Clinical trial NCT04802655: Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality
Official title: Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase randomized controlled trial has planned to conduct. In the first phase, baseline assessments will be completed for all participants who are eligible to participate. After the baseline assessments, randomisation will be completed for Exergame and Activity Based Exercise groups. During this phase suitable video games for exergame program will be selected. Analytical Hierarchy Process (AHP) will be used to collect expert opinion for most effective video games for upper extremity functionality, postural control, GMFCS I-II-III levels. Second phase of the study will be started afterwards. Upon completing second assessments, interventions for both groups will be conducted. Third assessments will be completed after interventions and outcomes will be analyzed for primary results. The third phase of the study planned as follow-up period. All participant will continue their routine NDT trainings and follow-up assessments will be completed after 3 moths of the second assessments. Final results will be analysed for all participants.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with spastic cerebral palsy
* Gross Motor Level should be in between I-III according to Gross Motor Function Classification System (GMFCS)
* Manual ability levels should be in between I-IV according to Manual Abilities Classification System (MACS)
* No Botulinum toxin injections 6 months prior to study

Exclusion Criteria:

* Surgery history related to the musculoskeletal system (upper and lower extremities)
* Having communication problems
* Having secondary cognitive-behavioral problems addition to cerebral palsy (intellectual disability)

Primary outcomes:
measure: Upper Limb Kinematics - Range of Motion Analysis
timeFrame: 10 minutes
measure: Upper Limb Kinematics - Angular velocity
timeFrame: 10 minutes
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: 15 minutes
Secondary outcomes:
measure: Selective Control of Upper Extremity Scale (SCUES)
timeFrame: 15 minutes
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: 10 minutes
measure: Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Ahmet Emir, Msc
role: PRINCIPAL_INVESTIGATOR
References: