Modified Constraint-Induced Movement Therapy in Children With Hemiparetic Cerebral Palsy
Primary Purpose
Spastic Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Consecutive Modified Constraint-Induced Movement Therapy
Traditional physiotherapy
Intermittent Modified Constraint-Induced Movement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Hemiplegic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- confirmed diagnosis of hemiplegic CP
- 5-18 years of age
- MACS level I, II or III
- GMFCS level I
- To have sufficient communication skills
- To be able to extend the wrist at least 20 degrees
- Lack of severe spasticity to prevent grasping and dropping objects
- Surgery or application of Botulinum toxin within the last 6 months
- The family's acceptance of the child's participation in the study
- The child volunteers to participate in the study
Exclusion Criteria:
- Visual and hearing impairment
- Family refuses to participate in the study
- There is a walking and balance problem that may cause a fall risk during the use of a sling
- Behavioral problems at the level to reject the practices to be performed within the study
Sites / Locations
- Abant Izzet Baysal University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Consecutive mCIMT group
Intermittent mCIMT group
Traditional physiotherapy control group
Arm Description
6 hours / day, 10 consecutive days, 60 hours mKZHT + 2 days 45 minutes / day traditional physiotherapy
6 hours / day 2 days a week 5 weeks, a total of 60 hours mKZHT + 2 days 45 min / day traditional physiotherapy
45 min / day, 2 days a week traditional physiotherapy
Outcomes
Primary Outcome Measures
Children's Hand-Use Experience Questionnaire (CHEQ)
Assessing children's experience of using the affected hand in activities of daily living where usually two hands are needed. There are 29 items at questionnaire. When respondents answered the questionnaire, they were first asked whether the activity included in the questionnaire was conducted independently. If the activities can be done independently, it is questioned whether one or two hands are used during the activities. If two hands are used, answers and scores to the following 3 sub-questions are sought: hand use, time use in comparison to peers, experience of feeling bothered while doing the activity. A higher score indicates a better level of independence.
Jebsen-Taylor Hand Function Test
This is an objective test to evaluate hand function for a person's activities of daily living. Test consist of 7 subtests includes writing, card turning, manipulate small common objects, simulated feeding, stacking checkers, moving large light objects and moving large heavy objects. We will use 6 subtests except writing in our study.
Secondary Outcome Measures
Gross Motor Classification System (GMFCS)
This is a classification system for children with chronic disability and based on the movements initiated by the child him/herself such as sitting, moving and acting. GMFCS classifies gross motor functions of children with CP in five levels.
Manual Ability Classification System (MACS)
MACS is a five-level classification system that analyzes the children with CP use their hands while carrying objects in their daily activities.
Pediatric Balance Scale (PBS)
Assesses children's balance and consist of 14 items. Each item is scored between 0 and 4 points. Low score refers to the poor balance and the high score refers to the good balance.
Modified Tardieu Scale (MTS)
The scale was developed to evaluate spasticity. This scale reveals the rate-dependent nature of spasticity (27). Muscle reaction quality (X) and muscle reaction angle (Y) are determined with MTS. When measuring the muscle reaction angle, the goniometer is used to measure the position of the muscle with minimum stretching. If quality of muscle reaction score was 2 or higher, the joint angle in which the muscle responds with difficulty will be measured goniometer. The scales scores range from 0 to 5. 0= no resistance to passive movement. 1= slight resistance throughout the course of the passive movement. 2= there's a clear catching at a precise angle, which makes passive movement difficult, followed by a release. 3= fatigable clonus (Less than 10 seconds). 4= infatigable clonus (More than 10 seconds). 5= the joint cannot be moved. Evaluations are made in thre
ABILHAND-Kids Questionnaire
Evaluates manual ability in children with cerebral palsy. Questionnaire consist of 21 bimanual items. Each item graded three levels (0=impossible, 1= difficult, 2= easy) and lower scores indicate lower ability of the hand or upper extremity.
Surface electromyography (sEMG)
sEMG evaluates electrical activity of muscle groups. It is a non-invasive method used to evaluate muscle activation. Delsys Trigno Wireless System device will be used for measurements. Measurements using silver-silver chloride (Ag-AgCl) disposable adhesive electrodes will be performed in accordance with the criteria of SENIAM (surface EMG for non-invasive assessment of muscle) and literature.
Pediatric Evaluation of Disability Inventory (PEDI)
PEDI evaluates disability, activity and participation in pediatric population. It consist of 197 items and each item scored in the way 0: can not do, 1: can do.
