Cerebral PalsyNCT03264339
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
A study testing Small Step Program in people with Cerebral Palsy, run by St. Olavs Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 8 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Small Step Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 7 Sep 2017to 7 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
The efficacy of the Small Step program is presently being investigated through a randomized controlled trial (NCT02166801) at Karolinska Institutet (KI) in Stockholm, Sweden. In the original project proposal for the current study, the plan was to contribute with inclusion of children from St. Olavs Hospital to the randomized controlled study initiated at KI. This project proposal has previously been approved by the Regional Ethical Committee (REK) for Medical Research in Mid-Norway (2016/1366). However, the researchers at KI have now completed the inclusion of participants for the randomized controlled study, and their preliminary results indicate that there is a large individual variation among the included participants regarding effect of the Small Step program. In agreement with the researchers at KI, it was therefore decided to change the design of the current study using Single Subject Research Design, a study design that is more appropriate to investigate individual response to treatment. The change in study design has been approved by REK (2016/1366-10).
Participation in this study is based on informed consent from the parents, and the child and the family participating in the project will be offered a potentially effective early intervention program that they would otherwise not be able to access.
The Small Step intervention program has three alternating treatment foci (B, C, and D) divided into five different steps, each lasting for 6 weeks (in total 30 weeks). The three treatment foci are Communication, Hand function and Mobility/gross motor function. The Hand function and Mobility steps will be conducted during two time-periods and the order will be randomised. Communication will have one intervention period during step III. The training will be conducted in the children's home by the parents on a daily basis under weekly supervision by the therapist responsible for each specific step of the intervention. General principles for the small step program are: a) collaborative goal-setting; b) promote infant's self-initiated actions; c) use of enriched home environment, d) intensity and repetition.
Before and after the intervention, there is a baseline phase with no treatment (A) and a withdrawal phase with no treatment (A), resulting in the following design: A-B-C-D-B-C-A. In addition, there is a follow-up phase when the children are 2 years of age.
- Conditions
- Cerebral Palsy
- Being tested
- Small Step Program
- Keywords
- Infant, Hand/Growth & Development, Motor activity, Exercise, Communication
- Medical subject headings
- Cerebral Palsy, Motor Activity, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Step ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Smal step | Experimental | Small Step Program, comprising 3 treatment focus areas (Hand use, Mobility, Communication) Receives: Behavioral: Small Step Program |
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 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.
Measured: up to 2 years
Secondary outcomes (5)
Hand Assessment for Infants (HAI)
identifies and measures upper limb asymmetry and general manual development from 3-12 months
Measured: up to 2 years
Alberta Infant Motor Scale (AIMS)
identifies infants with delayed or deviant motor development up to 18 months of age
Measured: up to 2 years
Gross Motor Function Measure (GMFM-66)
an observational, standardized and criterion-referenced measure, developed to evaluate change in gross motor function in children with cerebral palsy (CP)
Measured: up to 2 years
Parent-Child Early Relational Assessment (PC-ERA)
assesses parent-child interactions to capture the affective and behavioral characteristics that parent and child bring to the interaction, and the quality or tone of the relationship
Measured: up to 2 years
Treatment Expectancy and Credibility Survey (TCS) - modification
assesses treatment expectations
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start7 Sep 2017
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject research design (SSRD) will be used with each participant serving as his/her own control.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Elisabeth Selvaag, md, Study director, St Olavs Hospital, Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264339
- Sponsor's protocol ID
- 2016/1366
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2017
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: (in progress)
Publications
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.
PubMed 27809886Elvrum 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.
PubMed 39274500Karstad 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.
PubMed 36615077
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03264339
- Acronym / sponsor ID
- 2016/1366
- Conditions
- Cerebral Palsy
- Keywords
- Infant, Hand/Growth & Development, Motor activity, Exercise, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 29 Aug 2017 (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.
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.
Detailed description
The efficacy of the Small Step program is presently being investigated through a randomized controlled trial (NCT02166801) at Karolinska Institutet (KI) in Stockholm, Sweden. In the original project proposal for the current study, the plan was to contribute with inclusion of children from St. Olavs Hospital to the randomized controlled study initiated at KI. This project proposal has previously been approved by the Regional Ethical Committee (REK) for Medical Research in Mid-Norway (2016/1366). However, the researchers at KI have now completed the inclusion of participants for the randomized controlled study, and their preliminary results indicate that there is a large individual variation among the included participants regarding effect of the Small Step program. In agreement with the researchers at KI, it was therefore decided to change the design of the current study using Single Subject Research Design, a study design that is more appropriate to investigate individual response to treatment. The change in study design has been approved by REK (2016/1366-10).
Participation in this study is based on informed consent from the parents, and the child and the family participating in the project will be offered a potentially effective early intervention program that they would otherwise not be able to access.
The Small Step intervention program has three alternating treatment foci (B, C, and D) divided into five different steps, each lasting for 6 weeks (in total 30 weeks). The three treatment foci are Communication, Hand function and Mobility/gross motor function. The Hand function and Mobility steps will be conducted during two time-periods and the order will be randomised. Communication will have one intervention period during step III. The training will be conducted in the children's home by the parents on a daily basis under weekly supervision by the therapist responsible for each specific step of the intervention. General principles for the small step program are: a) collaborative goal-setting; b) promote infant's self-initiated actions; c) use of enriched home environment, d) intensity and repetition.
Before and after the intervention, there is a baseline phase with no treatment (A) and a withdrawal phase with no treatment (A), resulting in the following design: A-B-C-D-B-C-A. In addition, there is a follow-up phase when the children are 2 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject research design (SSRD) will be used with each participant serving as his/her own control.
| Arm | Type | Receives |
|---|---|---|
| Smal step | Experimental | Behavioral: Small Step ProgramSmall Step Program, comprising 3 treatment focus areas (Hand use, Mobility, Communication) |
Who may qualify
- Ages
- 3 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Small Step ProgramThe 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). | Behavioural | Smal step |
Primary outcome
Peabody Developmental Motor Scales, second edition (PDMS-2)
Time frame: up to 2 years
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.
5 secondary outcomes
Hand Assessment for Infants (HAI)
Time frame: up to 2 years
Alberta Infant Motor Scale (AIMS)
Time frame: up to 2 years
Gross Motor Function Measure (GMFM-66)
Time frame: up to 2 years
Parent-Child Early Relational Assessment (PC-ERA)
Time frame: up to 2 years
Treatment Expectancy and Credibility Survey (TCS) - modification
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 27809886Eliasson 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.
- Derived from this study: PubMed 39274500Elvrum 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.
- Derived from this study: PubMed 36615077Karstad 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.
- Individual participant dataSharing planned: Yes. (in progress)
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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. This study is not recruiting at the moment.
Elisabeth Selvaag, md study director
St Olavs Hospital, Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Step Program in people with Cerebral Palsy, run by St. Olavs Hospital at 1 site in Norway.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales, second edition (PDMS-2) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264339, which also lists 3 linked publications.
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 9 Sep 2021.