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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-game based exercise - Exergame
Activity Based Exercise Group (AG)
Sponsored by
Ahmet Emir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exergame Group (EG)

Activity Based Exercise Group (AG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Upper Limb Kinematics - Range of Motion Analysis
Upper limb kinematics analysis for range of motion assessments will be conducted via Kinovea 2D motion analysis software. Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist Range of Motion (ROM) values (in degrees) each pivots will be analyzed afterward.
Upper Limb Kinematics - Angular velocity
Upper limb kinematics analysis for angular velocity will be conducted via Kinovea 2D motion analysis software.Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist angular velocity (mm/s) of each pivots will be analyzed afterward.
Trunk Control Measurement Scale (TCMS)
Trunk Control Measurement Scale (TCMS) is a clinical tool to measure trunk control in children with cerebral palsy. TCMS measures the trunk control in two basic components that are static and dynamic sitting balance. Dynamic sitting balance is divided into two parts as selective movement control and dynamic reaching. The static sitting balance part evaluates trunk control during upper and lower limbs' movements in the sitting position. Balance is assessed during flexion, extension, lateral flexion and rotation movements as selective movements of dynamic sitting. Reaching part of dynamic sitting balance evaluates trunk balance during reaching at different planes. The scale consists of 15 items. Each part has 5,7 and 3 items respectively. Total score ranges between0 and 58 and higher scores reflect better control.

Secondary Outcome Measures

Selective Control of Upper Extremity Scale (SCUES)
The SCUES is a video-based assessment tool evaluating upper extremity joint levels, including the shoulder, elbow, forearm, wrist, and fingers. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). Presence of mirror movements, movement of additional joints, and any motion less than available ROM are scored for movement at each joint level. Considering these four common manifestations of impaired SMC, motion at each of the five joint levels is scored on a four-point scale as: no SMC (0 point), moderately diminished SMC (1 point), mildly diminished SMC (2 point), and normal SMC (3 point). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better SMC.
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT consists of seven unimanual items that are administered using standardized procedures and verbal instructions and performed first with the nondominant hand and then with the dominant hand. The functional tasks on the JTHFT-IT include (a) writing a 24-letter, third-grade reading difficulty sentence; (b) turning 300-500 (7.62 cm by 12.7 cm) cards in simulated page turning; (c) picking up small common objects (including pennies, paper clips, and bottle caps) and placing them in a container; (d) stacking checkers; (e) simulated feeding; and (f) moving light cans and heavier (1 pound) cans. The subtests are scored by recording with a stopwatch the number of seconds required to complete each task.
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
The PEDI-CAT is a comprehensive clinical assessment of functional skills acquired throughout infancy, childhood and adolescence up through the age of 20 years. Each of the four PEDI-CAT domains (daily activities, mobility, social/cognitive and responsibility) is independent and can be used separately or in combination with the other domains. Items in three of the domains focus on the child's ability to perform each functional activity in a manner that is effective given their abilities and challenges. The items in the responsibility domain examine the extent to which responsibility management for complex tasks has been shifted from parent to child. Items do not require the child to perform the activity in a standardized manner for scoring.

Full Information

First Posted
March 15, 2021
Last Updated
October 18, 2023
Sponsor
Ahmet Emir
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1. Study Identification

Unique Protocol Identification Number
NCT04802655
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmet Emir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exergame Group (EG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Activity Based Exercise Group (AG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Video-game based exercise - Exergame
Other Intervention Name(s)
Microsoft Xbox One Kinect based exergame program
Intervention Description
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
Intervention Name(s)
Activity Based Exercise Group (AG)
Other Intervention Name(s)
Goal Directed Upper Limb and Postural Control Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper Limb Kinematics - Range of Motion Analysis
Description
Upper limb kinematics analysis for range of motion assessments will be conducted via Kinovea 2D motion analysis software. Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist Range of Motion (ROM) values (in degrees) each pivots will be analyzed afterward.
Time Frame
10 minutes
Title
Upper Limb Kinematics - Angular velocity
Description
Upper limb kinematics analysis for angular velocity will be conducted via Kinovea 2D motion analysis software.Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist angular velocity (mm/s) of each pivots will be analyzed afterward.
Time Frame
10 minutes
Title
Trunk Control Measurement Scale (TCMS)
Description
Trunk Control Measurement Scale (TCMS) is a clinical tool to measure trunk control in children with cerebral palsy. TCMS measures the trunk control in two basic components that are static and dynamic sitting balance. Dynamic sitting balance is divided into two parts as selective movement control and dynamic reaching. The static sitting balance part evaluates trunk control during upper and lower limbs' movements in the sitting position. Balance is assessed during flexion, extension, lateral flexion and rotation movements as selective movements of dynamic sitting. Reaching part of dynamic sitting balance evaluates trunk balance during reaching at different planes. The scale consists of 15 items. Each part has 5,7 and 3 items respectively. Total score ranges between0 and 58 and higher scores reflect better control.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Selective Control of Upper Extremity Scale (SCUES)
Description
The SCUES is a video-based assessment tool evaluating upper extremity joint levels, including the shoulder, elbow, forearm, wrist, and fingers. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). Presence of mirror movements, movement of additional joints, and any motion less than available ROM are scored for movement at each joint level. Considering these four common manifestations of impaired SMC, motion at each of the five joint levels is scored on a four-point scale as: no SMC (0 point), moderately diminished SMC (1 point), mildly diminished SMC (2 point), and normal SMC (3 point). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better SMC.
Time Frame
15 minutes
Title
Jebsen Taylor Hand Function Test (JTHFT)
Description
The JTHFT consists of seven unimanual items that are administered using standardized procedures and verbal instructions and performed first with the nondominant hand and then with the dominant hand. The functional tasks on the JTHFT-IT include (a) writing a 24-letter, third-grade reading difficulty sentence; (b) turning 300-500 (7.62 cm by 12.7 cm) cards in simulated page turning; (c) picking up small common objects (including pennies, paper clips, and bottle caps) and placing them in a container; (d) stacking checkers; (e) simulated feeding; and (f) moving light cans and heavier (1 pound) cans. The subtests are scored by recording with a stopwatch the number of seconds required to complete each task.
Time Frame
10 minutes
Title
Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
Description
The PEDI-CAT is a comprehensive clinical assessment of functional skills acquired throughout infancy, childhood and adolescence up through the age of 20 years. Each of the four PEDI-CAT domains (daily activities, mobility, social/cognitive and responsibility) is independent and can be used separately or in combination with the other domains. Items in three of the domains focus on the child's ability to perform each functional activity in a manner that is effective given their abilities and challenges. The items in the responsibility domain examine the extent to which responsibility management for complex tasks has been shifted from parent to child. Items do not require the child to perform the activity in a standardized manner for scoring.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Emir, Msc
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34815
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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