Back to resultsConstraint Induced Movement Therapy on Infantile Hemiplegia
Primary Purpose
Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
mCIMT
Unimanual therapy without constraint UTWC
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia focused on measuring Upper extremity, Physical therapy modalities
Eligibility Criteria
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.
Sites / Locations
- San Pablo CEU University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
UTWC (control group)
mCIMT
Arm Description
the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment.
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.
Outcomes
Primary Outcome Measures
Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.
Change from baseline on the Shuee Evaluation at week 5
Secondary Outcome Measures
Change from baseline on visual-motor coordination at week 5.
Circuit described by Mak in 2010
Change from baseline on Grip strength at week 5.
Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02178371
Brief Title
Constraint Induced Movement Therapy on Infantile Hemiplegia
Official Title
Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEU San Pablo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Upper extremity, Physical therapy modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UTWC (control group)
Arm Type
Experimental
Arm Description
the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment.
Arm Title
mCIMT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
mCIMT
Other Intervention Name(s)
Modified constraint-induced movement therapy
Intervention Description
affected upper limb use with constraint of the healthy hand
Intervention Type
Procedure
Intervention Name(s)
Unimanual therapy without constraint UTWC
Intervention Description
affected upper limb use without constraint of healthy hand
Primary Outcome Measure Information:
Title
Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.
Time Frame
Baseline, week 5.
Title
Change from baseline on the Shuee Evaluation at week 5
Time Frame
baseline, week 5
Secondary Outcome Measure Information:
Title
Change from baseline on visual-motor coordination at week 5.
Description
Circuit described by Mak in 2010
Time Frame
Baseline, week 5.
Title
Change from baseline on Grip strength at week 5.
Time Frame
Baseline, week 5.
Title
Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.
Time Frame
Baseline, week 5.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocio Palomo Carrión, PhD, PT
Organizational Affiliation
San Pablo CEU University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco García-Muro SAn José, PhD, PT
Organizational Affiliation
San Pablo CEU University
Official's Role
Study Director
Facility Information:
Facility Name
San Pablo CEU University
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28668
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Constraint Induced Movement Therapy on Infantile Hemiplegia
We'll reach out to this number within 24 hrs