Clinical trial NCT04425980: The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia
Official title: The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia; Congenital
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability
Primary purpose: TREATMENT

Brief summary: This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy

Detailed description: A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.

During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of congenital hemiplegia,
* Must be able to grasp objects

Exclusion Criteria:

* Cerebral palsy dependent severe emotional difficulties

Primary outcomes:
measure: Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention
timeFrame: From baeline to post-intervention, up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mus
country: Turkey
facility: Mus Alparslan University
state: Muş
Study officials:
affiliation: Muş Alparslan University
name: Hasan Bingöl, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Mintaze Kerem Günel, PhD
role: STUDY_CHAIR
affiliation: Muş Alparslan University
name: Halil ALKAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: