Speech and Language DisorderNCT04259814
Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
A study testing Speech-language therapy (SLT) and Modified constraint-induced movement therapy (mCIMT) in people with Speech and Language Disorder and Cerebral Palsy, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 months to 7 years
- Conditions the study is for
- Speech and Language Disorder, Cerebral Palsy, Hemiplegia
- What is being tested?
- Speech-language therapy (SLT) and Modified constraint-induced movement therapy (mCIMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 26 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Speech and Language Disorder, Cerebral Palsy, Hemiplegia, Hemiparesis
- Being tested
- Speech-language therapy (SLT), Modified constraint-induced movement therapy (mCIMT)
- Keywords
- speech delay, one-sided weakness
- Medical subject headings
- Speech, Language Disorders, Cerebral Palsy, Hemiplegia, Paresis, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech-language therapy (SLT)Behavioural
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).
Modified constraint-induced movement therapy (mCIMT)Behavioural
Participants will wear a removable cast and an occupational therapist will be present during therapy to focus on facilitating play with the affected arm.
| Study group | Role | What they receive |
|---|---|---|
| Speech-Language Treatment plus mCIMT | Experimental | 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. Receives: Behavioral: Speech-language therapy (SLT); Behavioral: Modified constraint-induced movement therapy (mCIMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probes
Number of trained words and phrases produced during a treatment session.
Measured: Up to 15 weeks
Secondary outcomes (3)
Mean Length of Utterance
Average length of utterances produced during treatment sessions
Measured: Up to 15 weeks
Test of Early Language Development (TELD)
Standardized assessment of spoken language skills
Measured: Up to 15 weeks
Goldman-Fristoe Test of Articulation-2 (GFTA-2)
Standardized assessment of production of sounds in words
Measured: Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start6 Jan 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Speech and Language DisorderStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-concurrent, multiple-baseline across participants
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudarshan Dayanidhi, Shirley Ryan AbilityLab
- Investigators
- Sudarshan Dayanidhi, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259814
- Sponsor's protocol ID
- STU00211104
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15934484Sigurdardottir 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.
PubMed 21039439Allison 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.
PubMed 28339405
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of mCIMT Casting on Speech-language Outcomes in Children With Hemiparesis
- ClinicalTrials.gov ID
- NCT04259814
- Acronym / sponsor ID
- STU00211104
- Conditions
- Speech and Language Disorder, Cerebral Palsy, Hemiplegia, Hemiparesis
- Keywords
- speech delay, one-sided weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-concurrent, multiple-baseline across participants
| Arm | Type | Receives |
|---|---|---|
| Speech-Language Treatment plus mCIMT | Experimental | Behavioral: Speech-language therapy (SLT), Behavioral: Modified constraint-induced movement therapy (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. |
Who may qualify
- Ages
- 15 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Speech-Language Treatment plus mCIMT |
| 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. | Behavioural | Speech-Language Treatment plus mCIMT |
Primary outcome
Probes
Time frame: Up to 15 weeks
Number of trained words and phrases produced during a treatment session.
3 secondary outcomes
Mean Length of Utterance
Time frame: Up to 15 weeks
Test of Early Language Development (TELD)
Time frame: Up to 15 weeks
Goldman-Fristoe Test of Articulation-2 (GFTA-2)
Time frame: Up to 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Background: PubMed 15934484Naylor 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.
- Background: PubMed 21039439Sigurdardottir 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.
- Background: PubMed 28339405Allison 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudarshan Dayanidhi, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech-language therapy (SLT) and Modified constraint-induced movement therapy (mCIMT) in people with Speech and Language Disorder and Cerebral Palsy, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probes (time frame: Up to 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259814, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.