HemiparesisPhase 1mCITNCT00473447
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy
A Phase 1 study testing Modified Constraint-induced movement therapy in people with Hemiparesis and Cerebral Palsy, run by Universita di Verona.
Trial summary
The purpose of this study is to determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy. In these children one main problem the non-use of the affected arm. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Hemiparesis, Cerebral Palsy
- What is being tested?
- Modified Constraint-induced movement therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Apr 2006
- Phase
- Phase 1
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- presence of mild-moderate arm paresis (after cerebral palsy) enabling to
- reach and grasp a pellet
- age between 1-10 years
- active participation during proposed activities
- parents consent for participation -
Who cannot join
- presence of severe behaviour disturbances
- presence of severe mental retardation (QI<60)
About this study
Official title: Phase1 Effectiveness of a Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy: a Cross-Over Study
The purpose of this study is to determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy. In these children one main problem the non-use of the affected arm. Many studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6 hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is effective in improving use and function of children paretic arm
- Conditions
- Hemiparesis, Cerebral Palsy
- Being tested
- Modified Constraint-induced movement therapy
- Keywords
- Rehabilitation, Children, Cerebral Palsy, Arm, Paresis
- Medical subject headings
- Paresis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint-induced movement therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Use Test
Measured: Four months for each patient
Secondary outcomes (1)
Arm Function Test
Measured: Four months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startJan 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Investigators
- Antonio Fiaschi, MD PhD, Study director, Department of Neurological and Vision Sciences, University of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473447
- Sponsor's protocol ID
- 800
- Acronym
- mCIT
- Status last verified
- May 2007
- First submitted
- 14 May 2007
- Last updated
- 15 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase1 Effectiveness of a Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy: a Cross-Over Study
- ClinicalTrials.gov ID
- NCT00473447
- Acronym / sponsor ID
- mCIT / 800
- Conditions
- Hemiparesis, Cerebral Palsy
- Keywords
- Rehabilitation, Children, Cerebral Palsy, Arm, Paresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 15 May 2007 (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 determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy. In these children one main problem the non-use of the affected arm. Many studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6 hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is effective in improving use and function of children paretic arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- presence of mild-moderate arm paresis (after cerebral palsy) enabling to
- reach and grasp a pellet
- age between 1-10 years
- active participation during proposed activities
- parents consent for participation -
Key exclusion criteria (2 listed)
- presence of severe behaviour disturbances
- presence of severe mental retardation (QI<60)
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 |
|---|---|---|
| Modified Constraint-induced movement therapy | Behavioural | – |
Primary outcome
Arm Use Test
Time frame: Four months for each patient
1 secondary outcome
Arm Function Test
Time frame: Four months for each patient
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 15 May 2007.
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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.
Antonio Fiaschi, MD PhD study director
Department of Neurological and Vision Sciences, University of Verona
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modified Constraint-induced movement therapy in people with Hemiparesis and Cerebral Palsy, run by Universita di Verona.
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 15 May 2007. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Arm Use Test (time frame: Four months for each patient). 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 15 May 2007.