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NCT06191588 Clinical Trial

Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis

Family Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06191588
Other study ID # USeville23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2023
Est. completion date March 20, 2024

Study information
Verified date March 2024
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 20, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers No
Gender All
Age group 9 Months to 18 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• INFANT CIMT/BIT
Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT)

Locations
Country Name City State
Spain Elena Piñero Pinto Sevilla
Spain Elena Piñero Pinto Seville

Sponsors (1)
Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary mini Assisting Hand Assesment Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months. 10 weeks
Secondary Satisfaction questionnaire for families Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies. 10 weeks
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