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

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT04259814
Collaborator
(none)
3
1
1
4.6
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Speech-language therapy (SLT)
  • Behavioral: Modified constraint-induced movement therapy (mCIMT)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Non-concurrent, multiple-baseline across participantsNon-concurrent, multiple-baseline across participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
Actual Study Start Date :
Jan 6, 2020
Actual Primary Completion Date :
May 26, 2020
Actual Study Completion Date :
May 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Speech-Language Treatment plus mCIMT

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.

Behavioral: Speech-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).

Behavioral: Modified 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.

Outcome Measures

Primary Outcome Measures

  1. Probes [Up to 15 weeks]

    Number of trained words and phrases produced during a treatment session.

Secondary Outcome Measures

  1. Mean Length of Utterance [Up to 15 weeks]

    Average length of utterances produced during treatment sessions

  2. Test of Early Language Development (TELD) [Up to 15 weeks]

    Standardized assessment of spoken language skills

  3. Goldman-Fristoe Test of Articulation-2 (GFTA-2) [Up to 15 weeks]

    Standardized assessment of production of sounds in words

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Months to 7 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Sudarshan Dayanidhi, PT, PhD, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sudarshan Dayanidhi, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT04259814
Other Study ID Numbers:
  • STU00211104
First Posted:
Feb 7, 2020
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sudarshan Dayanidhi, Principal Investigator, Shirley Ryan AbilityLab
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2021