Physical DisabilityNCT04954144
Role of Virtual Reality in Hand Rehabilitation for Children With Cerebral Palsy
A study testing Leap Motion Sensor and Neurodevelopmental Treatment Approach in people with Physical Disability and Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a neurodevelopmental dysfunction which is permanent, non-progressive, and caused by brain insult or injury.Although the basic finding of CP is having motor function problems, visual, auditory, cognitive and behavioural problems are also seen in CP.Having these problems interfere the functional… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Physical Disability, Cerebral Palsy
- What is being tested?
- Leap Motion Sensor and Neurodevelopmental Treatment Approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2021to 20 Apr 2021
- 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
- Gross Motor Functional Level should be I or II.
Who cannot join
- Epilepsy
- Visual Impairment
- Cognitive Problem
- Inability to hold and release the objects
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Silivri Rehabilitation Center
Istanbul, Silivri, 34520
About this study
Official title: The Effect of Fine Motor Grip Studies in Virtual Reality Environment on Performance-Based Hand Skills in Children With Cerebral Palsy
Cerebral Palsy (CP) is a neurodevelopmental dysfunction which is permanent, non-progressive, and caused by brain insult or injury.Although the basic finding of CP is having motor function problems, visual, auditory, cognitive and behavioural problems are also seen in CP.Having these problems interfere the functional independence of children with CP, so their daily life of activities is limited.One of the way of increasing the functional independence of these children is providing them hand rehabilitation.In the event of having hand rehabilitation, children would achieve more daily living skills.Although having hand rehabilitation is crucial for these children, they would lose their motivation on this by the time because rehabilitation is a long process,For that reason, new therapy techniques are tried by therapists to motivate these children during their rehabilitation seances.Virtual reality rehabilitation is one of these new techniques used for designing enjoyable and effective seances.Especially leap motion sensors are preferred to create virtual environment, because they are cheap, portable, touchless and easy to use.These sensors can detect hand movements and recognize hand gestures by using infrared.Our study was aimed to investigate the effect of fine motor grip studies in virtual reality environment on performance based hand skills in children with CP.Thirty two children with CP (6-18) were included in this study.Children were randomly assigned into two equal-sized groups: control and study groups.Participants in both groups received a neurodevelopmental therapy program.The study group additionally received virtual reality rehabilitation programme. In control group, neurodevelopmental treatment was provided 45 mins,2 d/week for 2 successive months.In study group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme was provided 15 mins, 2 d/week for 2 successive months. To evaluate the performance based hand skills; Box and Block Test, Nine Hole Peg Test and Pink Tower (Montessori) Test were used.
Read the detailed description
Cerebral palsy (CP) can be defined as a permanent, non-progressive, motor function, posture and developmental disorder that causes movement limitation due to a lesion that can occur in the brain due to prenatal, perinatal and postnatal reasons.Although the etiology of the disease cannot be determined precisely, the reasons causing SP; It is stated that it occurs in prenatal, perinatal and postnatal periods. Sometimes, more than one factor can be found together.Another common problem in individuals with CP is seen in upper extremity functions, and limiting upper extremity functions also affects the independence of daily living activities. The condition of the hand in the early period of rehabilitation has an important place for upper extremity functions in the future.In this respect, it is very important to include a program to develop manual skills in the rehabilitation process in order to make children with CP more independent in daily life activities.Neurodevelopmental Treatment Approach, widely used in the treatment of children with Cerebral Palsy; It is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques.Virtual reality is a three-dimensional simulation that makes you feel to be in any "place" and provides this by giving various inputs to our sensory organs. According to motor control and motor learning theory, it is important to carry out repetitive, target-oriented studies that increase motivation in the rehabilitation of children with Cerebral Palsy and it is important to include games and entertainment in the treatment program. To achieve this, making virtual reality a component of rehabilitation can cause the treatment process to be more functional and effective.Research has shown that computer games designed for a specific purpose can increase the motivation of children to increase the use of the affected