Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis

Feasibility and Effectiveness of Home-base Early Intensive Therapy in Unilateral Cerebral Palsy (Ucp-HEIT) Under-2-years-old

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.

Study Overview

• Status: Completed
• Conditions: Family; Infantile Hemiplegia; Constraint Induced Movement Therapy; Bimanual Intensive Therapy
• Intervention / Treatment: Procedure: INFANT CIMT/BIT

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Pinero-Pinto, PhD; Phone Number: +34655108763; Email: epinero@us.es

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Elena Piñero Pinto
  • Seville, Spain, 41009
    • Elena Piñero Pinto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: INFANT CIMT/BIT; Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT); Other Names: Constraint induced movement therapy; Bimanual Intentive Therapy
Active Comparator: 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	Procedure: INFANT CIMT/BIT; Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT); Other Names: Constraint induced movement therapy; Bimanual Intentive Therapy
Active Comparator: 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	Procedure: INFANT CIMT/BIT; Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT); Other Names: Constraint induced movement therapy; Bimanual Intentive Therapy
Active Comparator: 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	Procedure: INFANT CIMT/BIT; Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT); Other Names: Constraint induced movement therapy; Bimanual Intentive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mini Assisting Hand Assesment	Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire for families	Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.	10 weeks

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: USeville23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing data
• IPD Sharing Time Frame: For a year since the study ends
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No