Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy, Mirror Movement Therapy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mirror Therapy
Program without Mirror Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring unilateral spastic cerebral palsy, mirror therapy, bimanual performance, somatosensory function, quality of life
Eligibility Criteria
Inclusion Criteria:
- To have been diagnosed with Unilateral Spastic Cerebral Palsy.
- To be capable of following and understanding rules.
Exclusion Criteria:
- To have had surgical interventions, botulinum toxin or shock waves 3 months before the study;
- To be receiving intensive therapies on the upper limb;
- To have attentional or behavioural difficulties;
- To have moderate to high intellectual disability;
- To have non-treated epilepsy;
- To have non-corrected visual problems
Sites / Locations
- Fundació Aspace Catalunya
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week.
The control group will perform a 5-week motor program consisting of 4 bimanual exercises without mirror therapy, to be done at home 30 minutes a day, 5 days a week.
Outcomes
Primary Outcome Measures
Change in Bimanual Performance
How Bimanual Performance, assessed with Children's Hand-use Experience Questionnaire, changes by doing the intervention
Secondary Outcome Measures
Change in Tactile Registration of the impaired hand.
An evaluation to determine whether the impaired hand is capable of identifying a somatosensory stimuli. The index pad is stimulated with the Semmes Weinstein Monofilament, starting with the largest monofilament considered as "normal sensation. 3 correct identifications are considered as a correct answer, with the smallest monofilament possible.
Change in static two-point discrimination of the impaired hand.
An evaluation to determine the shortest distance that the impaired hand is capable of identifying to simultaneous stimuli.The index pad is stimulated with the Disk-Criminator, that applies two simultaneous stimuly. The shortest distance at which the patient is capable of idenitfying both stimuli 7/10 times is considered as a correct answer.
Change in moving two-point discrimination of the impaired hand.
An evaluation to determine the shortest distance that the impaired hand is capable of identifying to moving simultaneous stimuli.The index pad is stimulated with the Disk-Criminator, that applies two simultaneous stimuly, with small circular movement. The shortest distance at which the patient is capable of idenitfying both stimuli 7/10 times is considered as a correct answer.
Change in single point localisation of the impaired hand.
An evaluation to determine both the capacity of the patient to identify a threshold stimuly applied to thumb, index, 4th and 5th finger of the impaired hand, and the position where stimuli is applied (front, back or side). 12 different stimulations are applied, and the correct answers are the final punctuation.
Change in double simultaneous of the impaired hand.
An evaluation to determine the capacity of the patient to identify a threshold stimuly applied to thumb, index, 4th and 5th finger of the impaired hand, and on the same fingers of the other hand, single and combined. 24 different stimulations are applied, and the correct answers are the final punctuation.
Change in sterognosis of the impaired hand.
An evaluation to determine the capacity of the patient to identify 9 different objects (pen, pencil, button, coin, safety pin, paper clip, key, peg and spoon) placed on the impaired hand, without visual feedback. The final punctuation is for the correct identifications.
Self-reported Quality of Life
How the self-perceived quality of life, assessed with Pediatric Quality of Life Inventory (PEDSQL - CP Module), changes by performing the intervention. The evaluation consists of gradinf (from 0 - never; to 4 - always), how have different situations caused trouble or impairment to children. The presented situations are related to daily activities, movement, pain, school activities, comunication, feeding and fatigue.
Full Information
NCT ID
NCT05244083
First Posted
January 7, 2022
Last Updated
May 21, 2023
Sponsor
Universitat Internacional de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT05244083
Brief Title
Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy
Official Title
Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy: A Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
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
Background: Unilateral Spastic Cerebral Palsy (USPC) is caused by an injury in one brain hemisphere in the immature brain, and affects the contralateral side of the body, especially on the upper limb. It induces motor and somatosensory damages, that are closely related to the hand function. Evidence posits mirror therapy to be a therapy with potential effects on bimanual performance and somatosensory function, that may influence on quality of life. The aim of this study is to demonstrate the effectiveness of a motor program with mirror therapy in children with USCP in the improvement of the bimanual performance, the somatosensory function and quality of life compared with the same program without mirror.
Methods: This study is a Randomised Clinical Trial. The participants are children with USCP aged between 8 and 12 years old classified in levels I and II in Manual Ability Classification System, recruited from Fundació Aspace Catalunya. The eligibility criteria are a) to not have had surgical interventions, botulinum toxin or shock waves 3 months before the study; b) to not be receiving intensive therapies on the upper limb; c) to not have attentional or behavioural difficulties; d) to not have moderate to high intellectual disability; e) to not have non-treated epilepsy; and f) to not have non-corrected visual problems. A total of 22 participants will be recruited for this study, and will be randomised in two groups: control and experimental, through the opaque envelope technique. The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week, while the control group will perform the same program without the mirror. The assessments will be done by a blinded evaluator and will include bimanual performance (Children's Hand-use Experience Questionnaire), somatosensory function and quality of life (PedsQL™), and will be performed at the beginning, at the end of the intervention and 1-month follow-up.