extremities and positively improve the strength and functionality of the affected muscles.Leap Motion Sensors have been developed to detect hand movements. It can detect the movement of the hand by emitting infrared rays in a restricted area. Physiotherapists have stated that virtual reality rehabilitation applied with Leap Motion Sensors can be an effective method that increases motivation in the treatment process in children with special needs.Our study was aimed to investigate the effect of fine motor grip studies in virtual reality environment on performance based hand skills in children with CP.After the approval of the ethics committee, children with cerebral palsy were included in the study.Parental approval was obtained.Reports from Health Council was examined to check diagnosis of children.The study was performed in three centers: University of Abant Izzet Baysal, Silivri Rehabilitation Center and Reyhan Rehabilitation Center.Thirty two children with CP (6-18) were included in this study.Exclusion criteria were; epilepsy history, cognitive problems, visual impairment, having problem on holding and releasing the objects.Children were randomly assigned into two equal-sized groups: control and study groups.Participants in both groups received a neurodevelopmental therapy program.The study group additionally received virtual reality rehabilitation programme.As a normal developmental treatment method, functional skills exercises, inhibition of abnormal movement patterns, sensory-motor integration in purposeful movements, stretching and strengthening exercises, and daily life activities were trained.As a virtual reality treatment method, object catching, firefly, bee-batting games were used, which improved performance-dependent dexterity by integrating leap motion sensors into the laptop.In control group, neurodevelopmental treatment was provided 45 mins,2 days/week for 2 successive months.In study group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme was provided 15 mins, 2 days/week for 2 successive months.In virtual reality treatment, each game was studied for 5 minutes and 3 games for a total of 15 minutes.Before and after the study, tests that measure performance-related dexterity were applied and the previous and next results of the groups were compared.SPSS statistics program was used for statistical evaluation of data belonging to participants.In statistical evaluations, p <0.05 was considered as significant.In the data analysis of the study, in order to select the appropriate statistical analysis, whether the distribution of the data is suitable for normal distribution was determined by the "one-sample Kolmogorov-Smirnov" test."Independent T Test" was used to compare age, height, body weight, the measures pre-treatment and post-treatment, .Gender and affected sides were compared by using "Chi-Square Test".
- Conditions
- Physical Disability, Cerebral Palsy
- Being tested
- Leap Motion Sensor, Neurodevelopmental Treatment Approach
- Keywords
- cerebral palsy, virtual rehabilitation, hand rehabilitation, leap motion
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leap Motion SensorDevice
As a virtual reality treatment method, leap motion sensor was integrated with laptop computer and participants played object capture, firefly, bee-batting games to improve performance based hand skills.
Neurodevelopmental Treatment ApproachOther
It is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques.
| Study group | Role | What they receive |
|---|---|---|
| Leap Motion Sensor | Experimental | The Leap Motion Sensor is an optical hand tracking module that captures the movements of hands with unparalleled accuracy. Receives: Device: Leap Motion Sensor; Other: Neurodevelopmental Treatment Approach |
| Neurodevelopmental Treatment Approach | Experimental | Neurodevelopment treatment approach is used to influence the quality of the motor response and is carefully matched to the patient's abilities to use sensory information and adapt movements. Receives: Other: Neurodevelopmental Treatment Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABILHANDS-kids Scoring Before Study
Measure of manual ability for children with upper limb impairments before study.
Measured: Day 1
ABILHANDS-kids Scoring After Study
Measure of manual ability for children with upper limb impairments after study.
Measured: Day 56
Manual Ability Classification System
It describes how children with cerebral palsy use their hands to handle objects in daily activities.
Measured: Day 1
Gross Motor Function Classification
It description of a child's current motor function
Measured: Day 1
Box and Block Test Before Study
It measures unilateral gross manual dexterity before study.
Measured: Day 1
Box and Block Test After Study
It measures unilateral gross manual dexterity after study.
Measured: Day 56
9 Hole Peg Test Before Study
It is a standardized, quantitative assessment used to measure finger dexterity before study.
Measured: Day 1
9 Hole Peg Test After Study
It is a standardized, quantitative assessment used to measure finger dexterity after study.
Measured: Day 56
Pink Tower Montessori Test Before Study
It measures performance based hand skill before study.
