Cerebral PalsyNCT04529343
Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy
A study testing Virtual reality mediated upper extremity rehabilitation and Classical exercise therapy for upper extremities in people with Cerebral Palsy and Upper Extremity Paresis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) refers to a group of permanent disorders that occur in the brain of the fetus or infant, which are non-progressive, cause movement and posture disorder along with activity limitation. The upper extremity is frequently affected in patients with CP. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity Paresis
- What is being tested?
- Virtual reality mediated upper extremity rehabilitation and Classical exercise therapy for upper extremities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2020to 30 Dec 2020
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having been diagnosed with hemiplegic CP by a specialist pediatric neurologist,
- Being between the ages of 5-12,
- Following the child's simple commands and participating in the given tasks,
- Being at the Gross Motor Function Classification System (KMFSS) Stage 1, 2 or 3,
- Being in Hand Skills Classification System (MACS) Stage 1, 2 or 3,
- Mild / moderate muscle tone; Modified Ashworth Scale level 1-2 and Tardieu Scale level 1-2,
- Parents agree to participate in the intensive treatment program and to cease all other upper extremity therapeutic interventions during the 3-month follow-up period.
Who cannot join
- Having uncontrollable epileptic seizures
- Significant contractures in the fingers, wrists, elbows and shoulders that prevent daily activities,
- Having serious vision and hearing problems,
- Cognitive impairments that prevent understanding and performing simple commands and tasks,
- Not being able to continue the treatment protocol due to the school program,
- Current or previous treatments that are not compatible with the treatment protocol of the study,
Show all 9Show fewer
- Orthopedic surgery (tendon transfer / tendon lengthening) applied to the upper extremity,
- Receiving upper extremity treatment within the last 6 months (BTX-A or orthopedic interventions),
- Uncontrolled disease (endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal), active systemic inflammatory disease and / or history of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Virtual Reality-Based Upper Extremity Rehabilitation in Patients With Cerebral Palsy
Cerebral palsy (CP) refers to a group of permanent disorders that occur in the brain of the fetus or infant, which are non-progressive, cause movement and posture disorder along with activity limitation.
The upper extremity is frequently affected in patients with CP. The prevalence of upper extremity involvement has been reported between 60-83% in different studies.
Virtual reality applications have been increasing recently in the field of neurological rehabilitation. In this study, researchers aimed to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation in patients with hemiplegic cerebral palsy.
Read the detailed description
Cerebral Palsy (CP) is a group of permanent disorders of movement and posture development due to non-progressive damage to the developing fetal or infant brain, causing activity limitation. Motor disorders in CP are mostly accompanied by sensory and perceptual problems, cognitive disorders, communicative and perceptual problems, epilepsy and secondary musculoskeletal problems. CP is one of the most common causes of disability in childhood. Brain damage that causes CP can occur in the prenatal, perinatal or postnatal period. Accompanying epilepsy, cognitive disorders, learning impairment, communication problems, perception limitation, behavioral problems, visual disturbances, hearing disorders, oral motor function problems, dysphagia, constipation, gastroesophageal reflux disease, dental problems, urinary symptoms, osteoporosis can be seen in patients with CP.
Technologies that are developing in rehabilitation are increasingly being used. Among these technologies, the use of virtual reality by trained physiatrists and physiotherapists provides an environment where children with cerebral palsy can exercise. In addition to intense exercise, simultaneous visual and auditory feedback can be received. Virtual reality can also provide a comparison between the degree of movement children perform in the real world and the degree of movements they observe in the virtual environment. All these features make virtual reality a potentially viable tool for improving the motor skills of children with CP.
Virtual reality-based rehabilitation is an emerging treatment modality for the motor rehabilitation of children with cerebral palsy. Neuroplasticity studies have shown that neurological development is positively associated with active participation and motivation during virtual reality-based rehabilitation intervention. In addition to motivation, virtual therapy also improves neural reorganization that optimizes rehabilitation outcomes in children with cerebral palsy. The virtual scenario seems to encourage motor learning, the retention of learned skills, and the transfer of skills to real-world situations. In many studies, improvement in posture, balance, upper extremity functions, joint control and walking has been detected with virtual therapy. Increased 'biofeedbacks' in neuromotor rehabilitation allowed therapists to methodologically design and control their intervention strategies.
