HemiplegiaNCT01214902
Constraint Induced Movement Therapy (CIMT) in Babies Home Program
A study testing Constraint induced movement therapy (CIMT) and play in people with Hemiplegia and Cerebral Palsy, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT. Read more about this study
- Who is it for?
- Ages 7 to 18 months
- Conditions the study is for
- Hemiplegia, Cerebral Palsy
- What is being tested?
- Constraint induced movement therapy (CIMT) and play
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to Dec 2012
- 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 7 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy
Who cannot join
- Epilepsy not treated
Trial locations and contacts
1 site in 1 country.
Rena Shara chamudot, Ms.c contact
Israel1 site, 1 recruiting
- Recruiting
ShaareZMC
Jerusalem
Varda Gross-Tzur, Prof.
About this study
The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.
- Conditions
- Hemiplegia, Cerebral Palsy
- Being tested
- Constraint induced movement therapy (CIMT), play
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint induced movement therapy (CIMT)Device
Also called Modifide constraint induced movoment therapy
soft mitten worn on the non hemiplegic hand
playBehavioural
play which encourages the use of the hemiplegic hand
| Study group | Role | What they receive |
|---|---|---|
| Experimental CIMT | Experimental | Two month home program that includes restricting the non hemiplegic hand an hour a day during play Receives: Device: Constraint induced movement therapy (CIMT) |
| Active Play | Active comparator | Two month home program that includes active use of hemiplegic hand during play one hour a day Receives: Behavioral: play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assistive Hand Assessment
Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities
Measured: after two months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startMay 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214902
- Sponsor's protocol ID
- chamudotctil
- Status last verified
- Jun 2010
- First submitted
- 27 Jul 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chamudot R, Parush S, Rigbi A, Horovitz R, Gross-Tsur V. Effectiveness of Modified Constraint-Induced Movement Therapy Compared With Bimanual Therapy Home Programs for Infants With Hemiplegia: A Randomized Controlled Trial. Am J Occup Ther. 2018 Nov/Dec;72(6):7206205010p1-7206205010p9. doi: 10.5014/ajot.2018.025981.
PubMed 30760393Chamudot R, Parush S, Rigbi A, Gross-Tsur V. Brain Lesions as a Predictor of Therapeutic Outcomes of Hand Function in Infants With Unilateral Cerebral Palsy. J Child Neurol. 2018 Dec;33(14):918-924. doi: 10.1177/0883073818801632. Epub 2018 Oct 11.
PubMed 30307370
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint Induced Movement Therapy (CIMT) in Babies Home Program
- ClinicalTrials.gov ID
- NCT01214902
- Acronym / sponsor ID
- chamudotctil
- Conditions
- Hemiplegia, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Oct 2010 (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 research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental CIMT | Experimental | Device: Constraint induced movement therapy (CIMT)Two month home program that includes restricting the non hemiplegic hand an hour a day during play |
| Active Play | Active comparator | Behavioral: playTwo month home program that includes active use of hemiplegic hand during play one hour a day |
Who may qualify
- Ages
- 7 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy
Key exclusion criteria (1 listed)
- Epilepsy not treated
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 |
|---|---|---|
| Constraint induced movement therapy (CIMT)Also: Modifide constraint induced movoment therapysoft mitten worn on the non hemiplegic hand | Device | Experimental CIMT |
| playplay which encourages the use of the hemiplegic hand | Behavioural | Active Play |
Primary outcome
Assistive Hand Assessment
Time frame: after two months of treatment
Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
- Derived from this study: PubMed 30760393Chamudot R, Parush S, Rigbi A, Horovitz R, Gross-Tsur V. Effectiveness of Modified Constraint-Induced Movement Therapy Compared With Bimanual Therapy Home Programs for Infants With Hemiplegia: A Randomized Controlled Trial. Am J Occup Ther. 2018 Nov/Dec;72(6):7206205010p1-7206205010p9. doi: 10.5014/ajot.2018.025981.
- Derived from this study: PubMed 30307370Chamudot R, Parush S, Rigbi A, Gross-Tsur V. Brain Lesions as a Predictor of Therapeutic Outcomes of Hand Function in Infants With Unilateral Cerebral Palsy. J Child Neurol. 2018 Dec;33(14):918-924. doi: 10.1177/0883073818801632. Epub 2018 Oct 11.
Related trials for Hemiplegia
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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.
Rena Shara chamudot, Ms.c contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint induced movement therapy (CIMT) and play in people with Hemiplegia and Cerebral Palsy, run by Shaare Zedek Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 21 Jun 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rena Shara chamudot, Ms.c (chamudot@012.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assistive Hand Assessment (time frame: after two months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214902, which also lists 2 linked publications.
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 21 Jun 2011; AzTrials last refreshed its copy on 5 Nov 2026.