Measured: Day 1
Pink Tower Montessori Test After Study
It measures performance based hand skill after study.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start16 Feb 2021
- Primary completion13 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Neriman NARİN, Abant Izzet Baysal University
- Investigators
- Ayşe Neriman Narin, Asst.Prof, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954144
- Sponsor's protocol ID
- AIBU-FTR-ANN-01
- Status last verified
- Jul 2021
- First submitted
- 26 Apr 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fine Motor Grip Studies in Virtual Reality Environment on Performance-Based Hand Skills in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04954144
- Acronym / sponsor ID
- AIBU-FTR-ANN-01
- Conditions
- Physical Disability, Cerebral Palsy
- Keywords
- cerebral palsy, virtual rehabilitation, hand rehabilitation, leap motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 8 Jul 2021 (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 neurodevelopmental dysfunction which is permanent, non-progressive, and caused by brain insult or injury.Although the basic finding of CP is having motor function problems, visual, auditory, cognitive and behavioural problems are also seen in CP.Having these problems interfere the functional independence of children with CP, so their daily life of activities is limited.One of the way of increasing the functional independence of these children is providing them hand rehabilitation.In the event of having hand rehabilitation, children would achieve more daily living skills.Although having hand rehabilitation is crucial for these children, they would lose their motivation on this by the time because rehabilitation is a long process,For that reason, new therapy techniques are tried by therapists to motivate these children during their rehabilitation seances.Virtual reality rehabilitation is one of these new techniques used for designing enjoyable and effective seances.Especially leap motion sensors are preferred to create virtual environment, because they are cheap, portable, touchless and easy to use.These sensors can detect hand movements and recognize hand gestures by using infrared.Our study was aimed to investigate the effect of fine motor grip studies in virtual reality environment on performance based hand skills in children with CP.Thirty two children with CP (6-18) were included in this study.Children were randomly assigned into two equal-sized groups: control and study groups.Participants in both groups received a neurodevelopmental therapy program.The study group additionally received virtual reality rehabilitation programme. In control group, neurodevelopmental treatment was provided 45 mins,2 d/week for 2 successive months.In study group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme was provided 15 mins, 2 d/week for 2 successive months. To evaluate the performance based hand skills; Box and Block Test, Nine Hole Peg Test and Pink Tower (Montessori) Test were used.
Detailed description
Cerebral palsy (CP) can be defined as a permanent, non-progressive, motor function, posture and developmental disorder that causes movement limitation due to a lesion that can occur in the brain due to prenatal, perinatal and postnatal reasons.Although the etiology of the disease cannot be determined precisely, the reasons causing SP; It is stated that it occurs in prenatal, perinatal and postnatal periods. Sometimes, more than one factor can be found together.Another common problem in individuals with CP is seen in upper extremity functions, and limiting upper extremity functions also affects the independence of daily living activities. The condition of the hand in the early period of rehabilitation has an important place for upper extremity functions in the future.In this respect, it is very important to include a program to develop manual skills in the rehabilitation process in order to make children with CP more independent in daily life activities.Neurodevelopmental Treatment Approach, widely used in the treatment of children with Cerebral Palsy; It is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques.Virtual reality is a three-dimensional simulation that makes you feel to be in any "place" and provides this by giving various inputs to our sensory organs. According to motor control and motor learning theory, it is important to carry out repetitive, target-oriented studies that increase motivation in the rehabilitation of children with Cerebral Palsy and it is important to include games and entertainment in the treatment program. To achieve this, making virtual reality a component of rehabilitation can cause the treatment process to be more functional and effective.Research has shown that computer games designed for a specific purpose can increase the motivation of children to increase the use of the affected extremities and positively improve the strength and functionality of the affected muscles.Leap Motion Sensors have been developed to detect hand movements. It can detect the movement of the hand by emitting infrared rays in a restricted area. Physiotherapists have stated that virtual reality rehabilitation applied with Leap Motion Sensors can be an effective method that increases motivation in the treatment process in children with special needs.Our study was aimed to investigate the effect of fine motor grip studies in virtual reality environment on performance based hand skills in children