Clinical trial NCT04064788: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Hemiplegic Cerebral Palsy
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Children's Hand-Use Experience Questionnaire (CHEQ)
timeFrame: Change from Baseline at 10 days and at 5 weeks
measure: Jebsen-Taylor Hand Function Test
timeFrame: Change from Baseline at 10 days and at 5 weeks
Secondary outcomes:
measure: Gross Motor Classification System (GMFCS)
timeFrame: At Baseline
measure: Manual Ability Classification System (MACS)
timeFrame: At Baseline
measure: Pediatric Balance Scale (PBS)
timeFrame: At Baseline
measure: Modified Tardieu Scale (MTS)
timeFrame: Change from Baseline at 10 days and at 5 weeks
measure: ABILHAND-Kids Questionnaire
timeFrame: Change from Baseline at 10 days and at 5 weeks
measure: Surface electromyography (sEMG)
timeFrame: Change from Baseline at 10 days and at 5 weeks
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: Change from Baseline at 10 days and at 5 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Tamer Çankaya
role: STUDY_DIRECTOR
affiliation: Abant Izzet Baysal University
name: Sezen Tezcan
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.