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Completed

NCT Number: NCT02178371

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.

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Key information

Conditions

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

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Pablo CEU University

Boadilla del Monte, Madrid, 28668, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mCIMT

Procedure

affected upper limb use with constraint of the healthy hand

Other names: Modified constraint-induced movement therapy

Unimanual therapy without constraint UTWC

Procedure

affected upper limb use without constraint of healthy hand

Primary outcomes

  1. Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.

    Time frame: Baseline, week 5.

  2. Change from baseline on the Shuee Evaluation at week 5

    Time frame: baseline, week 5

Secondary outcomes

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

    Time frame: Baseline, week 5.

    Circuit described by Mak in 2010

  2. Change from baseline on Grip strength at week 5.

    Time frame: Baseline, week 5.

  3. Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.

    Time frame: Baseline, week 5.

Sponsors and collaborators

Lead sponsor

CEU San Pablo University

Other

Registry information

Official study title

Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 30, 2014
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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