Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis

NCT ID: NCT06191588

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Infantile Hemiplegia Constraint Induced Movement Therapy Family Bimanual Intensive Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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infant cimt

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.

Group Type EXPERIMENTAL

INFANT CIMT/BIT

Intervention Type PROCEDURE

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

Infant BIT

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

Group Type ACTIVE_COMPARATOR

INFANT CIMT/BIT

Intervention Type PROCEDURE

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

Infant CIMT/BIT

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

Group Type ACTIVE_COMPARATOR

INFANT CIMT/BIT

Intervention Type PROCEDURE

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

Conventional Therapy

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

Group Type ACTIVE_COMPARATOR

INFANT CIMT/BIT

Intervention Type PROCEDURE

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

Interventions

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INFANT CIMT/BIT

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

Intervention Type PROCEDURE

Other Intervention Names

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Constraint induced movement therapy Bimanual Intentive Therapy

Eligibility Criteria

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Inclusion Criteria

* Infantile hemiplegia
* Age from 9 months to 18 months.
* No use of the affected upper limb

Exclusion Criteria

* Associated pathologies
* Epilepsy no controlled with drugs
* No collaborated families
Minimum Eligible Age

9 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Seville

OTHER

Sponsor Role lead

Responsible Party

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Elena Piñero Pinto

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elena Piñero Pinto

Seville, , Spain

Site Status

Elena Piñero Pinto

Seville, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 40715358 (View on PubMed)

Other Identifiers

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USeville23

Identifier Type: -

Identifier Source: org_study_id

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