Infantile HemiplegiaNCT06191588
Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis
A study testing INFANT CIMT/BIT in people with Infantile Hemiplegia and Constraint Induced Movement Therapy, run by University of Seville at 2 sites in Spain.
Trial summary
mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks… Read more about this study
- Who is it for?
- Ages 9 to 18 months
- Conditions the study is for
- Infantile Hemiplegia, Constraint Induced Movement Therapy, Family
- What is being tested?
- INFANT CIMT/BIT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Dec 2023to 20 Mar 2024
- 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 9 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infantile hemiplegia
- Age from 9 months to 18 months.
- No use of the affected upper limb
Who cannot join
- Associated pathologies
- Epilepsy no controlled with drugs
- No collaborated families
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Feasibility and Effectiveness of Home-base Early Intensive Therapy in Unilateral Cerebral Palsy (Ucp-HEIT) Under-2-years-old
mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by families.
- Conditions
- Infantile Hemiplegia, Constraint Induced Movement Therapy, Family, Bimanual Intensive Therapy
- Being tested
- INFANT CIMT/BIT
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFANT CIMT/BITProcedure or surgery
Also called Constraint induced movement therapy, Bimanual Intentive Therapy
Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT)
| Study group | Role | What they receive |
|---|---|---|
| infant cimt | Experimental | Other: Infant BIT Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Other: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: Conventional therapy Following the usual therapy in the baby. Receives: Procedure: INFANT CIMT/BIT |
| Infant BIT | Active comparator | Other: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: Conventional therapy Following the usual therapy in the baby.
Other: infant cimt use of unaffected hand containment to improve the use of affected hand with unimanual activities Receives: Procedure: INFANT CIMT/BIT |
| Infant CIMT/BIT | Active comparator | Other: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: Conventional therapy Following the usual therapy in the baby.
Other: infant cimt use of unaffected hand containment to improve the use of affected hand with unimanual activities Receives: Procedure: INFANT CIMT/BIT |
| Conventional Therapy | Active comparator | Other: Infant BIT Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Other: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: infant cimt use of unaffected hand containment to improve the use of affected hand with unimanual activities Receives: Procedure: INFANT CIMT/BIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
mini Assisting Hand Assesment
Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.
Measured: 10 weeks
Secondary outcomes (1)
Satisfaction questionnaire for families
Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Dec 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile 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
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Piñero Pinto, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191588
- Sponsor's protocol ID
- USeville23
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing data
Publications
Palomo-Carrion R, Pinero-Pinto E, Lirio-Romero C, Romay-Barrero H, Ferri-Morales A, Romero-Galisteo RP. Home-based early intensive manual therapy in unilateral cerebral palsy under 2 years of age. Pediatr Res. 2026 Jun;99(5):1772-1782. doi: 10.1038/s41390-025-04306-4. Epub 2025 Jul 26.
PubMed 40715358
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Home-base Early Intensive Therapy in Unilateral Cerebral Palsy (Ucp-HEIT) Under-2-years-old
- ClinicalTrials.gov ID
- NCT06191588
- Acronym / sponsor ID
- USeville23
- Conditions
- Infantile Hemiplegia, Constraint Induced Movement Therapy, Family, Bimanual Intensive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- 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.
mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| infant cimt | Experimental | Procedure: INFANT CIMT/BITOther: Infant BIT Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination Other: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment. Other: Conventional therapy Following the usual therapy in the baby. |
| Infant BIT | Active comparator | Procedure: INFANT CIMT/BITOther: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment. Other: Conventional therapy Following the usual therapy in the baby. Other: infant cimt use of unaffected hand containment to improve the use of affected hand with unimanual activities |
| Infant CIMT/BIT | Active comparator | Procedure: INFANT CIMT/BITOther: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment. Other: Conventional therapy Following the usual therapy in the baby. Other: infant cimt use of unaffected hand containment to improve the use of affected hand with unimanual activities |
| Conventional Therapy | Active comparator | Procedure: INFANT CIMT/BITOther: Infant BIT Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination Other: Infant CIMT/BIT Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment. Other: infant cimt use of unaffected hand containment to improve the use of affected hand with unimanual activities |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infantile hemiplegia
- Age from 9 months to 18 months.
- No use of the affected upper limb
Key exclusion criteria (3 listed)
- Associated pathologies
- Epilepsy no controlled with drugs
- No collaborated families
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 |
|---|---|---|
| INFANT CIMT/BITAlso: Constraint induced movement therapy, Bimanual Intentive TherapyConstraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT) | Procedure or surgery | Conventional Therapy, Infant BIT, Infant CIMT/BIT, infant cimt |
Primary outcome
mini Assisting Hand Assesment
Time frame: 10 weeks
Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.
1 secondary outcome
Satisfaction questionnaire for families
Time frame: 10 weeks
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 29 Mar 2024.
- Derived from this study: PubMed 40715358Palomo-Carrion R, Pinero-Pinto E, Lirio-Romero C, Romay-Barrero H, Ferri-Morales A, Romero-Galisteo RP. Home-based early intensive manual therapy in unilateral cerebral palsy under 2 years of age. Pediatr Res. 2026 Jun;99(5):1772-1782. doi: 10.1038/s41390-025-04306-4. Epub 2025 Jul 26.
- Individual participant dataSharing planned: Yes. Sharing data
Related trials for Infantile Hemiplegia
Not yet recruiting
Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
Cerebral Palsy, Hemiplegia, Infantile
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFANT CIMT/BIT in people with Infantile Hemiplegia and Constraint Induced Movement Therapy, run by University of Seville at 2 sites in Spain.
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 3 inclusion and 3 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
mini Assisting Hand Assesment (time frame: 10 weeks). 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 NCT06191588, which also lists 1 linked publication.
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 29 Mar 2024.