- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06073743
Video Based Games Exercise Training in Individuals With Cerebral Palsy
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bolu, Turkey, 14280
- Abant Izzet Baysal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Physiotherapy Group
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.
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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.
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Experimental: Video Game Based Exercise Training Group
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric Fear of Falling Questionnaire
Time Frame: 10 weeks
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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.
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10 weeks
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Selective Voluntary Motor Control of the Upper Extremities (SCUES)
Time Frame: 10 weeks
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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.
Motion at each of the five joint levels is graded on a four-point scale: Normal Selective Motor Control (3 points) M3, Mildly Diminished Selective Motor Control (2 points) M2, Moderately, Diminished Selective Motor Control (1 point) M1, No Selective Motor Control (0 points) M0.
Higher scores mean a better outcomes.
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10 weeks
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Selective Control Assessment of the Lower Extremity (SCALE)
Time Frame: 10 weeks
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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.Scoring is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).Higher scores mean a better outcomes.
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10 weeks
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Six Minute Walk Test (6MWT)
Time Frame: 10 weeks
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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.
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10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric Balance Scale (PBS)
Time Frame: 10 weeks
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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.
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10 weeks
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Gross Motor Classification System (GMFCS)
Time Frame: Baseline
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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.
As the level increases, the level of motor function decreases.
Individuals at level 1 have better motor function.
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Baseline
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Manual Ability Classification System (MACS)
Time Frame: Baseline
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MACS is a five-level classification system that analyzes the children with CP use their hands while carrying objects in their daily activities.Hand function deteriorates as the level increases.
Individuals at level 1 have the best manual ability, while individuals at level 5 have the worst manual ability.
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Baseline
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Modified Mini Mental Test (MMMT)
Time Frame: Baseline
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The MMMT adapted for children is used to examine cognitive functions in children from the age of 4 years.
The test, which takes 5 to 10 minutes to administer, assesses 5 cognitive areas, including orientation, memory, concentration, language functions and measures of structural ability.
The total score on the test reaches a plateau at around 9-10 years of age.
In children over 10 years of age, scores below 27 out of a total of 35 points are indicative of mental retardation.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sezen Tezcan, Bolu Abant İzzet Baysal University, Faculty of Health Sciences
- Principal Investigator: Süveybe Yavaş, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-ST-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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