: speech delay
one-sided weakness
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 3
Sex: ALL
Minimum age (years): 15
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-concurrent, multiple-baseline across participants
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Probes
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Mean Length of Utterance
timeFrame: Up to 15 weeks
measure: Test of Early Language Development (TELD)
timeFrame: Up to 15 weeks
measure: Goldman-Fristoe Test of Articulation-2 (GFTA-2)
timeFrame: Up to 15 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Sudarshan Dayanidhi, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1017/s0012162205000721.
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.
citation: 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.