An interventional study of Program Intensified Habilitation and Habilitation as usual in Brain Injuries, Cerebral Palsy and Motor Skills Disorders, sponsored by Sorlandet Hospital HF. Completed at 1 site in Norway. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Sorlandet Hospital HF · Not applicable, Interventional, and Treatment
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.
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's enrollment of 93 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Sorlandet Hospital HF is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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".
Other: Program Intensified Habilitation · Other: Habilitation as usual
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").
Other: Program Intensified Habilitation · Other: Habilitation as usual
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.
Also known as: PIH Multi
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.
Also known as: Control
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
Primary evaluation measure for the child
Time frame: Change from baseline measure at 12 months and after 24 months
Change in Family Empowerment Scale (FES)
Primary evaluation measure for the parents
Time frame: Change from baseline measure at12 months and after 24 months
Change in Gross motor function measure (GMFM-88)
Secondary evaluation measure for the child
Time frame: Change from baseline measure at 12 months and after 24 months
Change in Parenting Stress Index (PSI)
Secondary evaluation measure for the parents
Time frame: Change from baseline measure at 12 months and after 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Dec 2025, 50 months.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 50 months is above that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Sorlandet Hospital HF