The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy

NCT03264339 | Completed

• 1 other identifier: 2016/1366
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries which occur around birth. These children go through extensive treatment during childhood, but the treatment has generally been started late due to late diagnosis (median age 15 months). New recommendations state that the clinical diagnosis "high risk of CP" should be given before 6 months corrected age, in order to be able to intervene as early as possible, and have the best possibilities to prevent or limit the adverse neurodevelopmental consequences of brain injuries occurring around birth. Thus, there is a great need to develop evidence-based early interventions for children at high risk of developing cerebral palsy. The Small Step program is developed at Karolinska Institutet (KI) in Stockholm, Sweden and is based upon theories of brain plasticity induced by early learning. The efficacy of the program is presently being investigated at KI. Preliminary results indicate a large individual variation in response to the program among the participating children. The aim of the present study is therefore to explore individual responses to the Small Step Program in infants at risk of developing cerebral palsy. The main hypothesis is that infant characteristics, such as severity of brain pathology, are associated with differential response to the program. Also, infants with absent fidgety movements and children with sporadic fidgety movements are believed to respond differently to the program.

Conditions

Cerebral Palsy

Keywords

Infant; Hand/Growth & Development; Motor activity; Exercise; Communication

Outcome Measures

Primary Outcomes (1)

• Peabody Developmental Motor Scales, second edition (PDMS-2)

  PDMS-2 is a standard measurement that assesses gross and fine motor skills in young children from birth through age 5 years. The PDMS-2 is composed of six subtests that assess related motor abilities that develop early in life. In this study, the Stationary, Locomotion, Grasping, and Visual-Motor Integration subtests will be used. The scores on these subtests are presented as percentiles, standard scores, and age equivalents.

  up to 2 years

Secondary Outcomes (5)

• Hand Assessment for Infants (HAI)

  up to 2 years

• Alberta Infant Motor Scale (AIMS)

  up to 2 years

• Gross Motor Function Measure (GMFM-66)

  up to 2 years

• Parent-Child Early Relational Assessment (PC-ERA)

  up to 2 years

• Treatment Expectancy and Credibility Survey (TCS) - modification

  up to 2 years

Other Outcomes (10)

• Hammersmith Infant Neurological Examination (HINE)

  at baseline, after the intervention at 30 weeks and at follow-up up at 2 years

• The Working Model of the Child Interview (WMCI)

  at baseline, after the intervention at 30 weeks and at follow-up up at 2 years

• The Ages & Stages Questionnaire: Social and Emotional (ASQ:SE)

  at baseline, after the intervention at 30 weeks and at follow-up up at 2 years

Study Arms (1)

Smal step

EXPERIMENTAL

Small Step Program, comprising 3 treatment focus areas (Hand use, Mobility, Communication)

Behavioral: Small Step Program

Interventions

Small Step Program BEHAVIORAL

The Small Step intervention program has three alternating treatment foci (Hand use, Mobility, Communication) divided into five different steps, each lasting for 6 weeks (in total 30 weeks).

Smal step

Eligibility Criteria

• Age: 3 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• increased perinatal risk factors, such as preterm birth, hypoxic ischemic encephalopathy (asphyxia), and morphological brain abnormalities. These "at-risk" children are included in the regular clinical follow-up program at St. Olavs University Hospital comprising a standard examination at 3 months of age (for preterm born children: 3 months post term, so-called corrected age). At this examination, infants who exhibit two or more of the following additional risk factors will be eligible for study participation:
• Neurological signs assessed with Hammersmith Infant Neurological Examination (HINE) with a cut-off score of \< 57 (20).
• Delayed psycho-motor development measured with Alberta Infant Motor Scale (AIMS) using 2SD as the cut-off.
• Absent or sporadic fidgety movements assessed with the General Movements Assessment (GMA)
• Pathological findings on cerebral imaging (magnetic resonance imaging-MRI/cerebral ultrasound) done in regular clinical practice.

You may not qualify if:

• unstable medical condition
• progressive disorders
• diagnosis with a specific syndrome.
• neither parent is fluent in Norwegian or English. Satisfactory skills in either language are required for participation in data collection and the coaching and education program.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (3)

• 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 BACKGROUND

• Elvrum AG, Karstad SB, Hansen G, Bjorkoy IR, Lydersen S, Grunewaldt KH, Eliasson AC. The Small Step Early Intervention Program for Infants at High Risk of Cerebral Palsy: A Single-Subject Research Design Study. J Clin Med. 2024 Sep 6;13(17):5287. doi: 10.3390/jcm13175287.

  PMID: 39274500 DERIVED

• Karstad SB, Bjorseth A, Lindstedt J, Brenne AS, Steihaug H, Elvrum AG. Parental Coping, Representations, and Interactions with Their Infants at High Risk of Cerebral Palsy. J Clin Med. 2022 Dec 29;12(1):277. doi: 10.3390/jcm12010277.

  PMID: 36615077 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity; Communication

Condition Hierarchy (Ancestors)

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

Study Officials

• Elisabeth Selvaag, md

  St Olavs Hospital, Children's Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-subject research design (SSRD) will be used with each participant serving as his/her own control.

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 29, 2017
• Study Start: September 7, 2017
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)