Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

Upper Extremity Paresis Clinical Trial

Official title:

Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642872
• Other study ID #: infant CIMT/BIT
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: November 2020
• Source: CEU San Pablo University
• Contact: Rocío Palomo Carrión
• Phone: 606417213
• Email: rociopalomotoledo[@]gmail.com
• Is FDA regulated: No
• 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 familes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 20, 2021
• Est. primary completion date: January 18, 2021
• 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 medicins
• No collaborated families

Related Conditions & MeSH terms

• Bimanual Intensive Therapy
• Cerebral Palsy
• Constraint Induced Movement Therapy
• Family
• Hemiplegia
• Infantile Hemiplegia
• Paresis
• Upper Extremity Paresis

Intervention

Other:
• Infant BIT
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
• Infant CIMT/BIT
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
• Conventional therapy
Following the usual therapy in the baby.
• infant cimt
use of unaffected hand containment to improve the use of affected hand with unimanual activities

Locations

Country	Name	City	State
Spain	Hemiweb	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
CEU San Pablo University

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 familes	Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.	10 weeks