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Video Based Games Exercise Training in Individuals With Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Physiotherapy
Video Game Based Exercise Training
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Spastic cerebral palsy, Virtual reality, Selective motor control, Fear of falling, Functional capacity

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Being diagnosed with spastic CP Being between the ages of 6-18 Being at level I, II, III according to MACS Being at level I, II, III according to GMFCS Scoring 24 points and above on the Mini Mental State Examination To have adequate communication skills The family agrees to the inclusion of their child in the study Child's willingness to participate in the study Regular attendance to exercise training within the specified time periods Exclusion Criteria: Any botulinum toxin application and surgical intervention to the lower and upper extremities in the last 6 months Serious vision and hearing problems Children who have difficulty understanding and following the rules of the game, Receiving surgery or botox application to the lower or upper extremity Individuals with joint contracture Those with pacemakers because they emit radio waves

Sites / Locations

  • Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physiotherapy Group

Video Game Based Exercise Training Group

Arm Description

30 minutes of upper and lower extremity strengthening exercises, upper and lower extremity stretching exercises, functional exercises to increase joint range of motion, tone regulation exercises, 30 minutes of weight transfer exercises to the upper and lower extremities, exercises to improve elective motor control (including isolated joint movements). exercises), balance and coordination exercises (weight transfer to the right-left, front-back on the balance board, cross-arm-leg exercises, exercises for balance and protective reactions), walking training will be applied.

30 minutes of upper and lower extremity strengthening exercises, upper and lower extremity stretching exercises, functional exercises to increase joint range of motion, tone regulation exercises, 30 minutes of XBox Video Games (10 minutes of Reflex Ridge, 10 minutes of Rallyball, 10 minutes of River rush games) will be applied.

Outcomes

Primary Outcome Measures

Selective Voluntary Motor Control of the Upper Extremities (SCUES)
SCUES is a test that evaluates selective motor control of the upper extremity with a score between 0-3. SCUES assesses the shoulder, elbow, forearm, wrist and fingers bilaterally
Selective Control Assessment of the Lower Extremity (SCALE)
It is a test that evaluates the selective motor control of the lower extremity with a score between 0 and 2. It evaluates the hip, knee, ankle and toe joints bilaterally.
Six Minute Walk Test (6MWT)
The 6MWT is a simple, submaximal, clinical exercise test that measures the distance walked in 6 minutes under controlled conditions. The 6MWT has been used in children with cerebral palsy (CP) in recent years. In these populations, the 6MWT is considered a measure of overall 'functional status' as 6MWT performance involves the integrated response of multiple body systems
Pediatric Fear of Falling Questionnaire
It is a scale that assesses the fear of falling in activities of daily living in the pediatric population. There are 6 main topics. There are a total of 34 items in which children's fear of falling is questioned during different activities. Participants receive a score between 0 and 68, with higher scores indicating higher fear of falling.

Secondary Outcome Measures

Pediatric Balance Scale (PBS)
Assesses children's balance and consist of 14 items. Each item is scored between 0 and 4 points. Low score refers to the poor balance and the high score refers to the good balance.
Gross Motor Classification System (GMFCS)
This is a classification system for children with chronic disability and based on the movements initiated by the child him/herself such as sitting, moving and acting. GMFCS classifies gross motor functions of children with CP in five levels.
Manual Ability Classification System (MACS)
MACS is a five-level classification system that analyzes the children with CP use their hands while carrying objects in their daily activities.
Mini Mental State Examination
It consists of 13 items covering five cognitive skills (orientation, attention and working memory, episodic memory, language and structural praxis) that assess cognitive status. The maximum score that can be obtained from the test is 37.

Full Information

First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT06073743
Brief Title
Video Based Games Exercise Training in Individuals With Cerebral Palsy
Official Title
The Effect of Video Based Games Exercise Training on Selective Motor Control, Fear of Falling and Functional Capacity in Individuals With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

