Cerebral PalsyNCT00202761
Project:Intensive Habilitation (PIH)
A study testing PIH in people with Cerebral Palsy, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals. The study hypothesis are: Intensive training will speed up the childs motor, cognitive and social development. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- PIH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2004to Dec 2018
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- About three years of age Cerebral Palsy Multidisciplinary diagnosed -
Who cannot join
- Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities
The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals.
The study hypothesis are:
Read more
Intensive training will speed up the childs motor, cognitive and social development.
Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation
- Conditions
- Cerebral Palsy
- Being tested
- PIH
- Keywords
- Cerebral palsy, Functional training, preschool children, Gross Motor Functional Classification Level, Gross motor functional Measure test, Pediatric Evaluation of Disability Inventory, Parental Stress Index
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIHBehavioural
Intensified training
| Study group | Role | What they receive |
|---|---|---|
| PIH | Experimental | Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups. Receives: Behavioral: PIH |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEDI
Measured: dec 2006
Secondary outcomes (1)
PSI
Measured: Dec 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionDec 2017
- Study completionDec 2018
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sissel Ledang, Sorlandet Hospital HF
- Investigators
- Jon Skranes, MD, PhD, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202761
- Sponsor's protocol ID
- SSHF70339
- Status last verified
- Mar 2022
- First submitted
- 12 Sep 2005
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities
- ClinicalTrials.gov ID
- NCT00202761
- Acronym / sponsor ID
- SSHF70339
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Functional training, preschool children, Gross Motor Functional Classification Level, Gross motor functional Measure test, Pediatric Evaluation of Disability Inventory, Parental Stress Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Mar 2004
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Sep 2005 (estimated)
- 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.
The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals.
The study hypothesis are:
Intensive training will speed up the childs motor, cognitive and social development.
Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIH | Experimental | Behavioral: PIHIntensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- About three years of age Cerebral Palsy Multidisciplinary diagnosed -
Key exclusion criteria (1 listed)
- Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -
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 |
|---|---|---|
| PIHIntensified training | Behavioural | PIH |
Primary outcome
PEDI
Time frame: dec 2006
1 secondary outcome
PSI
Time frame: Dec 2006
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 28 Mar 2022.
- Page describing the intensive habilitation program, and the childrens habilitation department at Sorlandet Hospital, HF , NorwayLink provided by the sponsor.
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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, MD, PhD 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 PIH in people with 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 1 inclusion and 1 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 28 Mar 2022. 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?
PEDI (time frame: dec 2006). 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 28 Mar 2022.