Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis

Not Applicable

Completed

• Conditions: Family; Bimanual Intensive Therapy; Infantile Hemiplegia; Constraint Induced Movement Therapy
• Interventions: Procedure: INFANT CIMT/BIT

• Registration Number: NCT06191588
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study Start: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2024-03
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-20
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant CIMT/BIT	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
infant cimt	INFANT CIMT/BIT	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.
Conventional Therapy	INFANT CIMT/BIT	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
Infant BIT	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

Primary Outcome Measures

Name	Time	Method
mini Assisting Hand Assesment	10 weeks	Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.

Secondary Outcome Measures

Name	Time	Method
Satisfaction questionnaire for families	10 weeks	Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.

Trial Locations

Locations (1)

Elena Piñero Pinto; 🇪🇸 Seville, Spain