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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04642872
Other study ID # infant CIMT/BIT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
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 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

Study Design


Related Conditions & MeSH terms


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
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