Program Intensive Habilitation (PIH) for Young Children With Early Brain

Status Recruiting

Clinical 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 consequences of early brain damage.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05093777
Study type	Interventional
Source	Sorlandet Hospital HF
Contact	Jon S Skranes, MD PhD
Phone	99390285
Email	joskra@online.no
Status	Recruiting
Phase	N/A
Start date	October 10, 2021
Completion date	March 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05317234` - Genetic Predisposition in Cerebral Palsy	N/A
Recruiting	`NCT05576948` - Natural History of Cerebral Palsy Prospective Study
Completed	`NCT04119063` - Evaluating Wearable Robotic Assistance on Gait	Early Phase 1
Completed	`NCT03264339` - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy	N/A
Completed	`NCT05551364` - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy	N/A
Completed	`NCT03902886` - Independent Walking Onset of Children With Cerebral Palsy
Recruiting	`NCT05571033` - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy	N/A
Not yet recruiting	`NCT04081675` - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed	`NCT02167022` - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy	N/A
Completed	`NCT04012125` - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy	N/A
Enrolling by invitation	`NCT05619211` - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities	Phase 1
Completed	`NCT04489498` - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed	`NCT03677193` - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy	N/A
Completed	`NCT04093180` - Intensive Neurorehabilitation for Cerebral Palsy	N/A
Completed	`NCT02909127` - The Pediatric Eating Assessment Tool
Not yet recruiting	`NCT06377982` - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy	Phase 1
Not yet recruiting	`NCT06007885` - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.	N/A
Not yet recruiting	`NCT03183427` - Corpus Callosum Size in Patients With Pineal Cyst	N/A
Active, not recruiting	`NCT03078621` - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy	Phase 1/Phase 2
Completed	`NCT02897024` - A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage — PIHMulti

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms