Constraint Induced Movement Therapy on Infantile Hemiplegia

Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia
• Intervention / Treatment: Procedure: Unimanual therapy without constraint UTWC; Procedure: mCIMT

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Boadilla del Monte, Madrid, Spain, 28668
      • San Pablo CEU University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UTWC (control group); the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment.	Procedure: Unimanual therapy without constraint UTWC; affected upper limb use without constraint of healthy hand
Experimental: 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.	Procedure: mCIMT; affected upper limb use with constraint of the healthy hand; Other Names: Modified constraint-induced movement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Change from baseline on visual-motor coordination at week 5.	Circuit described by Mak in 2010	Baseline, week 5.
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.

Collaborators and Investigators

• Sponsor: CEU San Pablo University
• Investigators: Principal Investigator: Rocio Palomo Carrión, PhD, PT, San Pablo CEU University; Study Director: Francisco García-Muro SAn José, PhD, PT, San Pablo CEU University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Upper extremity; Physical therapy modalities
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: CEU-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No