Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis

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.

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Key information

Conditions

Infantile Hemiplegia Bimanual Intensive Therapy Constraint Induced Movement Therapy Family Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elena Piñero Pinto, Seville, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INFANT CIMT/BIT

Procedure

Constraint induced movement therapy (CIMT) and Bimanual Intensive therapy (BIT)

Other names: Constraint induced movement therapy, Bimanual Intentive Therapy

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

Time frame: 10 weeks

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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jan 5, 2024
Registry last updated: Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed