Cerebral PalsyPhase 3NCT00922077
Individualized Neurodevelopmental Treatment
A Phase 3 study testing standard physical therapy program with emphasis on dynamic balance exercises in people with Cerebral Palsy, run by Hellenic Society for Disabled Children at 1 site in Greece.
Trial summary
The purpose of the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data. Read more about this study
- Who is it for?
- Ages 6 to 9 years, women only
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- standard physical therapy program with emphasis on dynamic balance exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2008to Apr 2008
- Phase
- Phase 3
- 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 6 to 9 years
- Women only
- Child
Who may be able to join
- spastic tetraplegia
Who cannot join
- vision problems
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hellenic Society for Disabled Children
Thessaloniki, THessaloniki, 25155
About this study
The purpose of the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data.
Read the detailed description
The intervention lasted 6 weeks. There were 3 sessions per week. At each session there was a part of standard physical therapy program and there was also a part with emphasis on dynamic balance exercises.
- Conditions
- Cerebral Palsy
- Being tested
- standard physical therapy program with emphasis on dynamic balance exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard physical therapy program with emphasis on dynamic balance exercisesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Society for Disabled Children
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922077
- Sponsor's protocol ID
- 001-Nikodelis
- Status last verified
- Jun 2009
- First submitted
- 1 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Neurodevelopmental Treatment
- ClinicalTrials.gov ID
- NCT00922077
- Acronym / sponsor ID
- 001-Nikodelis
- Conditions
- Cerebral Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hellenic Society for Disabled ChildrenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Jun 2009 (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 the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data.
Detailed description
The intervention lasted 6 weeks. There were 3 sessions per week. At each session there was a part of standard physical therapy program and there was also a part with emphasis on dynamic balance exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 6 to 9 years
- Sex
- Female only
- Age groups
- Child
Key inclusion criteria (1 listed)
- spastic tetraplegia
Key exclusion criteria (1 listed)
- vision problems
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 |
|---|---|---|
| standard physical therapy program with emphasis on dynamic balance exercises | Behavioural | – |
Primary outcome
Not reported in the source record.
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 17 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard physical therapy program with emphasis on dynamic balance exercises in people with Cerebral Palsy, run by Hellenic Society for Disabled Children at 1 site in Greece.
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 17 Jun 2009. 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 Greece. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 17 Jun 2009.