40 patients with a diagnosis of Cerebral Palsy who applied to the Pediatric Rehabilitation Unit of Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, who meet the inclusion criteria will be included in this randomized, controlled, single blind and prospectively planned study. At the beginning of the study, 40 hemiplegic CP patients who meet the inclusion criteria will be randomized into two groups according to the random order created by the computer program after being numbered according to the order of application to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Pediatric Rehabilitation Unit. Upper extremity rehabilitation (bimanually 3 days a week for 6 weeks and 45 minutes per session) and physiotherapy (TG: Treatment Group) will be given to the first group accompanied by virtual reality, and only physiotherapy (CG: Control Group) will be given to the second group.
When the power analysis was performed to calculate the number of patients and when the results obtained from other studies were taken into account, it was concluded that at least 18 patients should be included in each group to obtain 0.95 power at 95% confidence interval. Considering that few people will be excluded from the study during the study, it was found appropriate to include 20 patients in each group and to start the study with a total of 40 people. Before starting the study, the patients will be informed about the study and their consent will be obtained and demographic characteristics such as age, height and weight will be evaluated.
Participants and their parents will be informed in writing and verbally about the purpose, duration and method of application of the research, and the "Informed Consent Form" will be signed after their consent is obtained.
The study is planned to be carried out in a single center in the Department of Physical Medicine and Rehabilitation of Istanbul University Istanbul Medical Faculty.
The virtual reality technology to be used in the study has temporary side effects such as nausea, vomiting, and dizziness, and side effects to increase epileptic seizures. For this reason, patients with uncontrolled epileptic seizures were excluded from the study. If effects such as nausea, vomiting and dizziness develop during the intervention, the session will be terminated and symptomatic treatment will be given.
- Conditions
- Cerebral Palsy, Upper Extremity Paresis
- Being tested
- Virtual reality mediated upper extremity rehabilitation, Classical exercise therapy for upper extremities
- Keywords
- virtual reality, rehabilitation, gamification
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality mediated upper extremity rehabilitationOther
Game-based exercise will be applied for different range of motion of the upper extremity. Gamified exercise program consisting of 4 different scenarios will be applied 3 days a week for 6 weeks to the patients in the virtual reality group. A session takes an average of 45 minutes.
Games to be applied;
- Finger flexion-extension (10 minutes / session)
- Wrist flexion, extension, ulnar and radial deviation (10 minutes / session)
- Forearm pronation and supination (10 minutes / session)
- Elbow flexion-extension-shoulder internal and external rotation (15 minutes / session) will have scenarios controlled with. All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes.
Classical exercise therapy for upper extremitiesOther
All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | To the virtual reality group; In addition to upper extremity exercises applied 2 days a week, upper extremity rehabilitation via virtual reality glasses will be performed 3 days a week for 6 weeks and each session will be 45 minutes. Receives: Other: Virtual reality mediated upper extremity rehabilitation; Other: Classical exercise therapy for upper extremities |
| Control Group | Active comparator | Upper extremity exercises will be applied to the participants in the control group 2 days a week for 6 weeks. Receives: Other: Classical exercise therapy for upper extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment (AHA)
AHA is a test that measures how patients with impaired upper extremity functions, such as hemiplegic CP or congenital brachial plexus injury, use the affected hand together with the healthy hand when playing with both hands. The AHA 5.0 version consists of 20 items that evaluate hand functions, and the raw score range is between 20 and 80 points. Higher scores indicate better hand function.
Measured: 12 weeks
Secondary outcomes (6)
Joint Range of Motion Measurement
Goniometric measurements of upper extremity range of motion will be done actively and passively.
Measured: 12 weeks
Modified Ashworth Scale
Evaluation of upper extremity spasticity will be done with a modified Ashworth scale.The modified ashworth scale is scored between 0 and 4, with higher scores indicating severe spasticity.
Measured: 12 weeks
Tardieu Scale
Evaluation of upper extremity spasticity will be done with a Tardieu scale. The Tardieu scale is scored between 0 and 5, with higher scores indicating severe spasticity.
Measured: 12 weeks
ABILHAND-Kids
ABILHAND-Kids is a functional scale that is used to measure hand ability in patients, guiding the treatment planning of CP and similar childhood neurological diseases, determining targets. ABILHAND-Kids evaluates the hand functions of patients with 21 items, and each item is scored between 0-2 points. Higher scores indicate better hand function. (Minimum: 0, Maximum: 42 points)
Measured: 12 weeks
QUEST
Upper extremity motion quality and hand skills of patients with CP were evaluated by QUEST.