Full Information
NCT ID
NCT04064788
First Posted
August 20, 2019
Last Updated
February 11, 2021
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT04064788
Brief Title
Modified Constraint-Induced Movement Therapy in Children With Hemiparetic Cerebral Palsy
Official Title
The Effect of the Modified Constraint-Induced Movement Therapy Administered on Consecutive or Intermittent Days on Upper Extremity Function in Individuals With Hemiparetic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
January 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cerebral palsy (CP) is defined as a non-progressive lesion of the developing foetal or infant brain and causes variety of motor, sensory and cognitive impairments. Hemiplegic CP is the most common type of CP in term infants, involving one half of the body. In these individuals, muscle tone is reduced, and there is an inability to perform quality upper extremity movements due to increased muscle tone, increased reflexes, weakness in antagonist muscles. Due to spasticity upper extremity is present in shoulder adduction and internal rotation, elbow flexion and pronation, wrist and fingers flexed and thumb in palm position. Spontaneous movements of the upper extremity are decreased and abnormal. These individuals have a reduced upper extremity function ranging from mild incompetence to almost no use of the hand.
Constraint-Induced Movement Therapy (CIMT) is designed to improve the function of the most affected limb by restricting the use of the less affected limb in individuals with unilateral upper extremity involvement and implementing an intensive motor learning-based training program. In pediatric subjects, modified CIMT (mCIMT), which is called a 'child-friendly technique', has been applied, which shows some differences from the form of CIMT in adults. In mCIMT, the restriction time was reduced, activities with the child were performed within a play frame, in the environment in which the child was accustomed, and restriction methods such as gloves, splint, sling were used. In the literature CIMT has been used mainly in children with hemiplegic CP in the pediatric population. However, there are many studies in the literature evaluating the efficacy of mCIMT in individuals with hemiplegic CP and showing beneficial effects on upper extremity speed and skills, and the duration of application restriction varies considerably.
The aim of the investigator's study was to determine the effect of consecutive or intermittent implementation of mCIMT on upper extremity function in children with hemiplegic CP. Thus, it will be determined whether the modification of the duration of administration in the pediatric population varies in treatment results.
Detailed Description
33 children with spastic hemiplegia age between 5-18 years will participate study. Children's gross motor skills classified with Gross Motor Classification Sysytem (GMFCS) and hand abilities classified with Manual Ability Classification System (MACS). The children divided into 3 groups, consecutive mCIMT group, intermittent mCIMT group, and traditional physiotherapy control group. The consecutive mCIMT group received mCIMT treatment for 10 consecutive days in addition to the conventional physiotherapy sessions. A sling used to restrict the noninvolved upper extremity. The unaffected upper extremities of the children restricted for 6 hours and activities performed by using shaping techniques under the guidance of same therapist. Within the remaining period, the family implemented the activities with his/her child that are determined by the therapist using the motor learning principles, appropriate to the age of the child and that he / she likes to do. The assessments performed for all three groups before, 10 days after and 5 weeks after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Consecutive mCIMT group
Arm Type
Experimental
Arm Description
6 hours / day, 10 consecutive days, 60 hours mKZHT + 2 days 45 minutes / day traditional physiotherapy
Arm Title
Intermittent mCIMT group
Arm Type
Experimental
Arm Description
6 hours / day 2 days a week 5 weeks, a total of 60 hours mKZHT + 2 days 45 min / day traditional physiotherapy
Arm Title
Traditional physiotherapy control group
Arm Type
Active Comparator
Arm Description
45 min / day, 2 days a week traditional physiotherapy
Intervention Type
Other
Intervention Name(s)
Consecutive Modified Constraint-Induced Movement Therapy
Intervention Description
Consecutive mCIMT group received 6 hours per day mCIMT sessions for consecutive 10 days. Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.
Intervention Type
Other
Intervention Name(s)
Traditional physiotherapy
Intervention Description
Traditional physiotherapy within a specific program
Intervention Type
Other
Intervention Name(s)
Intermittent Modified Constraint-Induced Movement Therapy
Intervention Description
Intermittent mCIMT group received mCIMT session 6 hours per day for 10 days, spread over 5 weeks (two days per week). Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.
Primary Outcome Measure Information:
Title
Children's Hand-Use Experience Questionnaire (CHEQ)
Description
Assessing children's experience of using the affected hand in activities of daily living where usually two hands are needed. There are 29 items at questionnaire. When respondents answered the questionnaire, they were first asked whether the activity included in the questionnaire was conducted independently. If the activities can be done independently, it is questioned whether one or two hands are used during the activities. If two hands are used, answers and scores to the following 3 sub-questions are sought: hand use, time use in comparison to peers, experience of feeling bothered while doing the activity. A higher score indicates a better level of independence.