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

5. Study Description

Brief Summary
Cerebral palsy (CP) is a non-progressive neurological disorder characterized by a persistent decline in sensory, cognitive or especially gross and fine motor functions during infancy or early childhood. In children with spastic CP, spasticity, muscle weakness, delay in motor development, inadequacy of gross and fine motor skills, selective motor control and functional capacity may be affected. Selective motor control (SMC) is the ability to isolate a muscle or muscle group to perform a specific movement. In children with CP, spasticity directly causes impairment of SMC, as movement patterns governed by flexor or extensor synergies are affected, which inhibits functional movements. Motor dysfunction in CP causes activity limitations and can negatively affect functional capacity. In addition, falls may increase in individuals with CP due to poor balance control, resulting in pain, injury and disability, and may cause individuals to lose confidence in their ability to perform routine activities. Increased fear of falling in individuals with CP may also lead to restriction of activities.It was discussed that the interactive computer game has possible evidence of efficacy allowing to improve gross motor function in individuals with CP. It also appears to have the potential to produce gross motor improvements in terms of strength, balance, coordination and gait for individuals with CP.As a result of our literature review, studies investigating the effect of virtual reality games on gait, balance and coordination in children with CP were observed. However, the effect of virtual reality games on selective motor control has not been sufficiently investigated. The aim of our study, which is planned to eliminate this deficiency in the literature, is to investigate the effect of video game-based exercise training, which provides higher motivation than conventional physical therapy methods, on selective motor control, fear of falling and functional capacity in individuals with CP.
Detailed Description
The effect of Virtual Reality Kinect video games, which provide higher motivation than conventional physical therapy methods, on selective motor control, fear of falling and functional capacity will be examined. The study will include children with spastic CP between the ages of 6-18 years who are attending a Special Education and Rehabilitation Center and who agree to participate in the study. According to the power analysis based on the reference article, it is planned to include 26 people in the study, 13 in the convention physiotherapy group and 13 in the video game-based exercise group. The families of the children included in the study will be asked to sign an Informed Consent Form and the children will be asked to sign a Child Consent Form for Research Purposes. Demographic data such as gender, age, type of extremity involvement, age at diagnosis will be recorded before the training. The cognitive level of the individuals will be evaluated with the Mini Mental State test, gross motor levels will be classified according to the Gross Motor Function Classification System and hand skills will be classified according to the Hand Skills Classification System. Selective motor control of the upper extremity will be evaluated with the Selective Control of Upper Extremity Evaluation Scale (SCUES) and selective motor control of the lower extremity will be evaluated with the Selective Control of Lower Extremity Evaluation Scale (SCALE). Individuals' balance skills in daily living activities will be evaluated with the Pediatric Balance Scale, fear of falling will be evaluated with the Pediatric Fear of Falling Scale, and functional capacity will be evaluated with the 6-minute walk test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Spastic cerebral palsy, Virtual reality, Selective motor control, Fear of falling, Functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physiotherapy Group
Arm Type
Active Comparator
Arm Description
30 minutes of upper and lower extremity strengthening exercises, upper and lower extremity stretching exercises, functional exercises to increase joint range of motion, tone regulation exercises, 30 minutes of weight transfer exercises to the upper and lower extremities, exercises to improve elective motor control (including isolated joint movements). exercises), balance and coordination exercises (weight transfer to the right-left, front-back on the balance board, cross-arm-leg exercises, exercises for balance and protective reactions), walking training will be applied.
Arm Title
Video Game Based Exercise Training Group
Arm Type
Experimental
Arm Description
30 minutes of upper and lower extremity strengthening exercises, upper and lower extremity stretching exercises, functional exercises to increase joint range of motion, tone regulation exercises, 30 minutes of XBox Video Games (10 minutes of Reflex Ridge, 10 minutes of Rallyball, 10 minutes of River rush games) will be applied.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
The conventional physiotherapy program will be applied 2 days a week, 60 minutes a day for 10 weeks and consist of weight bearing on the upper and lower extremities, strengthening, functional stretching exercises, walking training and balance exercises.
Intervention Type
Other
Intervention Name(s)
Video Game Based Exercise Training
Intervention Description
In the Video Game Based Exercise Training program, in addition to the same conventional physiotherapy application for 30 minutes a day, 2 days a week for 10 weeks, 30 minutes of Microsoft Xbox Kinect video games such as reflex ridge and rallyball are used.
Primary Outcome Measure Information:
Title
Selective Voluntary Motor Control of the Upper Extremities (SCUES)
Description
SCUES is a test that evaluates selective motor control of the upper extremity with a score between 0-3. SCUES assesses the shoulder, elbow, forearm, wrist and fingers bilaterally
Time Frame
10 weeks
Title
Selective Control Assessment of the Lower Extremity (SCALE)
Description
It is a test that evaluates the selective motor control of the lower extremity with a score between 0 and 2. It evaluates the hip, knee, ankle and toe joints bilaterally.
Time Frame
10 weeks
Title
Six Minute Walk Test (6MWT)
Description
The 6MWT is a simple, submaximal, clinical exercise test that measures the distance walked in 6 minutes under controlled conditions. The 6MWT has been used in children with cerebral palsy (CP) in recent years. In these populations, the 6MWT is considered a measure of overall 'functional status' as 6MWT performance involves the integrated response of multiple body systems
Time Frame
10 weeks
Title
Pediatric Fear of Falling Questionnaire
Description
It is a scale that assesses the fear of falling in activities of daily living in the pediatric population. There are 6 main topics. There are a total of 34 items in which children's fear of falling is questioned during different activities. Participants receive a score between 0 and 68, with higher scores indicating higher fear of falling.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Pediatric Balance Scale (PBS)
Description
Assesses children's balance and consist of 14 items. Each item is scored between 0 and 4 points. Low score refers to the poor balance and the high score refers to the good balance.
Time Frame
10 weeks
Title
Gross Motor Classification System (GMFCS)
Description
This is a classification system for children with chronic disability and based on the movements initiated by the child him/herself such as sitting, moving and acting. GMFCS classifies gross motor functions of children with CP in five levels.
Time Frame
Baseline
Title
Manual Ability Classification System (MACS)
Description
MACS is a five-level classification system that analyzes the children with CP use their hands while carrying objects in their daily activities.
Time Frame
Baseline
Title
Mini Mental State Examination
Description
It consists of 13 items covering five cognitive skills (orientation, attention and working memory, episodic memory, language and structural praxis) that assess cognitive status. The maximum score that can be obtained from the test is 37.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Being diagnosed with spastic CP Being between the ages of 6-18 Being at level I, II, III according to MACS Being at level I, II, III according to GMFCS Scoring 24 points and above on the Mini Mental State Examination To have adequate communication skills The family agrees to the inclusion of their child in the study Child's willingness to participate in the study Regular attendance to exercise training within the specified time periods Exclusion Criteria: Any botulinum toxin application and surgical intervention to the lower and upper extremities in the last 6 months Serious vision and hearing problems Children who have difficulty understanding and following the rules of the game, Receiving surgery or botox application to the lower or upper extremity Individuals with joint contracture Those with pacemakers because they emit radio waves
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuriye Özengin
Phone
05554789852
Email
ozengin_n@ibu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sezen Tezcan
Organizational Affiliation
Bolu Abant Izzet Baysal University, Faculty of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Süveybe Yavaş
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Video Based Games Exercise Training in Individuals With Cerebral Palsy

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