StrokeNCT02720432
Early Intervention in Infants With Perinatal Stroke
A study testing CIMT, HABIT and baby-massage in people with Stroke, run by University Ghent at 1 site in Belgium.
Trial summary
This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP. Read more about this study
- Who is it for?
- Ages 4 to 8 months
- Conditions the study is for
- Stroke
- What is being tested?
- CIMT, HABIT and baby-massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jun 2016to Mar 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 4 to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a perinatal stroke confirmed on neonatal imaging and from who the parents speaks Dutch and live in Belgium, will be included in the study. Only infants showing abnormal 'general movements' between 10 and 15 weeks will be eligible for the intervention part.
Who cannot join
- Infants with severe genetic abnormalities or malformations, with severe visual impairments or with uncontrolled seizures will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial
This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.
Read the detailed description
Perinatal stroke constitutes an acute presentation of encephalopathy; manifesting as seizure, altered mental status, and/or neurological deficit; between birth and the twenty-eight postnatal day for which a pattern of ischemic brain injury in an arterial distribution is evident by neuroimaging. Following perinatal stroke, approximately 60% of children develop cerebral palsy (usually presenting as spastic hemiplegia), 30-60% experience epilepsy, 25% show language delay, and up to 22% manifest behavioral problems.
The current most predictive tools for early diagnosis of CP are a combination of brain MRI/cUS and a general movements (GM) assessment in the fidgety period (9). Asymmetry of fidgety GMs around 12 weeks post term can be the first clinical signs of hemiplegia.
There are currently two intensive therapy approaches aiming at improving upper limb performance in adults and children (average age 8 years) with established hemiplegic CP: constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT). Those current therapy approaches fundamentally comprise repeated practice of desired movements based on motor learning principles with the adult/ child as an active participant.
Both therapies, in adults and in children with established hemiplegic CP (average age 8 years) are effective and show similar improvements if the dosage of therapy is similar. In contrast, the feasibility and the effects of both therapy approaches at very young age (under age 1 year) is still unknown (22). Exploring these options to treat even before asymmetric hand use has appeared is interesting and promising enough since recent animal studies have demonstrated that there is a critical period of motor system plasticity, and that activity-dependent reorganization of the motor-projection pattern to the hand occurs before about 1 year of age
- Conditions
- Stroke
- Being tested
- CIMT, HABIT, baby-massage
- Keywords
- early intervention, infant
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMTOther
Constraint-induced movement therapy
HABITOther
hand-arm bimanual intensive training
baby-massageOther
instructions for baby-massage
| Study group | Role | What they receive |
|---|---|---|
| CIMT | Experimental | A soft splint or restraint will be posed to best functioning hand of the infant only during the therapy session. Parents will be educated to perform the therapy, which consists of stimulation of reaching and grasping with the hemiplegic arm.
The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform CIMTfor 30 minutes, 6 days a week. Receives: Other: CIMT |
| HABIT | Experimental | No restraint will be implemented and instead of promoting unilateral grasping, bimanual grasping will be stimulated. Toys will be precisely selected to stimulate progressed bimanual grasping. The approach of the therapist and parents remain equal.
The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform HABIT for 30 minutes, 6 days a week. Receives: Other: HABIT |
| Baby-massage | Sham comparator | 3 sessions of baby-massage will be given by a qualified instructor Receives: Other: baby-massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of the Hand assessment for infants (HAI)
The HAI is the very new assessment tool to evaluate the hand function and asymmetry in infants age from 2 till 8 months post term.
Measured: before (around 4 months) and after 18 weeks of intervention (around 9 months)
Change in the score of the Infant motor profile
The IMP is a video-based assessment to evaluate the spontaneous motor behavior of infants from 3 months till independent walking around 18 months of age
Measured: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Change in the score of the Alberta infant motor scale
The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.
Measured: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Secondary outcomes (3)
Bayley scales for infant development-third edition
The Bayley Scales of Infant and Toddler Development, Third is a validated and extensively used developmental scale for assessing the cognitive, language and motor development from 1 month till 42 months of age.
Measured: between 22 and 24 months (2 years)
Parental sense of competence scale
The parenting Sense of Competence scale is a 16-item Likert-scale questionnaire to measure parent's sense of confidence and satisfaction.
Measured: before intervention (around 4months)
Questionnaire satisfaction and impact
A questionnaire will be filled out by the parents at the end of the therapy. They will be asked about the satisfaction of the therapy and therapist.
