Cerebral PalsyB-CIMTNCT01864811
Effect of Baby-CIMT in Infants Younger Than 12 Months
A study testing Baby-CIMT and Baby-Massage in people with Cerebral Palsy and Hemiplegia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A randomized control trial investigating if an early intervention program of modified Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age will improve hand function in children with risk for developing cerebral palsy. Read more about this study
- Who is it for?
- Ages 3 to 8 months
- Conditions the study is for
- Cerebral Palsy, Hemiplegia, Children
- What is being tested?
- Baby-CIMT and Baby-Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to 1 Dec 2017
- 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 3 to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Severe visual impairment Seizures not controlled by drugs Not unilateral CP at 12 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Constraint Induced Movement Therapy for Babies (Baby-CIMT) in Infants Below 12 Month With Risk of Developing Unilateral Cerebral Palsy, a Study Protocol of a Randomized Controlled Trial
A randomized control trial investigating if an early intervention program of modified Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age will improve hand function in children with risk for developing cerebral palsy.
Read the detailed description
The investigators hypothesis is that Baby-CIMT including intensive specific task oriented training is more preferable than general stimulation which is the assumption for baby massage used in the control group. The intervention protocol is developed at Astrid Lindgren Children hospital, Stockholm Sweden.
- Conditions
- Cerebral Palsy, Hemiplegia, Children
- Being tested
- Baby-CIMT, Baby-Massage
- Keywords
- infants, unilateral cerebral pares, hand function, early intervention, constraint induced movement therapy
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-CIMTBehavioural
Also called Constraint Induced Movement therapy
Baby-CIMT is a very much modified model of constraint induced movement therapy for infants. It is developed to suit small children and their needs of stimulation. The infant should wear a comfortable glove on the less affected hand, while stimulating the use of the affected hand 30 minutes per day during 2 periods of 6-weeks training before 12 month. The hand training provides the baby with amusing and easily handled toys.
Baby-MassageBehavioural
For baby massage, there will be a special instructional course by a health professional certified for baby massage. Massage should be given every day during 2 periods of 6 weeks. Families will be responsible for the massage.
| Study group | Role | What they receive |
|---|---|---|
| Baby-CIMT | Experimental | The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys. Receives: Behavioral: Baby-CIMT |
| baby-massage | Experimental | The infants will receive baby massage Receives: Behavioral: Baby-Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Assessment for Infants (HAI)
Hand Assessment for Infants (HAI) identify and measure upper limb asymmetry and general manual development from 3-12 month in children at risk of developing cerebral palsy.Even though our Primary Outcome Measure is when children are at one year post term age, we are going to publish results from assessments at earlier ages to measure changes after each intervention period.
Measured: 12 month post term age
Secondary outcomes (1)
Alberta Motor Infant Scale
Identification of infants who are delayed or deviant in motor development and evaluation of motor development over time. Identifies gross motor performance of an infant compared to norm- referenced sample.
Measured: Baseline and12 months post term age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startSep 2012
- Primary completion1 Dec 2015
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann-Christin Eliasson, Karolinska Institutet
- Investigators
- Ann-Christin Eliasson, professor, Principal investigator, Department of Women's and Children's Health, Karolinska Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864811
- Sponsor's protocol ID
- SFO-V4072/2012
- Other IDs
- 2011-1522-81929-42
- Acronym
- B-CIMT
- Status last verified
- Aug 2018
- First submitted
- 22 May 2013
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Greaves S, Imms C, Krumlinde-Sundholm L, Dodd K, Eliasson AC. Bimanual behaviours in children aged 8-18 months: a literature review to select toys that elicit the use of two hands. Res Dev Disabil. 2012 Jan-Feb;33(1):240-50. doi: 10.1016/j.ridd.2011.09.012. Epub 2011 Oct 11.
PubMed 22093670
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Constraint Induced Movement Therapy for Babies (Baby-CIMT) in Infants Below 12 Month With Risk of Developing Unilateral Cerebral Palsy, a Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01864811
- Acronym / sponsor ID
- B-CIMT / SFO-V4072/2012
- Conditions
- Cerebral Palsy, Hemiplegia, Children
- Keywords
- infants, unilateral cerebral pares, hand function, early intervention, constraint induced movement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 30 May 2013 (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.
A randomized control trial investigating if an early intervention program of modified Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age will improve hand function in children with risk for developing cerebral palsy.
Detailed description
The investigators hypothesis is that Baby-CIMT including intensive specific task oriented training is more preferable than general stimulation which is the assumption for baby massage used in the control group. The intervention protocol is developed at Astrid Lindgren Children hospital, Stockholm Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby-CIMT | Experimental | Behavioral: Baby-CIMTThe infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys. |
| baby-massage | Experimental | Behavioral: Baby-MassageThe infants will receive baby massage |
Who may qualify
- Ages
- 3 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Severe visual impairment Seizures not controlled by drugs Not unilateral CP at 12 month
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 |
|---|---|---|
| Baby-CIMTAlso: Constraint Induced Movement therapyBaby-CIMT is a very much modified model of constraint induced movement therapy for infants. It is developed to suit small children and their needs of stimulation. The infant should wear a comfortable glove on the less affected hand, while stimulating the use of the affected hand 30 minutes per day during 2 periods of 6-weeks training before 12 month. The hand training provides the baby with amusing and easily handled toys. | Behavioural | Baby-CIMT |
| Baby-MassageFor baby massage, there will be a special instructional course by a health professional certified for baby massage. Massage should be given every day during 2 periods of 6 weeks. Families will be responsible for the massage. | Behavioural | baby-massage |
Primary outcome
Hand Assessment for Infants (HAI)
Time frame: 12 month post term age
Hand Assessment for Infants (HAI) identify and measure upper limb asymmetry and general manual development from 3-12 month in children at risk of developing cerebral palsy.Even though our Primary Outcome Measure is when children are at one year post term age, we are going to publish results from assessments at earlier ages to measure changes after each intervention period.
1 secondary outcome
Alberta Motor Infant Scale
Time frame: Baseline and12 months post term age
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 Aug 2018.
- Background: PubMed 22093670Greaves S, Imms C, Krumlinde-Sundholm L, Dodd K, Eliasson AC. Bimanual behaviours in children aged 8-18 months: a literature review to select toys that elicit the use of two hands. Res Dev Disabil. 2012 Jan-Feb;33(1):240-50. doi: 10.1016/j.ridd.2011.09.012. Epub 2011 Oct 11.
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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.
Ann-Christin Eliasson, professor principal investigator
Department of Women's and Children's Health, Karolinska Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-CIMT and Baby-Massage in people with Cerebral Palsy and Hemiplegia, run by Karolinska Institutet at 1 site in Sweden.
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 0 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 Aug 2018. 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 Sweden. 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?
Hand Assessment for Infants (HAI) (time frame: 12 month post term age). 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 NCT01864811, which also lists 1 linked publication.
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 Aug 2018.