This test consists of 5 parts. In the test, each item is scored between 0 and 2, depending on whether it can perform the action or not. It has subtitles including independent movements, grasping, weight bearing, protective extension, hand function degree, spasticity rating and cooperation rating. Higher scores indicate better upper limb function. (Minimum: 0, Maximum: 100 points)
Measured: 12 weeks
KINDL
KINDL is a questionnaire prepared in 1994 to evaluate the quality of life in the pediatric population and adolescents. There are various forms of the questionnaire for children of different age groups and families. The items in this test are scored between 1-5 points. Higher scores indicate better upper limb function. (Minimum: 0, Maximum: 100 points)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start20 Aug 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Model description
- The virtual reality group will be given upper extremity rehabilitation via virtual reality glasses (3 days a week for 6 weeks and 45 minutes each session) and upper extremity exercises 2 days a week, while the control group will only be given upper extremity exercises 2 days a week.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ahmet Kivanc Menekseoglu, Istanbul University
- Investigators
- Ayşe Resa Aydın, Prof. Dr., Principal investigator, Istanbul University Istanbul Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529343
- Sponsor's protocol ID
- 2018/1442
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data kept in the study will be shared with other researchers in case of a possible scientific publication. Personal data of the patients will not be shared, data of primary and secondary outcome criteria will be shared.
Publications
Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.
PubMed 28109566Cho C, Hwang W, Hwang S, Chung Y. Treadmill Training with Virtual Reality Improves Gait, Balance, and Muscle Strength in Children with Cerebral Palsy. Tohoku J Exp Med. 2016 Mar;238(3):213-8. doi: 10.1620/tjem.238.213.
PubMed 26947315Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
PubMed 29088476Ren Z, Wu J. The Effect of Virtual Reality Games on the Gross Motor Skills of Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 14;16(20):3885. doi: 10.3390/ijerph16203885.
PubMed 31614990Hung YC, Gordon AM. Virtual reality training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Apr;60(4):334-335. doi: 10.1111/dmcn.13699. Epub 2018 Feb 14. No abstract available.
PubMed 29442357Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Vision-based serious games and virtual reality systems for motor rehabilitation: A review geared toward a research methodology. Int J Med Inform. 2019 Nov;131:103909. doi: 10.1016/j.ijmedinf.2019.06.016. Epub 2019 Jul 10.
PubMed 31557701Menekseoglu AK, Capan N, Arman S, Aydin AR. Effect of a Virtual Reality-Mediated Gamified Rehabilitation Program on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy: A Prospective, Randomized Controlled Study. Am J Phys Med Rehabil. 2023 Mar 1;102(3):198-205. doi: 10.1097/PHM.0000000000002060. Epub 2022 Jun 9.
PubMed 35687751
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Virtual Reality-Based Upper Extremity Rehabilitation in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04529343
- Acronym / sponsor ID
- 2018/1442
- Conditions
- Cerebral Palsy, Upper Extremity Paresis
- Keywords
- virtual reality, rehabilitation, gamification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Aug 2020 (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) refers to a group of permanent disorders that occur in the brain of the fetus or infant, which are non-progressive, cause movement and posture disorder along with activity limitation.
The upper extremity is frequently affected in patients with CP. The prevalence of upper extremity involvement has been reported between 60-83% in different studies.
Virtual reality applications have been increasing recently in the field of neurological rehabilitation. In this study, researchers aimed to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation in patients with hemiplegic cerebral palsy.
Detailed description
Cerebral Palsy (CP) is a group of permanent disorders of movement and posture development due to non-progressive damage to the developing fetal or infant brain, causing activity limitation. Motor disorders in CP are mostly accompanied by sensory and perceptual problems, cognitive disorders, communicative and perceptual problems, epilepsy and secondary musculoskeletal problems. CP is one of the most common causes of disability in childhood. Brain damage that causes CP can occur in the prenatal, perinatal or postnatal period. Accompanying epilepsy, cognitive disorders, learning impairment, communication problems, perception limitation, behavioral problems, visual disturbances, hearing disorders, oral motor function problems, dysphagia, constipation, gastroesophageal reflux disease, dental problems, urinary symptoms, osteoporosis can be seen in patients with CP.
Technologies that are developing in rehabilitation are increasingly being used. Among these technologies, the use of virtual reality by trained physiatrists and physiotherapists provides an environment where children with cerebral palsy can exercise. In addition to intense exercise, simultaneous visual and auditory feedback can be received. Virtual reality can also provide a comparison between the degree of movement children perform in the real world and the degree of movements they observe in the virtual environment. All these features make virtual reality a potentially viable tool for improving the motor skills of children with CP.
