NCT06191588

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 families.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

December 19, 2023

Last Update Submit

March 28, 2024

Conditions

Infantile HemiplegiaConstraint Induced Movement TherapyFamilyBimanual Intensive Therapy

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 families

    10 weeks

Study Arms (4)

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.

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

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

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

Procedure: INFANT CIMT/BIT

Interventions

INFANT CIMT/BITPROCEDURE

Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT)

Also known as: Constraint induced movement therapy, Bimanual Intentive Therapy
Conventional TherapyInfant BITInfant CIMT/BITinfant cimt

Eligibility Criteria

Age9 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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 drugs
  • No collaborated families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elena Piñero Pinto

Seville, 41009, Spain

Location

Elena Piñero Pinto

Seville, 41013, Spain

Location

Related Publications (1)

  • 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. 2025 Jul 26. doi: 10.1038/s41390-025-04306-4. Online ahead of print.

    PMID: 40715358DERIVED

MeSH Terms

Conditions

Hemiplegia

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

December 20, 2023

Primary Completion

March 20, 2024

Study Completion

March 20, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Sharing data

Shared Documents
STUDY PROTOCOL
Time Frame
For a year since the study ends

Locations

ES(2)