with CP.After the approval of the ethics committee, children with cerebral palsy were included in the study.Parental approval was obtained.Reports from Health Council was examined to check diagnosis of children.The study was performed in three centers: University of Abant Izzet Baysal, Silivri Rehabilitation Center and Reyhan Rehabilitation Center.Thirty two children with CP (6-18) were included in this study.Exclusion criteria were; epilepsy history, cognitive problems, visual impairment, having problem on holding and releasing the objects.Children were randomly assigned into two equal-sized groups: control and study groups.Participants in both groups received a neurodevelopmental therapy program.The study group additionally received virtual reality rehabilitation programme.As a normal developmental treatment method, functional skills exercises, inhibition of abnormal movement patterns, sensory-motor integration in purposeful movements, stretching and strengthening exercises, and daily life activities were trained.As a virtual reality treatment method, object catching, firefly, bee-batting games were used, which improved performance-dependent dexterity by integrating leap motion sensors into the laptop.In control group, neurodevelopmental treatment was provided 45 mins,2 days/week for 2 successive months.In study group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme was provided 15 mins, 2 days/week for 2 successive months.In virtual reality treatment, each game was studied for 5 minutes and 3 games for a total of 15 minutes.Before and after the study, tests that measure performance-related dexterity were applied and the previous and next results of the groups were compared.SPSS statistics program was used for statistical evaluation of data belonging to participants.In statistical evaluations, p <0.05 was considered as significant.In the data analysis of the study, in order to select the appropriate statistical analysis, whether the distribution of the data is suitable for normal distribution was determined by the "one-sample Kolmogorov-Smirnov" test."Independent T Test" was used to compare age, height, body weight, the measures pre-treatment and post-treatment, .Gender and affected sides were compared by using "Chi-Square Test".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leap Motion Sensor | Experimental | Device: Leap Motion Sensor, Other: Neurodevelopmental Treatment ApproachThe Leap Motion Sensor is an optical hand tracking module that captures the movements of hands with unparalleled accuracy. |
| Neurodevelopmental Treatment Approach | Experimental | Other: Neurodevelopmental Treatment ApproachNeurodevelopment treatment approach is used to influence the quality of the motor response and is carefully matched to the patient's abilities to use sensory information and adapt movements. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Gross Motor Functional Level should be I or II.
Key exclusion criteria (4 listed)
- Epilepsy
- Visual Impairment
- Cognitive Problem
- Inability to hold and release the objects
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 |
|---|---|---|
| Leap Motion SensorAs a virtual reality treatment method, leap motion sensor was integrated with laptop computer and participants played object capture, firefly, bee-batting games to improve performance based hand skills. | Device | Leap Motion Sensor |
| Neurodevelopmental Treatment ApproachIt is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques. | Other | Leap Motion Sensor, Neurodevelopmental Treatment Approach |
Primary outcome
ABILHANDS-kids Scoring Before Study
Time frame: Day 1
Measure of manual ability for children with upper limb impairments before study.
ABILHANDS-kids Scoring After Study
Time frame: Day 56
Measure of manual ability for children with upper limb impairments after study.
Manual Ability Classification System
Time frame: Day 1
It describes how children with cerebral palsy use their hands to handle objects in daily activities.
Gross Motor Function Classification
Time frame: Day 1
It description of a child's current motor function
Box and Block Test Before Study
Time frame: Day 1
It measures unilateral gross manual dexterity before study.
Box and Block Test After Study
Time frame: Day 56
It measures unilateral gross manual dexterity after study.
9 Hole Peg Test Before Study
Time frame: Day 1
It is a standardized, quantitative assessment used to measure finger dexterity before study.
9 Hole Peg Test After Study
Time frame: Day 56
It is a standardized, quantitative assessment used to measure finger dexterity after study.
Pink Tower Montessori Test Before Study
Time frame: Day 1
It measures performance based hand skill before study.
Pink Tower Montessori Test After Study
Time frame: Day 56
It measures performance based hand skill after study.
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 8 Jul 2021.
- 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.
Ayşe Neriman Narin, Asst.Prof 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 Leap Motion Sensor and Neurodevelopmental Treatment Approach in people with Physical Disability and 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 1 inclusion and 4 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 8 Jul 2021. 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?
ABILHANDS-kids Scoring Before Study (time frame: Day 1). The study lists 10 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 8 Jul 2021.