Measured: after the intervention (around 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start29 Jun 2016
- Primary completionMar 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Govaert, Dr, Principal investigator, Universiteit Gent, vakgroep REVAKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720432
- Sponsor's protocol ID
- 2015/1299
- Status last verified
- Dec 2021
- First submitted
- 2 Mar 2016
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02720432
- Acronym / sponsor ID
- 2015/1299
- Conditions
- Stroke
- Keywords
- early intervention, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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.
This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.
Detailed description
Perinatal stroke constitutes an acute presentation of encephalopathy; manifesting as seizure, altered mental status, and/or neurological deficit; between birth and the twenty-eight postnatal day for which a pattern of ischemic brain injury in an arterial distribution is evident by neuroimaging. Following perinatal stroke, approximately 60% of children develop cerebral palsy (usually presenting as spastic hemiplegia), 30-60% experience epilepsy, 25% show language delay, and up to 22% manifest behavioral problems.
The current most predictive tools for early diagnosis of CP are a combination of brain MRI/cUS and a general movements (GM) assessment in the fidgety period (9). Asymmetry of fidgety GMs around 12 weeks post term can be the first clinical signs of hemiplegia.
There are currently two intensive therapy approaches aiming at improving upper limb performance in adults and children (average age 8 years) with established hemiplegic CP: constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT). Those current therapy approaches fundamentally comprise repeated practice of desired movements based on motor learning principles with the adult/ child as an active participant.
Both therapies, in adults and in children with established hemiplegic CP (average age 8 years) are effective and show similar improvements if the dosage of therapy is similar. In contrast, the feasibility and the effects of both therapy approaches at very young age (under age 1 year) is still unknown (22). Exploring these options to treat even before asymmetric hand use has appeared is interesting and promising enough since recent animal studies have demonstrated that there is a critical period of motor system plasticity, and that activity-dependent reorganization of the motor-projection pattern to the hand occurs before about 1 year of age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CIMT | Experimental | Other: CIMTA soft splint or restraint will be posed to best functioning hand of the infant only during the therapy session. Parents will be educated to perform the therapy, which consists of stimulation of reaching and grasping with the hemiplegic arm. The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform CIMTfor 30 minutes, 6 days a week. |
| HABIT | Experimental | Other: HABITNo restraint will be implemented and instead of promoting unilateral grasping, bimanual grasping will be stimulated. Toys will be precisely selected to stimulate progressed bimanual grasping. The approach of the therapist and parents remain equal. The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform HABIT for 30 minutes, 6 days a week. |
| Baby-massage | Sham comparator | Other: baby-massage3 sessions of baby-massage will be given by a qualified instructor |
Who may qualify
- Ages
- 4 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with a perinatal stroke confirmed on neonatal imaging and from who the parents speaks Dutch and live in Belgium, will be included in the study. Only infants showing abnormal 'general movements' between 10 and 15 weeks will be eligible for the intervention part.
Key exclusion criteria (1 listed)
- Infants with severe genetic abnormalities or malformations, with severe visual impairments or with uncontrolled seizures will be excluded.
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 |
|---|---|---|
| CIMTConstraint-induced movement therapy | Other | CIMT |
| HABIThand-arm bimanual intensive training | Other | HABIT |
| baby-massageinstructions for baby-massage | Other | Baby-massage |
Primary outcome
Change in the score of the Hand assessment for infants (HAI)
Time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months)
The HAI is the very new assessment tool to evaluate the hand function and asymmetry in infants age from 2 till 8 months post term.
Change in the score of the Infant motor profile
Time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
The IMP is a video-based assessment to evaluate the spontaneous motor behavior of infants from 3 months till independent walking around 18 months of age
Change in the score of the Alberta infant motor scale
Time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.
3 secondary outcomes
Bayley scales for infant development-third edition
Time frame: between 22 and 24 months (2 years)
Parental sense of competence scale
Time frame: before intervention (around 4months)
Questionnaire satisfaction and impact
Time frame: after the intervention (around 9 months)
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 10 Dec 2021.
- 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.
Paul Govaert, Dr principal investigator
Universiteit Gent, vakgroep REVAKI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIMT, HABIT and baby-massage in people with Stroke, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 1 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 10 Dec 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Change in the score of the Hand assessment for infants (HAI) (time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2021.