Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

NCT ID: NCT04642872

Last Updated: 2020-11-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-28

Study Completion Date

2021-03-20

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 familes.

Detailed Description

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Conditions

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Infantile Hemiplegia Upper Extremity Paresis Family Constraint Induced Movement Therapy Bimanual Intensive Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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infant cimt

Group Type EXPERIMENTAL

Infant BIT

Intervention Type OTHER

Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination

Infant CIMT/BIT

Intervention Type OTHER

Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.

Conventional therapy

Intervention Type OTHER

Following the usual therapy in the baby.

Infant BIT

Group Type ACTIVE_COMPARATOR

Infant CIMT/BIT

Intervention Type OTHER

Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.

Conventional therapy

Intervention Type OTHER

Following the usual therapy in the baby.

infant cimt

Intervention Type OTHER

use of unaffected hand containment to improve the use of affected hand with unimanual activities

Infant CIMT/BIT

Group Type ACTIVE_COMPARATOR

Infant BIT

Intervention Type OTHER

Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination

Conventional therapy

Intervention Type OTHER

Following the usual therapy in the baby.

infant cimt

Intervention Type OTHER

use of unaffected hand containment to improve the use of affected hand with unimanual activities

Conventional Therapy

Group Type ACTIVE_COMPARATOR

Infant BIT

Intervention Type OTHER

Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination

Infant CIMT/BIT

Intervention Type OTHER

Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.

infant cimt

Intervention Type OTHER

use of unaffected hand containment to improve the use of affected hand with unimanual activities

Interventions

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Infant BIT

Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination

Intervention Type OTHER

Infant CIMT/BIT

Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.

Intervention Type OTHER

Conventional therapy

Following the usual therapy in the baby.

Intervention Type OTHER

infant cimt

use of unaffected hand containment to improve the use of affected hand with unimanual activities

Intervention Type OTHER

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 medicins
* 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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CEU San Pablo University

OTHER

Sponsor Role lead

Responsible Party

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Rocio Palomo Carrión

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hemiweb

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rocío Palomo Carrión

Role: CONTACT

Phone: 606417213

Email: [email protected]

Facility Contacts

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Rocío Palomo Carrión

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36420043 (View on PubMed)

Other Identifiers

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infant CIMT/BIT

Identifier Type: -

Identifier Source: org_study_id