Constraint Induced Movement Therapy on Infantile Hemiplegia

Hemiplegia Clinical Trial

Official title:

Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178371
• Other study ID #: CEU-006
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: CEU San Pablo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Procedure:
• mCIMT
affected upper limb use with constraint of the healthy hand
• Unimanual therapy without constraint UTWC
affected upper limb use without constraint of healthy hand

Locations

Country	Name	City	State
Spain	San Pablo CEU University	Boadilla del Monte	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
CEU San Pablo University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.		Baseline, week 5.
Primary	Change from baseline on the Shuee Evaluation at week 5		baseline, week 5
Secondary	Change from baseline on visual-motor coordination at week 5.	Circuit described by Mak in 2010	Baseline, week 5.
Secondary	Change from baseline on Grip strength at week 5.		Baseline, week 5.
Secondary	Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.		Baseline, week 5.