Infantile HemiplegiaNCT04642872
Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.
A study testing Infant BIT, Infant CIMT/BIT and Conventional therapy in people with Infantile Hemiplegia and Upper Extremity Paresis, run by CEU San Pablo University at 1 site 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, Upper Extremity Paresis, Family
- What is being tested?
- Infant BIT, Infant CIMT/BIT and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jul 2019to 20 Mar 2021
- 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 medicins
- No collaborated families
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hemiweb
Barcelona
Rocío Palomo Carrión, 606417213, rociopalomotoledo@gmail.com
About this study
Official title: Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.
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 familes.
- Conditions
- Infantile Hemiplegia, Upper Extremity Paresis, Family, Constraint Induced Movement Therapy, Bimanual Intensive Therapy
- Being tested
- Infant BIT, Infant CIMT/BIT, Conventional therapy, infant cimt
- Medical subject headings
- Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant BITOther
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Infant CIMT/BITOther
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Conventional therapyOther
Following the usual therapy in the baby.
infant cimtOther
use of unaffected hand containment to improve the use of affected hand with unimanual activities
| Study group | Role | What they receive |
|---|---|---|
| infant cimt | Experimental | Not described Receives: Other: Infant BIT; Other: Infant CIMT/BIT; Other: Conventional therapy |
| Infant BIT | Active comparator | Not described Receives: Other: Infant CIMT/BIT; Other: Conventional therapy; Other: infant cimt |
| Infant CIMT/BIT | Active comparator | Not described Receives: Other: Infant BIT; Other: Conventional therapy; Other: infant cimt |
| Conventional Therapy | Active comparator | Not described Receives: Other: Infant BIT; Other: Infant CIMT/BIT; Other: infant cimt |
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 familes
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 posted24 Nov 2020
- Study start28 Jul 2019
- Primary completion18 Jan 2021 (estimated)
- Study completion20 Mar 2021 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocio Palomo Carrión, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642872
- Sponsor's protocol ID
- infant CIMT/BIT
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palomo-Carrion R, Pinero-Pinto E, Romay-Barrero H, Escobio-Prieto I, Lillo-Navarro C, Romero-Galisteo RP. Shall we start? Ready, set, go! Toward early intervention in infants with unilateral cerebral palsy. A randomized clinical trial protocol. Ther Adv Chronic Dis. 2022 Nov 14;13:20406223221136059. doi: 10.1177/20406223221136059. eCollection 2022.
PubMed 36420043
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04642872
- Acronym / sponsor ID
- infant CIMT/BIT
- Conditions
- Infantile Hemiplegia, Upper Extremity Paresis, Family, Constraint Induced Movement Therapy, Bimanual Intensive Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 28 Jul 2019 (actual)
- Primary completion
- 18 Jan 2021 (estimated)
- Study completion
- 20 Mar 2021 (estimated)
- First posted
- 24 Nov 2020 (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 familes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| infant cimt | Experimental | Other: Infant BIT, Other: Infant CIMT/BIT, Other: Conventional therapy |
| Infant BIT | Active comparator | Other: Infant CIMT/BIT, Other: Conventional therapy, Other: infant cimt |
| Infant CIMT/BIT | Active comparator | Other: Infant BIT, Other: Conventional therapy, Other: infant cimt |
| Conventional Therapy | Active comparator | Other: Infant BIT, Other: Infant CIMT/BIT, Other: infant cimt |
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 medicins
- 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 BITNot use of unaffected hand containment. Both hand are use to improve the bimanual coordination | Other | Conventional Therapy, Infant CIMT/BIT, infant cimt |
| Infant CIMT/BITUse unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment. | Other | Conventional Therapy, Infant BIT, infant cimt |
| Conventional therapyFollowing the usual therapy in the baby. | Other | Infant BIT, Infant CIMT/BIT, infant cimt |
| infant cimtuse of unaffected hand containment to improve the use of affected hand with unimanual activities | Other | Conventional Therapy, Infant BIT, Infant CIMT/BIT |
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 familes
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 36420043Palomo-Carrion R, Pinero-Pinto E, Romay-Barrero H, Escobio-Prieto I, Lillo-Navarro C, Romero-Galisteo RP. Shall we start? Ready, set, go! Toward early intervention in infants with unilateral cerebral palsy. A randomized clinical trial protocol. Ther Adv Chronic Dis. 2022 Nov 14;13:20406223221136059. doi: 10.1177/20406223221136059. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Infantile Hemiplegia
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant BIT, Infant CIMT/BIT and Conventional therapy in people with Infantile Hemiplegia and Upper Extremity Paresis, run by CEU San Pablo University at 1 site 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocío Palomo Carrión (606417213, rociopalomotoledo@gmail.com), or a site near the patient. 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 NCT04642872, 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 24 Nov 2020.