Spastic Cerebral PalsyNCT06073743
Video Based Games Exercise Training in Individuals With Cerebral Palsy
A study testing Conventional Physiotherapy and Video Game Based Exercise Training in people with Spastic Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Conventional Physiotherapy and Video Game Based Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2023to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Conventional Physiotherapy, Video Game Based Exercise Training
- Keywords
- Spastic cerebral palsy, Virtual reality, Selective motor control, Fear of falling, Functional capacity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
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.
Video Game Based Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | 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. Receives: Other: Conventional Physiotherapy |
| Video Game Based Exercise Training Group | Experimental | 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. Receives: Other: Conventional Physiotherapy; Other: Video Game Based Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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.
Measured: 10 weeks
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.Scoring is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).Higher scores mean a better outcomes.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Secondary outcomes (4)
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.
Measured: 10 weeks
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. As the level increases, the level of motor function decreases. Individuals at level 1 have better motor function.
Measured: Baseline
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.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.
Measured: Baseline
Modified Mini Mental Test (MMMT)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Dec 2023
- Primary completion7 Jan 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sezen Tezcan, Principal investigator, Bolu Abant Izzet Baysal University, Faculty of Health SciencesSüveybe Yavaş, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073743
- Sponsor's protocol ID
- AIBU-FTR-ST-03
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06073743
- Acronym / sponsor ID
- AIBU-FTR-ST-03
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Spastic cerebral palsy, Virtual reality, Selective motor control, Fear of falling, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | Other: Conventional Physiotherapy30 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. |
| Video Game Based Exercise Training Group | Experimental | Other: Conventional Physiotherapy, Other: Video Game Based Exercise Training30 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyThe 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. | Other | Conventional Physiotherapy Group, Video Game Based Exercise Training Group |
| Video Game Based Exercise TrainingIn 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. | Other | Video Game Based Exercise Training Group |
Primary outcome
Selective Voluntary Motor Control of the Upper Extremities (SCUES)
Time frame: 10 weeks
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.
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: 10 weeks
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.
Six Minute Walk Test (6MWT)
Time frame: 10 weeks
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
Time frame: 10 weeks
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.
4 secondary outcomes
Pediatric Balance Scale (PBS)
Time frame: 10 weeks
Gross Motor Classification System (GMFCS)
Time frame: Baseline
Manual Ability Classification System (MACS)
Time frame: Baseline
Modified Mini Mental Test (MMMT)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sezen Tezcan principal investigator
Bolu Abant Izzet Baysal University, Faculty of Health Sciences
Süveybe Yavaş principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Video Game Based Exercise Training in people with Spastic Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Voluntary Motor Control of the Upper Extremities (SCUES) (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.