Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

Sponsor

CEU San Pablo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04642872

Collaborator

(none)

Enrollment

Location

Arms

19.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 familes.

Condition or Disease	Intervention/Treatment	Phase
Infantile Hemiplegia Upper Extremity Paresis Family Constraint Induced Movement Therapy Bimanual Intensive Therapy	Other: Infant BIT Other: Infant CIMT/BIT Other: Conventional therapy Other: infant cimt	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2019

Anticipated Primary Completion Date :

Jan 18, 2021

Anticipated Study Completion Date :

Mar 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: infant cimt	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.
Active Comparator: Infant 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
Active Comparator: Infant CIMT/BIT	Other: Infant BIT Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination 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
Active Comparator: Conventional Therapy	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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hemiweb	Barcelona		Spain

Sponsors and Collaborators

CEU San Pablo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rocio Palomo Carrión, Director, CEU San Pablo University

ClinicalTrials.gov Identifier:

NCT04642872

Other Study ID Numbers:

infant CIMT/BIT

First Posted:

Nov 24, 2020

Last Update Posted:

Nov 24, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Palsy

Hemiplegia

Paresis

Study Results

No Results Posted as of Nov 24, 2020