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

NCT02166801 | Completed

• 1 other identifier: Smallstep
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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 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

Keywords

Cerebral palsy; Children; Early Intervention; Communication; Gross motor function; Hand function

Outcome Measures

Primary Outcomes (1)

• Peabody Developmental Motor Scales (PDMS-2) is used to measure change over time

  Assesses gross and fine motor skills in young children. It is designed to evaluate children from birth through age 5. The PDMS-2 is composed of six subtests that assess related motor abilities that develop early in life: Reflexes, Stationary (body control and equilibrium), Locomotion, Object Manipulation, Grasping, and Visual-Motor Integration. Results from these subtests are used to generate the three composite scores: Gross Motor Quotient, Fine Motor Quotient, and Total Motor Quotient. Scores are presented as percentiles, standard scores, and age equivalents. Norms, based on a nationally representative sample of more than 2,000 children, are stratified by age

  Small Step group: at baseline, 6w, 12w,18w, 24w, 30w and 2 years. In the usual care group: at baseline, 12 w, 30w and at 2 years.

Secondary Outcomes (13)

• Alberta Infant Motor Scale (AIMS) is used to measure change over time

  Small Step group: at baseline, 6w, 12w,18w, 24w, 30w and 2 years. In the usual care group: at baseline, 12 w, 30w and at 2 years.

• Hand Assessment for Infants, (HAI) is used to measure change over time

  Small Step group: at baseline, 6w, 12w,18w, 24w, 30w and 2 years. In the usual care group: at baseline, 12 w, 30w and at 2 years.

• Gross Motor Function Measure (GMFM-66) is used to measure change over time

  Small Step group: at baseline, 6w, 12w,18w, 24w, 30w and 2 years. In the usual care group: at baseline, 12 w, 30w and at 2 years.

• Hammersmith Infant Neurological Examination (HINE) is used to measure change over time

  Small Step group: at baseline, 6w, 12w,18w, 24w, 30w and 2 years. In the usual care group: at baseline, 12 w, 30w and at 2 years.

• Bayley Scales of Infant Development (BSID-III) is used to measure change over time

  Two occacions in both groups: 30w and 2 years.

Other Outcomes (2)

• Semi structured interview

  After interventionprogram, 30w, in the Small step group

• Structural magnetic resonance imaging (MRI)

  One time when the child is approximately 10-24 months

Study Arms (2)

Early intervention for infants

ACTIVE COMPARATOR

A 30w intensive intervention according to the small step program, with daily practice sections conducted by parents at home, with weekly support by therapists.

Behavioral: Early intervention for infants

Usual care

ACTIVE COMPARATOR

Usual care means that the Children in this arm of the study participate in the established follow up program that is established at the Astrid Lindgrens Children's Hospital and offered to all Children that displays a delayed early gross and fine motor development.

Behavioral: usual care

Interventions

Early intervention for infants BEHAVIORAL

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.

Early intervention for infants

usual care BEHAVIORAL

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.

Usual care

Eligibility Criteria

• Age: 4 Months - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• is unstable health, uncontrolled epilepsy, progressive disorder, diagnosis with a specific syndrome. Parent's communication language should be Swedish or English with satisfactory skills in either language for simple conversation. If the children show a catch-up in development at the second assessment (after 12 weeks) and show no sign of neurodevelopmental disorder the program will be terminated

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Astrid Lindgren Children Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Eliasson AC, Holmstrom L, Aarne P, Nakeva von Mentzer C, Weiland AL, Sjostrand L, Forssberg H, Tedroff K, Lowing K. Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical signs of CP; a study protocol. BMC Pediatr. 2016 Nov 3;16(1):175. doi: 10.1186/s12887-016-0711-x.

  PMID: 27809886 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Communication

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 18, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

SE (1)