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Clinical Trials/NCT06191588
NCT06191588
Completed
Not Applicable

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

University of Seville1 site in 1 country10 target enrollmentDecember 20, 2023
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ConditionsInfantile HemiplegiaConstraint Induced Movement TherapyFamilyBimanual Intensive Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infantile Hemiplegia
Sponsor
University of Seville
Enrollment
10
Locations
1
Primary Endpoint
mini Assisting Hand Assesment
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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 families.

Registry
clinicaltrials.gov
Start Date
December 20, 2023
End Date
March 20, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Piñero Pinto

Professor

University of Seville

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 drugs
  • •No collaborated families

Outcomes

Primary Outcomes

mini Assisting Hand Assesment

Time Frame: 10 weeks

Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.

Secondary Outcomes

  • Satisfaction questionnaire for families(10 weeks)

Study Sites (1)

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