Brain InjuriesPIHMultiNCT05093777
Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage
A study testing Program Intensified Habilitation and Habilitation as usual in people with Brain Injuries and Cerebral Palsy, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the… Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Brain Injuries, Cerebral Palsy, Motor Skills Disorders
- What is being tested?
- Program Intensified Habilitation and Habilitation as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteNorway
- Study dates
- 10 Oct 2021to 31 Dec 2025
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 2 - 6 years at the start of the program
- a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (GMFCS level IV-V),
- being able to participate in group sessions
- having parents who want to take an active part in their child's training
- least one of the parents must speak fluent Norwegian or English.
Who cannot join
- children with progressive disorders
- co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Norwegian Model of an Intensive Habilitation Program for Young Children With Early Brain Damage - a Multicentre Randomized Controlled Trial.
By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.
Read the detailed description
Evidence-based knowledge about the effects of intensive training programs for children with severe early brain damage is limited since research on this topic has methodological weaknesses and shows conflicting results. As intensive training programs require extensive efforts from the child, parents and professionals and represent major costs, the importance of scientifically proven effects is considerable. This research project aims to measure the effects of an intensive habilitation program for young children with severe early brain damage on the child's adaptive, motor, language and social functioning and on parental empowerment, family functioning and stress. In this randomized controlled trial (RCT) 90 children will be divided into an intervention group participating in a Norwegian developed program of intensified habilitation of 12 months duration and a control group, who will receive "services as usual" during the same time period. Between-group analyses will then be performed. Due to a stepped wedge design, the control participants will then be offered training in year two of participation. Within-group analysis of results before and after training will then be performed for all participants. Standardized measures with high responsiveness in documenting intervention effectiveness will be used as primary outcome measures. Intensive training groups will be offered in all Health Regions in Norway and if successful be implemented as standard clinical practice.
- Conditions
- Brain Injuries, Cerebral Palsy, Motor Skills Disorders, Empowerment, Parent-Child Relations, Parenting
- Being tested
- Program Intensified Habilitation, Habilitation as usual
- Keywords
- brain injury, cerebral palsy, motor disability, GMFCS level, Pedi-Cat, Family Empowerment scale, Parenting stress index
- Medical subject headings
- Brain Injuries, Cerebral Palsy, Motor Skills Disorders, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program Intensified HabilitationOther
Also called PIH Multi
The program is based on a holistic and family-centered concept, which acknowledges parents as experts on their child's abilities and needs. The program involves both parents and local professionals, and includes goal setting and goal-directed treatment targeted to the needs of the individual child. The program lasts for about one year and contains three in-patient group sessions over 2 weeks. In between the children are receiving individualized home training programs at home and in pre-school/kindergarten. The children train on a daily basis, both during the inpatient sessions and in the home setting.
Habilitation as usualOther
Also called Control
When the participants are not joining the study year containing the intervention program, they will be offered habilitation services "as usual" administered by the primary health care services in the local community.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Half of the study participants will be randomized to the intensive habilitation program the first year of program. The second year of program this group of participants will be offered habilitation "as usual". Receives: Other: Program Intensified Habilitation; Other: Habilitation as usual |
| Control group | Other | Half of the study participants will be randomized to "treatment as usual" the first year of program, then offered the intensive program during the second year ("stepped wedge design"). Receives: Other: Program Intensified Habilitation; Other: Habilitation as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
Primary evaluation measure for the child
Measured: Change from baseline measure at 12 months and after 24 months
Change in Family Empowerment Scale (FES)
Primary evaluation measure for the parents
Measured: Change from baseline measure at12 months and after 24 months
Secondary outcomes (2)
Change in Gross motor function measure (GMFM-88)
Secondary evaluation measure for the child
Measured: Change from baseline measure at 12 months and after 24 months
Change in Parenting Stress Index (PSI)
Secondary evaluation measure for the parents
Measured: Change from baseline measure at 12 months and after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start10 Oct 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial (RCT) with blinded evaluation by independent researchers at baseline, at 12 months and at 24 months. A stepped-wedge design will be applied so that all study participants eventually will be offered the intervention program. Those who are randomized to control group in the first year of study, will be offered intensive training during the second year, and vice versa.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Responsible party
- Principal investigator, Jon Skranes, Sorlandet Hospital HF
- Investigators
- Jon Skranes, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093777
- Sponsor's protocol ID
- KlinBeForskSkranes
- Acronym
- PIHMulti
- Status last verified
- May 2025
- First submitted
- 28 Sep 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Norwegian Model of an Intensive Habilitation Program for Young Children With Early Brain Damage - a Multicentre Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05093777
- Acronym / sponsor ID
- PIHMulti / KlinBeForskSkranes
- Conditions
- Brain Injuries, Cerebral Palsy, Motor Skills Disorders, Empowerment, Parent-Child Relations, Parenting
- Keywords
- brain injury, cerebral palsy, motor disability, GMFCS level, Pedi-Cat, Family Empowerment scale, Parenting stress index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Oct 2021 (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.
