Cerebral PalsyGO-PLAYNCT05883969
GO-PLAY - Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy
A study testing GO-PLAY in people with Cerebral Palsy, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- GO-PLAY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Apr 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants will be included in the intervention study, if they fulfil at least one of the requirements A or B:
- 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
- both of the following:
- Unilateral brain injury on neuroimaging (MRI or ultrasound) predictive of CP
- Clinical signs of asymmetry
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gija Rackauskaite, MD, PhD contact
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Mette Johansen, +4530473915, m.johansen1@rn.dk
Gija Rackauskaite, gija.rackauskaite@auh.rm.dk
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Gija Rackauskaite, gija.rackauskaite@auh.rm.dk
Mette Johansen, +4530473915, m.johansen1@rn.dk
About this study
Official title: Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy: Protocol for the Randomized Controlled GO-PLAY Trial
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.
Read more
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.
Read the detailed description
Signs of CP may be visible already at three months of age but the mean diagnostic age is 13 months in Denmark. An early diagnosis is important in order to start relevant intervention when neuroplasticity is highest.
The study group will be recruited from the CP-EDIT, where both the newborn- and infant-detectable risk pathway from 3-12 months corrected age are included. Neonates may have obvious risk factors in the neonatal period, but in the present study infants with clinical findings suggesting CP emerging in the first year of life are also included. An interim diagnosis based on recommended predictive tools for early diagnosis; cerebral MRI, the General Movement Assessment (if < 5 months) and the Hammersmith Infant Neurological Examination will be an inclusion criteria for this study. In addition the Hand Assessment for Infants will be included to assess early hand asymmetry.
An estimated sample size of 60 participants in total; approximately 30 per group is expected. The infants will be allocated to groups based on stratified permuted block randomization: Stratification will be used to achieve an explicit balance for age in months (<6 months compared with ≥ 6 months) at study enrollment and gross motor development (HINE global score > 40 ambulant and ≤ 40 non ambulant). Eligible participants will be randomly assigned in permuted blocks of 2 and 6, according to computer-generated random numbers, to either GO-PLAY or standard care. The investigators anticipate that allocation concealment will be successful in preventing selection bias since the statistician conceal the allocation sequence from those assigning participants to the intervention groups, until the moment of assignment is disclosed; from which point the individual is part of the intention-to-treat (ITT) population.
The infants will be assessed on the occasions; at baseline, post intervention and follow up at 24 months corrected age
- Conditions
- Cerebral Palsy
- Being tested
- GO-PLAY, Usual care
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO-PLAYBehavioural
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.
Usual careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline at 6 months
Secondary outcomes (6)
Alberta Infant Motor Scale (AIMS)
AIMS is an observational assessment scale constructed to measure gross motor maturation in infants from birth through independent walking. 58 items are generated and organized into four positions: prone, supine, sitting and standing. Each item describes three aspects of motor performance weight-bearing, posture and antigravity movements. The overall score ranges from a minimum of 0 to a maximum of 58.
Measured: Change from baseline at 6 months
Gross Motor Function Measure (GMFM-66)
GMFM-66 is a criterion-referenced tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with CP. It consists of 5 dimensions rolling, sitting, walking, running, and jumping. The 66 items are organized in increasing difficulty order from 0 (low capacity) to 100 (high capacity) along an interval scale. Each item is scored on a four-point Likert scale (0-3). It can be used from 5 months of age, and a 5- year-old typically developing child is expected to achieve a score of 100.
Measured: Change from baseline at 6 months (if > 5 months at inclusion)
Hand Assessment in Infants (HAI)
HAI is an assessment developed for infants at risk of developing CP in the age range 3-12 months. The test procedure comprises a semi-structured video-recorded play session lasting 10- 15 min. A test kit of toys is presented to the infant to encourage and elicit exploration, making a wide range of a unilateral and bilateral hand movements observable. The HAI measures the degree and quality of goal directed actions performed with each hand separately as well as both hands together. It provides a separate score for each hand (Each Hand Sum Score 0-24), a score for both hands (Both Hands Sum Score 0-58), an asymmetry index in % illustrating possible asymmetric hand use as well as criterion referenced measure of general upper limb ability (HAI-units 0-100)
Measured: Change from baseline at 6 months (if<12 months)
The Parental Stress scale (PSS)
PSS is an 18-item questionnaire assessing parents' feelings about their parenting role, exploring both positive (emotional benefits, personal development) and negative aspects (demands on resources, feelings of stress) of parenthood. The overall score ranges from a minimum of 18 to a maximum of 90
Measured: Change from baseline at 6 months
The Depression Anxiety Stress Scales (DASS-21)
DASS-21 is an adult self-report designed to measure the emotional states of depression, anxiety and stress. It is a 4221-item questionnaire and will be used to measure parent emotional well-being
Measured: Change from baseline at 6 months
The Measure of Processes of Care 20 (MPOC-20)
MPOC-20 is a self-report measure of parents' perceptions of the extent to which the health services they and their child(ren) receive are family-centered. The 20 items consist of 5 domains; enabling and partnership, providing general information, providing specific information about the child, respectful and supportive service, and coordinated and comprehensive care.