Time Frame
Change from Baseline at 10 days and at 5 weeks
Title
Jebsen-Taylor Hand Function Test
Description
This is an objective test to evaluate hand function for a person's activities of daily living. Test consist of 7 subtests includes writing, card turning, manipulate small common objects, simulated feeding, stacking checkers, moving large light objects and moving large heavy objects. We will use 6 subtests except writing in our study.
Time Frame
Change from Baseline at 10 days and at 5 weeks
Secondary Outcome Measure Information:
Title
Gross Motor Classification System (GMFCS)
Description
This is a classification system for children with chronic disability and based on the movements initiated by the child him/herself such as sitting, moving and acting. GMFCS classifies gross motor functions of children with CP in five levels.
Time Frame
At Baseline
Title
Manual Ability Classification System (MACS)
Description
MACS is a five-level classification system that analyzes the children with CP use their hands while carrying objects in their daily activities.
Time Frame
At Baseline
Title
Pediatric Balance Scale (PBS)
Description
Assesses children's balance and consist of 14 items. Each item is scored between 0 and 4 points. Low score refers to the poor balance and the high score refers to the good balance.
Time Frame
At Baseline
Title
Modified Tardieu Scale (MTS)
Description
The scale was developed to evaluate spasticity. This scale reveals the rate-dependent nature of spasticity (27). Muscle reaction quality (X) and muscle reaction angle (Y) are determined with MTS. When measuring the muscle reaction angle, the goniometer is used to measure the position of the muscle with minimum stretching. If quality of muscle reaction score was 2 or higher, the joint angle in which the muscle responds with difficulty will be measured goniometer. The scales scores range from 0 to 5. 0= no resistance to passive movement. 1= slight resistance throughout the course of the passive movement. 2= there's a clear catching at a precise angle, which makes passive movement difficult, followed by a release. 3= fatigable clonus (Less than 10 seconds). 4= infatigable clonus (More than 10 seconds). 5= the joint cannot be moved. Evaluations are made in thre
Time Frame
Change from Baseline at 10 days and at 5 weeks
Title
ABILHAND-Kids Questionnaire
Description
Evaluates manual ability in children with cerebral palsy. Questionnaire consist of 21 bimanual items. Each item graded three levels (0=impossible, 1= difficult, 2= easy) and lower scores indicate lower ability of the hand or upper extremity.
Time Frame
Change from Baseline at 10 days and at 5 weeks
Title
Surface electromyography (sEMG)
Description
sEMG evaluates electrical activity of muscle groups. It is a non-invasive method used to evaluate muscle activation. Delsys Trigno Wireless System device will be used for measurements. Measurements using silver-silver chloride (Ag-AgCl) disposable adhesive electrodes will be performed in accordance with the criteria of SENIAM (surface EMG for non-invasive assessment of muscle) and literature.
Time Frame
Change from Baseline at 10 days and at 5 weeks
Title
Pediatric Evaluation of Disability Inventory (PEDI)
Description
PEDI evaluates disability, activity and participation in pediatric population. It consist of 197 items and each item scored in the way 0: can not do, 1: can do.
Time Frame
Change from Baseline at 10 days and at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed diagnosis of hemiplegic CP
5-18 years of age
MACS level I, II or III
GMFCS level I
To have sufficient communication skills
To be able to extend the wrist at least 20 degrees
Lack of severe spasticity to prevent grasping and dropping objects
Surgery or application of Botulinum toxin within the last 6 months
The family's acceptance of the child's participation in the study
The child volunteers to participate in the study
Exclusion Criteria:
Visual and hearing impairment
Family refuses to participate in the study
There is a walking and balance problem that may cause a fall risk during the use of a sling
Behavioral problems at the level to reject the practices to be performed within the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Çankaya
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sezen Tezcan
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14280
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
14754942
Citation
Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics. 2004 Feb;113(2):305-12. doi: 10.1542/peds.113.2.305.
Results Reference
background
PubMed Identifier
19489088
Citation
Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
Results Reference
background
PubMed Identifier
17443542
Citation
Hoare BJ, Wasiak J, Imms C, Carey L. Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004149. doi: 10.1002/14651858.CD004149.pub2.
Results Reference
background
PubMed Identifier
19339749
Citation
Stearns GE, Burtner P, Keenan KM, Qualls C, Phillips J. Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. NeuroRehabilitation. 2009;24(2):95-108. doi: 10.3233/NRE-2009-0459.
Results Reference
background
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Modified Constraint-Induced Movement Therapy in Children With Hemiparetic Cerebral Palsy
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