By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.
Detailed description
Evidence-based knowledge about the effects of intensive training programs for children with severe early brain damage is limited since research on this topic has methodological weaknesses and shows conflicting results. As intensive training programs require extensive efforts from the child, parents and professionals and represent major costs, the importance of scientifically proven effects is considerable. This research project aims to measure the effects of an intensive habilitation program for young children with severe early brain damage on the child's adaptive, motor, language and social functioning and on parental empowerment, family functioning and stress. In this randomized controlled trial (RCT) 90 children will be divided into an intervention group participating in a Norwegian developed program of intensified habilitation of 12 months duration and a control group, who will receive "services as usual" during the same time period. Between-group analyses will then be performed. Due to a stepped wedge design, the control participants will then be offered training in year two of participation. Within-group analysis of results before and after training will then be performed for all participants. Standardized measures with high responsiveness in documenting intervention effectiveness will be used as primary outcome measures. Intensive training groups will be offered in all Health Regions in Norway and if successful be implemented as standard clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT) with blinded evaluation by independent researchers at baseline, at 12 months and at 24 months. A stepped-wedge design will be applied so that all study participants eventually will be offered the intervention program. Those who are randomized to control group in the first year of study, will be offered intensive training during the second year, and vice versa.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Program Intensified Habilitation, Other: Habilitation as usualHalf of the study participants will be randomized to the intensive habilitation program the first year of program. The second year of program this group of participants will be offered habilitation "as usual". |
| Control group | Other | Other: Program Intensified Habilitation, Other: Habilitation as usualHalf of the study participants will be randomized to "treatment as usual" the first year of program, then offered the intensive program during the second year ("stepped wedge design"). |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 2 - 6 years at the start of the program
- a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (GMFCS level IV-V),
- being able to participate in group sessions
- having parents who want to take an active part in their child's training
- least one of the parents must speak fluent Norwegian or English.
Key exclusion criteria (2 listed)
- children with progressive disorders
- co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.
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 |
|---|---|---|
| Program Intensified HabilitationAlso: PIH MultiThe program is based on a holistic and family-centered concept, which acknowledges parents as experts on their child's abilities and needs. The program involves both parents and local professionals, and includes goal setting and goal-directed treatment targeted to the needs of the individual child. The program lasts for about one year and contains three in-patient group sessions over 2 weeks. In between the children are receiving individualized home training programs at home and in pre-school/kindergarten. The children train on a daily basis, both during the inpatient sessions and in the home setting. | Other | Control group, Intervention group |
| Habilitation as usualAlso: ControlWhen the participants are not joining the study year containing the intervention program, they will be offered habilitation services "as usual" administered by the primary health care services in the local community. | Other | Control group, Intervention group |
Primary outcome
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
Time frame: Change from baseline measure at 12 months and after 24 months
Primary evaluation measure for the child
Change in Family Empowerment Scale (FES)
Time frame: Change from baseline measure at12 months and after 24 months
Primary evaluation measure for the parents
2 secondary outcomes
Change in Gross motor function measure (GMFM-88)
Time frame: Change from baseline measure at 12 months and after 24 months
Change in Parenting Stress Index (PSI)
Time frame: Change from baseline measure at 12 months and after 24 months
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 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Jon Skranes principal investigator
Sorlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program Intensified Habilitation and Habilitation as usual in people with Brain Injuries and Cerebral Palsy, run by Sorlandet Hospital HF 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 2 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 7 May 2026. 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?
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) (time frame: Change from baseline measure at 12 months and after 24 months). The study lists 2 primary outcomes in all. 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 7 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.