Small Step Intervention for Infants With Cerebral Palsy and Other Neurodevelopmental Disorders

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 child's 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 children's 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 child's 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 child's delayed development.

Conditions

• Gross Motor Development Delay
• Cerebral Palsy

Interventions

BEHAVIORAL

Early intervention for infants

Three foci are included in the intervention: Communication, Hand function and Mobility/gross motor function. The Hand \& Cognition and Mobility steps will be conducted during two time-periods. Communication will have a separate one-time intervention at the start of the study (prior to step I) in addition to one intervention period during step III (figure 1). General principles for the small step program: Training will be conducted in the children's home by the parents on a daily basis. The families will get instructions and supervision in their home every week by the therapist responsible for each specific step of the intervention. For each focus there will be different steps using an adaptive logarithm for training, i.e., adapted to the functional level of the child aiming at the next small developmental step. The family will be actively involved in identifying new foci for practice.

BEHAVIORAL

usual care

Children displaying delayed development and at risk of developing cerebral palsy are continuously followed-up at the children's hospital. There are no strict rules for the frequency of appointments within the usual care program but the families typically meet a physiotherapist every third week during the first 2-3 months, thereafter about once a month. The frequency depends on the family's needs and wishes. If there is a continuous need for therapeutic intervention and need of contact with different professions, the families will be referred to the Habilitation Services when the child is between 8-12 months. The control group will follow this customary procedure in the hospital. The only difference will be the assessment procedure, the sessions with the speech pathologist and that they will get feedback of the children's progress after each examination.

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• Karolinska Institutet

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Months

Max Age

10 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Sweden

Study Locations