Constraint Induced Movement Therapy on Infantile Hemiplegia

Not Applicable

Completed

• Conditions: Hemiplegia
• Interventions: Procedure: Unimanual therapy without constraint UTWC; Procedure: mCIMT

• Registration Number: NCT02178371
• Lead Sponsor: CEU San Pablo University

Brief Summary

The purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Study Start: 2015-01
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Children's Hemiplegia Medical diagnosis.
• Aged between 4 and 8 years.
• Lack of activity of the affected upper extremity.
• Overcoming 10th extension at the metacarpophalangeal and interphalangeal joint.
• Complete the 20 º of wrist extension of the affected upper extremity.
• Adequate cognitive development to understand verbal commands given for the execution of tasks.
• Cooperation in the execution of tasks.

Exclusion Criteria

• To Have vision problems that prevent them from carrying out the intervention.
• Having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb.
• Submit uncontrolled seizures.
• To Have received botulinum toxin prior to 6 months prior to the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UTWC (control group)	Unimanual therapy without constraint UTWC	the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment.
mCIMT	mCIMT	The study is conducted over a period of 5 weeks of treatment, using a movement restriction time healthy upper extremity of 2 hours daily. The restriction applied in the study is performed with the closed hand position and thumb inside the fist through a transparent film that reaches the wrist joint. In periods mCIMT, monitored the activities designed to enhance their functionality, based on motivation, avoiding frustrations are made.

Primary Outcome Measures

Name	Time	Method
Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.	Baseline, week 5.
Change from baseline on the Shuee Evaluation at week 5	baseline, week 5

Secondary Outcome Measures

Name	Time	Method
Change from baseline on visual-motor coordination at week 5.	Baseline, week 5.	Circuit described by Mak in 2010
Change from baseline on Grip strength at week 5.	Baseline, week 5.
Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.	Baseline, week 5.

Trial Locations

Locations (1)

San Pablo CEU University; 🇪🇸 Boadilla del Monte, Madrid, Spain