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Clinical Trials/NCT04064788
NCT04064788
Completed
Not Applicable

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

Abant Izzet Baysal University1 site in 1 country33 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spastic Hemiplegic Cerebral Palsy
Sponsor
Abant Izzet Baysal University
Enrollment
33
Locations
1
Primary Endpoint
Jebsen-Taylor Hand Function Test
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
January 8, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sezen Tezcan

Principal Investigator

Abant Izzet Baysal University

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

Outcomes

Primary Outcomes

Jebsen-Taylor Hand Function Test

Time Frame: Change from Baseline at 10 days and at 5 weeks

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.

Children's Hand-Use Experience Questionnaire (CHEQ)

Time Frame: Change from Baseline at 10 days and at 5 weeks

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.

Secondary Outcomes

  • Gross Motor Classification System (GMFCS)(At Baseline)
  • ABILHAND-Kids Questionnaire(Change from Baseline at 10 days and at 5 weeks)
  • Manual Ability Classification System (MACS)(At Baseline)
  • Pediatric Evaluation of Disability Inventory (PEDI)(Change from Baseline at 10 days and at 5 weeks)
  • Pediatric Balance Scale (PBS)(At Baseline)
  • Modified Tardieu Scale (MTS)(Change from Baseline at 10 days and at 5 weeks)
  • Surface electromyography (sEMG)(Change from Baseline at 10 days and at 5 weeks)

Study Sites (1)

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