Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02166801
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2014-06-12
Brief Title:
Small Step Intervention for Infants With Cerebral Palsy and Other Neurodevelopmental Disorders
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Small-step Program for Development of New Treatment Principles for Children With Cerebral Palsy and Other Neurodevelopmental Disorders
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
smallstep
Brief Summary:
Children with cerebral palsy CP have life-long motor disorders and are typically subjected to extensive treatment throughout childhood Despite this there is a lack of evidence supporting the effectiveness of treatment aiming at improving motor function and activity in daily life The primary area of interest of this research programme is to determine the effectiveness of an early intervention program in children younger than 12 months of age who are at risk of developing CP A randomised control trial is planned addressing hand use mobility and communication in a home-based program New treatment principles based on recent knowledge of brain plasticity will be employed
The overarching goal of this research programme is to develop and evaluate new intervention principles for children with neurodevelopmental disorders based upon theories of early learning induced brain plasticity Our overall aims can be formulated as follows
To evaluate the effects of an early intervention programme on the overall development in children with risk of developing cerebral palsy and other neurodevelopmental disorders The program includes intensive intervention towards the foci hand use mobility and communication in a home based program
The hypothesis is that the design of the Small-Step-Program intervention with clear foci on specific areas of development during different time periods and conducted in the childs home environment will facilitate development and be more effective than usual care
The second hypothesis is that children learn what they practice meaning that children will have a more rapid development within the focus of each specific step in the training when compared to the for the time being untrained steps
The third hypothesis is that childrens ability to learn within the different steps of the intervention programme will be influenced by the specific characteristics of any underlying brain pathology
The fourth hypothesis is that parents in the study group will be less stressed and can better cope with their childs situation than parents to children receiving usual care Thus the tools provided within the Small-Step-Program intervention like education supervision and feedback of how to practice communication and task performance will make parents more able to cope with the childs delayed development
The overarching goal of this research programme is to develop and evaluate new intervention principles for children with neurodevelopmental disorders based upon theories of early learning induced brain plasticity Our overall aims can be formulated as follows
To evaluate the effects of an early intervention programme on the overall development in children with risk of developing cerebral palsy and other neurodevelopmental disorders The program includes intensive intervention towards the foci hand use mobility and communication in a home based program
The hypothesis is that the design of the Small-Step-Program intervention with clear foci on specific areas of development during different time periods and conducted in the childs home environment will facilitate development and be more effective than usual care
The second hypothesis is that children learn what they practice meaning that children will have a more rapid development within the focus of each specific step in the training when compared to the for the time being untrained steps
The third hypothesis is that childrens ability to learn within the different steps of the intervention programme will be influenced by the specific characteristics of any underlying brain pathology
The fourth hypothesis is that parents in the study group will be less stressed and can better cope with their childs situation than parents to children receiving usual care Thus the tools provided within the Small-Step-Program intervention like education supervision and feedback of how to practice communication and task performance will make parents more able to cope with the childs delayed development
Detailed Description:
Rational for subject selection Signs of CP may be visible already during the first months but according to recommendations the diagnosis of CP should typically not be made until 2-4 years of age The reason is that the individual developmental trajectories of muscle tone postural control and motor function vary considerably during the first two years A child with a late development may recover and atypical signs may disappear and opposite CP may develop although there have been no early signs Thus there is a dilemma in that it is too late to wait with early intervention until the CP diagnosis has been made In this project we are addressing this problem by developing criteria for infants with high risk to develop CP based on early signs of atypical motor development and on perinatal risk factors That means that we will include both infants who will get and infants who will not get the CP diagnosis Children who are not meeting the criteria of CP at 2 years of age will be excluded from the analysis The investigators assume that the intervention will influence the course of development and help the children to function at a higher level but not that the intervention will cure CP and prevent later diagnosis Infants with increased risk to develop CP will be recruited in this project
The study group will be recruited from infants exposed to increased perinatal risk factors such as preterm birth hypoxia infections retinopathy of prematurity ROP chronic lung disease and heart insufficiency small for gestational age hypoxic ischemic insult and morphological brain abnormalities These children commonly participate in a clinical follow up programme at the childrens hospital with regular examinations at 3months The high-risk preterm infants that at follow up examinations exhibit a delayed psycho-motor development or display clinical signs of abnormal neurology will be recruited Recruitment will also include children below 8 months demonstrating delayed psycho-motor development or clinical signs of abnormal neurology referred to the physiotherapy department from child neurologists at the hospital
Randomisation The aim is to include 40 children in the study group with neurodevelopmental disorder to reach sufficient power in the study This number is high but the investigators expect that about 50 will not fulfil the diagnose criteria at 2 years of age based on previous experience from intervention studies The aim is to include 20 children with CP which is a reasonable approximation of study population size to reach sufficient power The children will be allocated to group by block randomisation The intervention group n20 will take part in a newly developed Small-Step-Program The comparison group n20 will continue their ordinary follow up programme Stratification will be used to control for gestational age preterm37 and term37 week Children in the Small-Step-Program will be further randomised to start with the mobility step or hand use step
Rational for second randomisation Our hypothesis is that the trained step will improve while the non-trained step will result in minor changes and that children in the control group will have a continuous developmental pace The randomised steps are hand use and mobility
The children in both groups will be assessed at four occasions at start first examination after 12 weeks second examination and after 30 weeks third examination as well as at 2 years of age fourth examination For children in the study group there will be 3 additional times for assessments in order to investigate the second hypothesis Parents in both groups will be asked to fill in questionnaires at all four examinations Both parents will be asked to fill out the questionnaires
The study group will be recruited from infants exposed to increased perinatal risk factors such as preterm birth hypoxia infections retinopathy of prematurity ROP chronic lung disease and heart insufficiency small for gestational age hypoxic ischemic insult and morphological brain abnormalities These children commonly participate in a clinical follow up programme at the childrens hospital with regular examinations at 3months The high-risk preterm infants that at follow up examinations exhibit a delayed psycho-motor development or display clinical signs of abnormal neurology will be recruited Recruitment will also include children below 8 months demonstrating delayed psycho-motor development or clinical signs of abnormal neurology referred to the physiotherapy department from child neurologists at the hospital
Randomisation The aim is to include 40 children in the study group with neurodevelopmental disorder to reach sufficient power in the study This number is high but the investigators expect that about 50 will not fulfil the diagnose criteria at 2 years of age based on previous experience from intervention studies The aim is to include 20 children with CP which is a reasonable approximation of study population size to reach sufficient power The children will be allocated to group by block randomisation The intervention group n20 will take part in a newly developed Small-Step-Program The comparison group n20 will continue their ordinary follow up programme Stratification will be used to control for gestational age preterm37 and term37 week Children in the Small-Step-Program will be further randomised to start with the mobility step or hand use step
Rational for second randomisation Our hypothesis is that the trained step will improve while the non-trained step will result in minor changes and that children in the control group will have a continuous developmental pace The randomised steps are hand use and mobility
The children in both groups will be assessed at four occasions at start first examination after 12 weeks second examination and after 30 weeks third examination as well as at 2 years of age fourth examination For children in the study group there will be 3 additional times for assessments in order to investigate the second hypothesis Parents in both groups will be asked to fill in questionnaires at all four examinations Both parents will be asked to fill out the questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None