Constraint Induced Movement Therapy on Infantile Hemiplegia

NCT02178371 | Completed

• 1 other identifier: CEU-006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia

Keywords

Upper extremity; Physical therapy modalities

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from baseline on visual-motor coordination at week 5.

  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.

Study Arms (2)

UTWC (control group)

EXPERIMENTAL

the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment.

Procedure: Unimanual therapy without constraint UTWC

mCIMT

EXPERIMENTAL

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

Interventions

mCIMT PROCEDURE

affected upper limb use with constraint of the healthy hand

Also known as: Modified constraint-induced movement therapy

mCIMT

Unimanual therapy without constraint UTWC PROCEDURE

affected upper limb use without constraint of healthy hand

UTWC (control group)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (1)

San Pablo CEU University

Boadilla del Monte, Madrid, 28668, Spain

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rocio Palomo Carrión, PhD, PT

  San Pablo CEU University

  PRINCIPAL INVESTIGATOR

• Francisco García-Muro SAn José, PhD, PT

  San Pablo CEU University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

ES (1)