GO-PLAY - Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy

NCT05883969 | Recruiting DMC

• 1 other identifier: H-22041835
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Background. Early diagnosis of cerebral palsy (CP) is important to enable appropriate intervention at a time when neuroplasticity is at its highest. Early intervention with focus on family-centered, home-based, parent-involved, and supervised by specialist therapists show positive cognitive and motor outcomes. This study adhere to international guidelines for early diagnosis and intervention, and include community therapists to ensure regular follow-up during and after the intervention period. The aim of the current study is to compare the effectiveness of an early intervention program added to standard care, relative to standard care alone, on the early motor development in children from both a newborn and infant detectable risk pathway in a Danish multi-site setting. Methods. In a randomized, controlled trial the response to the GO-PLAY (Goal Oriented ParentaL supported home ActivitY) intervention program added to standard care is superior to standard care alone is evaluated. The investigators will include infants from the Cerebral Palsy - Early Diagnosis and Intervention Trial (CP-EDIT registered separately at ClinicalTrials) and collect data at baseline, after intervention and at follow up when the children are 2 years corrected age. The hypotheses are that the GO-PLAY intervention is more effective than standard care when the children are re-evaluated at the end of 6 months of intervention and that the parents involved in the GO-PLAY intervention will exhibit less signs of stress and anxiety and perceive the services that they are receiving as family-centered to a greater extent than parents of children receiving standard care. Discussion. Approximately half of all infants with high risk of CP display high risk indicators identifiable by early screening before 5 months of age described as the newborn detectable risk pathway. The other half of all infants with CP are detected by parents, caregivers or health care professionals when displaying delayed motor milestones (e.g. hand asymmetry or not sitting at 9 months) and described as infant detectable risk pathway. There is a need to investigate if early intervention is effective in all infants with high suspicion of CP, also the ones with unremarkable neonatal history. Further, a systematic early intervention has not been tested in infants at high risk of CP in Denmark, where public health services include physiotherapy free of charge for infants with CP.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Peabody Developmental Motor Scales - Second edition (PDMS-2)

  PDMS-2 is a standardized, norm-referenced measure used to evaluate the gross and fine motor development of children aged birth to 6 years. The gross motor component is comprised of four subtests: reflexes (raw score range 0-16), stationary (raw score range 0-60), locomotion (raw score range 0-178) and object manipulation (raw score range 0-48). Two subtests, grasping (raw score range 0-52) and visual-motor integration (raw score range 0-144), form the fine motor component. The total Motor Quotient (TMQ) is formed by a combination of the results of the gross and fine motor subtests. The PDMS-2 TMQ range from 90-165 (indicating average or above average age-normed motor abilities) to 89-35 (indicating below average to very poor age-normed motor abilities).

  Change from baseline at 6 months

Secondary Outcomes (6)

• Alberta Infant Motor Scale (AIMS)

  Change from baseline at 6 months

• Gross Motor Function Measure (GMFM-66)

  Change from baseline at 6 months (if > 5 months at inclusion)

• Hand Assessment in Infants (HAI)

  Change from baseline at 6 months (if<12 months)

• The Parental Stress scale (PSS)

  Change from baseline at 6 months

• The Depression Anxiety Stress Scales (DASS-21)

  Change from baseline at 6 months

Other Outcomes (9)

• Peabody Developmental Motor Scales - Second edition (PDMS-2)

  at 24 months corrected age

• Gross Motor Function Measure (GMFM-66)

  at 24 months corrected age

• Bayley Scales of Infant and Toddler Development 4 (BSID-4) -cognitive

  at 24 months corrected age

Study Arms (2)

Early intervention for infants

ACTIVE COMPARATOR

Early family-centered, individualized, goal-directed, intensive, and carried out within the home environment in a cross sectorial setting fortnightly contact shifting between at home visits and virtual meetings for 6 months after an interim diagnosis of CP or high risk of CP

Behavioral: GO-PLAY

Usual care

OTHER

Standard care consists rehabilitation offered by the local hospital/community or other private initiatives when diagnosed with CP or high risk of CP. The approach, frequency, and location (at home or rehabilitation centers) is varied

Behavioral: Usual care

Interventions

GO-PLAY BEHAVIORAL

The intervention is family-centered, individualized, goal-directed, intensive, and carried out within the home environment. The GO-PLAY intervention will last for six months and consists of a home visit once a month and a virtual meeting by telephone or video once a month. The intervention will be family centered. Experienced physiotherapists and occupational therapists will be the primary therapists providing the intervention to ensure uniformity. The motor learning element of the intervention is based on the principles of motor learning and dynamic systems theory. Emphasis is on children's self-initiated actions, which are stimulated by meaningful and motivating activities and toys. The child's play preferences to elicit self-generated motor activity will be the underlying basis of the training. Minimal manual guidance is provided when needed and withdrawn when the child demonstrates self-generated ability to complete part of the task.

Early intervention for infants

Usual care BEHAVIORAL

Children will receive referral for rehabilitation in the municipality as usual. Standard care consists of the additional follow up assessments in CP-EDIT as well as rehabilitation offered by their local hospital/community or other private initiatives when diagnosed with CP or high risk of CP. The approach, frequency, and location (at home or rehabilitation centers) is varied according to the center's protocol and not possible to standardize.

Usual care

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants will be included in the intervention study, if they fulfil at least one of the requirements A or B:
• A. any two of the following:
• Neuroimaging predictive of a motor disability including the involvement of one or more of the following structures: sensori-motor cortex, basal ganglia, posterior limb of the internal capsule, pyramidal tracts.
• General Movement Assessment with absent fidgety GMs at fidgety age
• HINE scores \<57 at 3months or \<60 at 6months or \<63 at 9 months or \<66 at 12 months
• B. both of the following:
• Unilateral brain injury on neuroimaging (MRI or ultrasound) predictive of CP
• Clinical signs of asymmetry

You may not qualify if:

• Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
• Infants with other disability diagnoses e.g. Down Syndrome.
• children for whom neither parent is fluent in Danish.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina Hoi-Hansen, Professor

  Department of Paediatrics, University Hospital Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Mette Johansen

CONTACT

+4530473915; m.johansen1@rn.dk

Gija Rackauskaite, MD, PhD

CONTACT

gija.rackauskaite@auh.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: June 1, 2023
• Study Start: April 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

DK (2)