Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality

NCT ID: NCT04802655

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2023-07-15

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exergame Group (EG)

In addition to routine NDT training, Structured Exergame Program for upper extremity and trunk control will be applied in this group. Xbox one - Kinect supported video games will be selected for video-game based exergame program. The Video games to be included in the Exergame program will be selected by Analytical Hierarchy Process. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks.

Group Type: EXPERIMENTAL

Video-game based exercise - Exergame

Intervention Type: OTHER

Selected Kinect compatible video games from Microsoft Xbox one will be applied in this group. Four video games will be selected for a session (each game will last 10 mins). Video games are active video games which participants have to use their body parts in order to control games.

Activity Based Exercise Group (AG)

In addition to routine NDT training, Goal Directed Activity Based Exercises for upper extremity and trunk will be applied to this group. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks.

Group Type: ACTIVE_COMPARATOR

Activity Based Exercise Group (AG)

Intervention Type: OTHER

Task-oriented exercises to be performed in standing and sitting positions, including upper extremity and trunk, will be applied to the activity-based exercise group in addition to routine NDT training. Examples for activities; stepping and putting stickers on the wall, treading the play dough placed on a step board within one leg stance; reach-grasp activities progressively from sitting to standing, throwing and catching balls on a balance board.

Interventions

Video-game based exercise - Exergame

Selected Kinect compatible video games from Microsoft Xbox one will be applied in this group. Four video games will be selected for a session (each game will last 10 mins). Video games are active video games which participants have to use their body parts in order to control games.

Intervention Type: OTHER

Activity Based Exercise Group (AG)

Task-oriented exercises to be performed in standing and sitting positions, including upper extremity and trunk, will be applied to the activity-based exercise group in addition to routine NDT training. Examples for activities; stepping and putting stickers on the wall, treading the play dough placed on a step board within one leg stance; reach-grasp activities progressively from sitting to standing, throwing and catching balls on a balance board.

Intervention Type: OTHER

Other Intervention Names

Microsoft Xbox One Kinect based exergame program; Goal Directed Upper Limb and Postural Control Exercises

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmet Emir

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Emir

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmet Emir, Msc

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-65173

Identifier Type: -

Identifier Source: org_study_id