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Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

Primary Purpose

Infantile Hemiplegia, Upper Extremity Paresis, Family

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Infant BIT
Infant CIMT/BIT
Conventional therapy
infant cimt
Sponsored by
CEU San Pablo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Hemiplegia

Eligibility Criteria

9 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HemiwebRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

infant cimt

Infant BIT

Infant CIMT/BIT

Conventional Therapy

Arm Description

Outcomes

Primary Outcome Measures

mini Assisting Hand Assesment
Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.

Secondary Outcome Measures

Satisfaction questionnaire for familes
Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.

Full Information

First Posted
November 3, 2020
Last Updated
November 22, 2020
Sponsor
CEU San Pablo University
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1. Study Identification

Unique Protocol Identification Number
NCT04642872
Brief Title
Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.
Official Title
Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2019 (Actual)
Primary Completion Date
January 18, 2021 (Anticipated)
Study Completion Date
March 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CEU San Pablo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Hemiplegia, Upper Extremity Paresis, Family, Constraint Induced Movement Therapy, Bimanual Intensive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
infant cimt
Arm Type
Experimental
Arm Title
Infant BIT
Arm Type
Active Comparator
Arm Title
Infant CIMT/BIT
Arm Type
Active Comparator
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Infant BIT
Intervention Description
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Intervention Type
Other
Intervention Name(s)
Infant CIMT/BIT
Intervention Description
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
Following the usual therapy in the baby.
Intervention Type
Other
Intervention Name(s)
infant cimt
Intervention Description
use of unaffected hand containment to improve the use of affected hand with unimanual activities
Primary Outcome Measure Information:
Title
mini Assisting Hand Assesment
Description
Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Satisfaction questionnaire for familes
Description
Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rocío Palomo Carrión
Phone
606417213
Email
rociopalomotoledo@gmail.com
Facility Information:
Facility Name
Hemiweb
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocío Palomo Carrión
Phone
606417213
Email
rociopalomotoledo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

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