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Apr 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital
- Responsible party
- Principal investigator, Christina Høi-Hansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christina Hoi-Hansen, Professor, Study chair, Department of Paediatrics, University Hospital Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883969
- Sponsor's protocol ID
- H-22041835
- Acronym
- GO-PLAY
- Status last verified
- May 2023
- First submitted
- 31 Mar 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy: Protocol for the Randomized Controlled GO-PLAY Trial
- ClinicalTrials.gov ID
- NCT05883969
- Acronym / sponsor ID
- GO-PLAY / H-22041835
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Signs of CP may be visible already at three months of age but the mean diagnostic age is 13 months in Denmark. An early diagnosis is important in order to start relevant intervention when neuroplasticity is highest.
The study group will be recruited from the CP-EDIT, where both the newborn- and infant-detectable risk pathway from 3-12 months corrected age are included. Neonates may have obvious risk factors in the neonatal period, but in the present study infants with clinical findings suggesting CP emerging in the first year of life are also included. An interim diagnosis based on recommended predictive tools for early diagnosis; cerebral MRI, the General Movement Assessment (if < 5 months) and the Hammersmith Infant Neurological Examination will be an inclusion criteria for this study. In addition the Hand Assessment for Infants will be included to assess early hand asymmetry.
An estimated sample size of 60 participants in total; approximately 30 per group is expected. The infants will be allocated to groups based on stratified permuted block randomization: Stratification will be used to achieve an explicit balance for age in months (<6 months compared with ≥ 6 months) at study enrollment and gross motor development (HINE global score > 40 ambulant and ≤ 40 non ambulant). Eligible participants will be randomly assigned in permuted blocks of 2 and 6, according to computer-generated random numbers, to either GO-PLAY or standard care. The investigators anticipate that allocation concealment will be successful in preventing selection bias since the statistician conceal the allocation sequence from those assigning participants to the intervention groups, until the moment of assignment is disclosed; from which point the individual is part of the intention-to-treat (ITT) population.
The infants will be assessed on the occasions; at baseline, post intervention and follow up at 24 months corrected age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention for infants | Active comparator | Behavioral: GO-PLAYEarly 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 |
| Usual care | Other | Behavioral: Usual careStandard 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 |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infants will be included in the intervention study, if they fulfil at least one of the requirements A or B:
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GO-PLAYThe 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. | Behavioural | Early intervention for infants |
| Usual careChildren 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. | Behavioural | Usual care |
Primary outcome
Peabody Developmental Motor Scales - Second edition (PDMS-2)
Time frame: Change from baseline at 6 months
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).
6 secondary outcomes
Alberta Infant Motor Scale (AIMS)
Time frame: Change from baseline at 6 months
Gross Motor Function Measure (GMFM-66)
Time frame: Change from baseline at 6 months (if > 5 months at inclusion)
Hand Assessment in Infants (HAI)
Time frame: Change from baseline at 6 months (if<12 months)
The Parental Stress scale (PSS)
Time frame: Change from baseline at 6 months
The Depression Anxiety Stress Scales (DASS-21)
Time frame: Change from baseline at 6 months
The Measure of Processes of Care 20 (MPOC-20)
Time frame: 6 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gija Rackauskaite, MD, PhD contact
Christina Hoi-Hansen, Professor study chair
Department of Paediatrics, University Hospital Rigshospitalet, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO-PLAY in people with Cerebral Palsy, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Johansen (+4530473915, m.johansen1@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales - Second edition (PDMS-2) (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.