Discussion: Favourably results in this study may imply the implementation of a low-cost therapy, suitable to be done at home, and with no contraindications for children with USCP. Moreover, the suitability to be adapted and performed at home could increase the family implication and empowerment, increasing its confidence in the disability process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy, Mirror Movement Therapy
Keywords
unilateral spastic cerebral palsy, mirror therapy, bimanual performance, somatosensory function, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will perform a 5-week motor program consisting of 4 bimanual exercises without mirror therapy, to be done at home 30 minutes a day, 5 days a week.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
Therapy consisting of perfoming bimanual activities with a mirror placed on the patient's sagital plane, so it creates the brain illusion that the impaired limb moves the same way and quality that the unimpaired does.
Intervention Type
Other
Intervention Name(s)
Program without Mirror Therapy
Intervention Description
Bimanual exercises performed with both upper limbs.
Primary Outcome Measure Information:
Title
Change in Bimanual Performance
Description
How Bimanual Performance, assessed with Children's Hand-use Experience Questionnaire, changes by doing the intervention
Time Frame
Baseline, at 5 weeks and at 9 weeks
Secondary Outcome Measure Information:
Title
Change in Tactile Registration of the impaired hand.
Description
An evaluation to determine whether the impaired hand is capable of identifying a somatosensory stimuli. The index pad is stimulated with the Semmes Weinstein Monofilament, starting with the largest monofilament considered as "normal sensation. 3 correct identifications are considered as a correct answer, with the smallest monofilament possible.
Time Frame
Baseline, at 5 weeks and at 9 weeks
Title
Change in static two-point discrimination of the impaired hand.
Description
An evaluation to determine the shortest distance that the impaired hand is capable of identifying to simultaneous stimuli.The index pad is stimulated with the Disk-Criminator, that applies two simultaneous stimuly. The shortest distance at which the patient is capable of idenitfying both stimuli 7/10 times is considered as a correct answer.
Time Frame
Baseline, at 5 weeks and at 9 weeks
Title
Change in moving two-point discrimination of the impaired hand.
Description
An evaluation to determine the shortest distance that the impaired hand is capable of identifying to moving simultaneous stimuli.The index pad is stimulated with the Disk-Criminator, that applies two simultaneous stimuly, with small circular movement. The shortest distance at which the patient is capable of idenitfying both stimuli 7/10 times is considered as a correct answer.
Time Frame
Baseline, at 5 weeks and at 9 weeks
Title
Change in single point localisation of the impaired hand.
Description
An evaluation to determine both the capacity of the patient to identify a threshold stimuly applied to thumb, index, 4th and 5th finger of the impaired hand, and the position where stimuli is applied (front, back or side). 12 different stimulations are applied, and the correct answers are the final punctuation.
Time Frame
Baseline, at 5 weeks and at 9 weeks
Title
Change in double simultaneous of the impaired hand.
Description
An evaluation to determine the capacity of the patient to identify a threshold stimuly applied to thumb, index, 4th and 5th finger of the impaired hand, and on the same fingers of the other hand, single and combined. 24 different stimulations are applied, and the correct answers are the final punctuation.
Time Frame
Baseline, at 5 weeks and at 9 weeks
Title
Change in sterognosis of the impaired hand.
Description
An evaluation to determine the capacity of the patient to identify 9 different objects (pen, pencil, button, coin, safety pin, paper clip, key, peg and spoon) placed on the impaired hand, without visual feedback. The final punctuation is for the correct identifications.
Time Frame
Baseline, at 5 weeks and at 9 weeks
Title
Self-reported Quality of Life
Description
How the self-perceived quality of life, assessed with Pediatric Quality of Life Inventory (PEDSQL - CP Module), changes by performing the intervention. The evaluation consists of gradinf (from 0 - never; to 4 - always), how have different situations caused trouble or impairment to children. The presented situations are related to daily activities, movement, pain, school activities, comunication, feeding and fatigue.
Time Frame
Baseline, at 5 weeks and at 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To have been diagnosed with Unilateral Spastic Cerebral Palsy.
To be capable of following and understanding rules.
Exclusion Criteria:
To have had surgical interventions, botulinum toxin or shock waves 3 months before the study;
To be receiving intensive therapies on the upper limb;
To have attentional or behavioural difficulties;
To have moderate to high intellectual disability;
To have non-treated epilepsy;
To have non-corrected visual problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA CARITAT BAGUR CALAFAT, PHD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Fundació Aspace Catalunya
City
Barcelona
ZIP/Postal Code
08038
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy
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