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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802655
• Other study ID #: E-10840098-772.02-65173
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: July 15, 2023

Study information

• Verified date: October 2023
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Ahmet Emir

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Primary	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.	10 minutes
Primary	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.	15 minutes
Secondary	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.	15 minutes
Secondary	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.	10 minutes
Secondary	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.	15 minutes