Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
Primary Purpose
Speech and Language Disorder, Cerebral Palsy, Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech-language therapy (SLT)
Modified constraint-induced movement therapy (mCIMT)
Sponsored by
About this trial
This is an interventional treatment trial for Speech and Language Disorder focused on measuring speech delay, one-sided weakness
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.
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Speech-Language Treatment plus mCIMT
Arm 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.
Outcomes
Primary Outcome Measures
Probes
Number of trained words and phrases produced during a treatment session.
Secondary Outcome Measures
Mean Length of Utterance
Average length of utterances produced during treatment sessions
Test of Early Language Development (TELD)
Standardized assessment of spoken language skills
Goldman-Fristoe Test of Articulation-2 (GFTA-2)
Standardized assessment of production of sounds in words
Full Information
NCT ID
NCT04259814
First Posted
February 4, 2020
Last Updated
September 20, 2021
Sponsor
Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT04259814
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
May 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech and Language Disorder, Cerebral Palsy, Hemiplegia, Hemiparesis
Keywords
speech delay, one-sided weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-concurrent, multiple-baseline across participants
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speech-Language Treatment plus mCIMT
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Speech-language therapy (SLT)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Modified constraint-induced movement therapy (mCIMT)
Intervention Description
Participants will wear a removable cast and an occupational therapist will be present during therapy to focus on facilitating play with the affected arm.
Primary Outcome Measure Information:
Title
Probes
Description
Number of trained words and phrases produced during a treatment session.
Time Frame
Up to 15 weeks
Secondary Outcome Measure Information:
Title
Mean Length of Utterance
Description
Average length of utterances produced during treatment sessions
Time Frame
Up to 15 weeks
Title
Test of Early Language Development (TELD)
Description
Standardized assessment of spoken language skills
Time Frame
Up to 15 weeks
Title
Goldman-Fristoe Test of Articulation-2 (GFTA-2)
Description
Standardized assessment of production of sounds in words
Time Frame
Up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudarshan Dayanidhi, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15934484
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.
Results Reference
background
PubMed Identifier
21039439
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.
Results Reference
background
PubMed Identifier
28339405
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.
Results Reference
background
Learn more about this trial
Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
We'll reach out to this number within 24 hrs