Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.
Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.
1 other identifier
interventional
40
1 country
1
Brief 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, executing them at home by familes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2019
CompletedFirst Submitted
Initial submission to the registry
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2021
CompletedNovember 24, 2020
November 1, 2020
1.5 years
November 3, 2020
November 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
mini Assisting Hand Assesment
Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.
10 weeks
Secondary Outcomes (1)
Satisfaction questionnaire for familes
10 weeks
Study Arms (4)
infant cimt
EXPERIMENTALInfant BIT
ACTIVE COMPARATORInfant CIMT/BIT
ACTIVE COMPARATORConventional Therapy
ACTIVE COMPARATORInterventions
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Following the usual therapy in the baby.
use of unaffected hand containment to improve the use of affected hand with unimanual activities
Eligibility Criteria
You may qualify if:
- Infantile hemiplegia
- Age from 9 months to 18 months.
- No use of the affected upper limb
You may not qualify if:
- Associated pathologies
- Epilepsy no controlled with medicins
- No collaborated families
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hemiweb
Barcelona, Spain
Related Publications (1)
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.
PMID: 36420043DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 24, 2020
Study Start
July 28, 2019
Primary Completion
January 18, 2021
Study Completion
March 20, 2021
Last Updated
November 24, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share