Movement in the Non-use of the Affected Upper Extremity in Children Hemiparesis: Mirror Therapy and Action-observation
Primary Purpose
Hemiplegia, Infantile
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mirror therapy and action-observation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia, Infantile
Eligibility Criteria
Inclusion Criteria:
- Children with hemiparesia.
- From 6 to 12 years,
- A spontaneous use of the hand according to the scale HOUSE, a level MACS I-III
- A good cooperation and cognition
Exclusion Criteria:
- Severe spasticity
- Previous surgery of the upper extremity
- The use of botox
Sites / Locations
- CEU-San Pablo UniverstiyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mirrow therapy and action-observation therapy
Action-observation therapy
Arm Description
The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. The first 15 minutes will include myrror therapy 6 activities and the remaing 45 minutes both unimanual and bimanual action-observation therapy activities.
The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. There protocol includes both unimanual and bimanual action-observation therapy activities.
Outcomes
Primary Outcome Measures
Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale
AHA scale includes several domains: general use, arm use, grasp-release, fine motor adjustments, coordination and rhythm. 22 items are scored and converted to 0-100 logit-based AHA units.
Functionality of the affected hand assess by Jensen-Taylor scale
The Jebsen-Taylor scale includes 7 subtests: writing, card turning, picking up small objects, stacking checkers, stimulated feeding, moving lights objects, moving heavy objects. Normative data are described for adults, but not for children.
Experience of children in the use of the affected hand during activities where two hands are usually required assess by the Children's Hand-use Experience Questionnaire (CHEQ).
The CHEQ questionnaire ask about some activities that typically require the use of both hands. The results are converted into logits using Rasch analysis.
Grip strength assess by hand grip dynamometer
Hand grip dynamometer
Muscular activity of the wrist muscles assess by Surface electromyography (EMG)
Surface EMG
Range of motion of the wrist assess by goniometer and goniometer app
Goniometer and goniometer app
Secondary Outcome Measures
correlation between range of motion of the wrist assessed by goniometer and goniometer app
To assess the correlation of the range of motion evaluated by universal goniometer and goniometer app
Full Information
NCT ID
NCT04284176
First Posted
February 19, 2020
Last Updated
April 16, 2021
Sponsor
CEU San Pablo University
1. Study Identification
Unique Protocol Identification Number
NCT04284176
Brief Title
Movement in the Non-use of the Affected Upper Extremity in Children Hemiparesis: Mirror Therapy and Action-observation
Official Title
Influence of the Quality of Movement in the "Non-use" of the Upper Extremity Affected in Children Hemiparesis: Mirror Therapy and Action-observation as Therapeutic Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEU San Pablo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children with cerebral palsy hemiplegia present a restriction in the daily activities due to the limitation in the active movement of the affected upper extremity.
The mirror therapy (MT) in children with hemiparesis produces an improvement in the quality of movement and in the perception of the affected upper extremity. The action-observation therapy (AOT) favors the motor behaviour of the affected upper extremity through the observation of sequences of systematic activities and their posterior execution. It also produces an increase in the excitability of the corticospinal tract, originating muscular pattern contraction similar to the observed ones and favoring the motor activity.
The combination of both therapies might improve the quality of movement of the upper extremity and provide a major cortical activation and increase the spontaneous use on having created the only protocol of intervention which includes the benefits of both interventions.
The principal aim of this study is to analyze the influence of the quality of movement in the spontaneous use of the upper extremity affected in children with hemiparesis as well as the improvement of both variables across MTAO. Another specific aim will be to determine if "the non-use" is determined by the quality of the movement of the segment, if the MTAO reduces "the non-use" of this extremity as well as to obtain a protocol of intervention that increases the quality of movement and the spontaneous long-term use.
A randomized controlled trial will be carry out in children with hemiparesia between 6 and 12 years, with a spontaneous use of the hand according to the scale HOUSE, a level Manual Ability Classification System (MASC) I-III and a good cooperation and cognition. Those with a severe spasticity, previous surgery of the upper extremity and the use of botox will be excluded. The children will be divided in two groups. The experimental group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the control group will receive 60 minutes of AOT.
Four measurements will be obtained: basal situation, at the end of the treatment and measures of follow-up to 3 and 6 months after the end of the treatment. Despite the sociodemographic variables, measures of the quality of the movement, the spontaneous use of the upper extremity, the questionnaire CHEQ and the AHA scale.
Detailed Description
Two protocols are designed to be carried out at home. The AOT protocol includes 15 set of daily life upper limb uni/bimanual activities (8 sets for bimanual activities and 7 sets for unimanual activities).
The MTAO group include 6 mirror therapy activities and the same activities that are included in the AOT protocol.
A pilot study will be conducted for sample size calculation, assessing the AHA and Jebsen-Taylor scales, before and immediately after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Infantile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirrow therapy and action-observation therapy
Arm Type
Experimental
Arm Description
The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. The first 15 minutes will include myrror therapy 6 activities and the remaing 45 minutes both unimanual and bimanual action-observation therapy activities.
Arm Title
Action-observation therapy
Arm Type
Experimental
Arm Description
The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. There protocol includes both unimanual and bimanual action-observation therapy activities.
Intervention Type
Other
Intervention Name(s)
Mirror therapy and action-observation therapy
Intervention Description
The mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT.
Primary Outcome Measure Information:
Title
Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale
Description
AHA scale includes several domains: general use, arm use, grasp-release, fine motor adjustments, coordination and rhythm. 22 items are scored and converted to 0-100 logit-based AHA units.
Time Frame
6 months
Title
Functionality of the affected hand assess by Jensen-Taylor scale
Description
The Jebsen-Taylor scale includes 7 subtests: writing, card turning, picking up small objects, stacking checkers, stimulated feeding, moving lights objects, moving heavy objects. Normative data are described for adults, but not for children.
Time Frame
6 months
Title
Experience of children in the use of the affected hand during activities where two hands are usually required assess by the Children's Hand-use Experience Questionnaire (CHEQ).
Description
The CHEQ questionnaire ask about some activities that typically require the use of both hands. The results are converted into logits using Rasch analysis.
Time Frame
6 months
Title
Grip strength assess by hand grip dynamometer
Description
Hand grip dynamometer
Time Frame
6 months
Title
Muscular activity of the wrist muscles assess by Surface electromyography (EMG)
Description
Surface EMG
Time Frame
6 months
Title
Range of motion of the wrist assess by goniometer and goniometer app
Description
Goniometer and goniometer app
Time Frame
6 months
Secondary Outcome Measure Information:
Title
correlation between range of motion of the wrist assessed by goniometer and goniometer app
Description
To assess the correlation of the range of motion evaluated by universal goniometer and goniometer app
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with hemiparesia.
From 6 to 12 years,
A spontaneous use of the hand according to the scale HOUSE, a level MACS I-III
A good cooperation and cognition
Exclusion Criteria:
Severe spasticity
Previous surgery of the upper extremity
The use of botox
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan-Carlos Zuil-Escobar, PhD
Phone
+34616442143
Email
jczuil@ceu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan-Carlos Zuil-Escobar, PhD
Organizational Affiliation
CEU San Pablo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEU-San Pablo Universtiy
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Zuil-Escobar, PhD
Phone
913724700
Email
jczuil@ceu.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Movement in the Non-use of the Affected Upper Extremity in Children Hemiparesis: Mirror Therapy and Action-observation
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