Virtual reality-based rehabilitation is an emerging treatment modality for the motor rehabilitation of children with cerebral palsy. Neuroplasticity studies have shown that neurological development is positively associated with active participation and motivation during virtual reality-based rehabilitation intervention. In addition to motivation, virtual therapy also improves neural reorganization that optimizes rehabilitation outcomes in children with cerebral palsy. The virtual scenario seems to encourage motor learning, the retention of learned skills, and the transfer of skills to real-world situations. In many studies, improvement in posture, balance, upper extremity functions, joint control and walking has been detected with virtual therapy. Increased 'biofeedbacks' in neuromotor rehabilitation allowed therapists to methodologically design and control their intervention strategies.
40 patients with a diagnosis of Cerebral Palsy who applied to the Pediatric Rehabilitation Unit of Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, who meet the inclusion criteria will be included in this randomized, controlled, single blind and prospectively planned study. At the beginning of the study, 40 hemiplegic CP patients who meet the inclusion criteria will be randomized into two groups according to the random order created by the computer program after being numbered according to the order of application to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Pediatric Rehabilitation Unit. Upper extremity rehabilitation (bimanually 3 days a week for 6 weeks and 45 minutes per session) and physiotherapy (TG: Treatment Group) will be given to the first group accompanied by virtual reality, and only physiotherapy (CG: Control Group) will be given to the second group.
When the power analysis was performed to calculate the number of patients and when the results obtained from other studies were taken into account, it was concluded that at least 18 patients should be included in each group to obtain 0.95 power at 95% confidence interval. Considering that few people will be excluded from the study during the study, it was found appropriate to include 20 patients in each group and to start the study with a total of 40 people. Before starting the study, the patients will be informed about the study and their consent will be obtained and demographic characteristics such as age, height and weight will be evaluated.
Participants and their parents will be informed in writing and verbally about the purpose, duration and method of application of the research, and the "Informed Consent Form" will be signed after their consent is obtained.
The study is planned to be carried out in a single center in the Department of Physical Medicine and Rehabilitation of Istanbul University Istanbul Medical Faculty.
The virtual reality technology to be used in the study has temporary side effects such as nausea, vomiting, and dizziness, and side effects to increase epileptic seizures. For this reason, patients with uncontrolled epileptic seizures were excluded from the study. If effects such as nausea, vomiting and dizziness develop during the intervention, the session will be terminated and symptomatic treatment will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The virtual reality group will be given upper extremity rehabilitation via virtual reality glasses (3 days a week for 6 weeks and 45 minutes each session) and upper extremity exercises 2 days a week, while the control group will only be given upper extremity exercises 2 days a week.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual reality mediated upper extremity rehabilitation, Other: Classical exercise therapy for upper extremitiesTo the virtual reality group; In addition to upper extremity exercises applied 2 days a week, upper extremity rehabilitation via virtual reality glasses will be performed 3 days a week for 6 weeks and each session will be 45 minutes. |
| Control Group | Active comparator | Other: Classical exercise therapy for upper extremitiesUpper extremity exercises will be applied to the participants in the control group 2 days a week for 6 weeks. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Having been diagnosed with hemiplegic CP by a specialist pediatric neurologist,
- Being between the ages of 5-12,
- Following the child's simple commands and participating in the given tasks,
- Being at the Gross Motor Function Classification System (KMFSS) Stage 1, 2 or 3,
- Being in Hand Skills Classification System (MACS) Stage 1, 2 or 3,
Key exclusion criteria (9 listed)
- Having uncontrollable epileptic seizures
- Significant contractures in the fingers, wrists, elbows and shoulders that prevent daily activities,
- Having serious vision and hearing problems,
- Cognitive impairments that prevent understanding and performing simple commands and tasks,
- Not being able to continue the treatment protocol due to the school program,
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 |
|---|---|---|
| Virtual reality mediated upper extremity rehabilitationGame-based exercise will be applied for different range of motion of the upper extremity. Gamified exercise program consisting of 4 different scenarios will be applied 3 days a week for 6 weeks to the patients in the virtual reality group. A session takes an average of 45 minutes. Games to be applied; 1. Finger flexion-extension (10 minutes / session) 2. Wrist flexion, extension, ulnar and radial deviation (10 minutes / session) 3. Forearm pronation and supination (10 minutes / session) 4. Elbow flexion-extension-shoulder internal and external rotation (15 minutes / session) will have scenarios controlled with. All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes. | Other | Virtual Reality Group |
| Classical exercise therapy for upper extremitiesAll patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes. | Other | Control Group, Virtual Reality Group |
Primary outcome
Assisting Hand Assessment (AHA)
Time frame: 12 weeks
AHA is a test that measures how patients with impaired upper extremity functions, such as hemiplegic CP or congenital brachial plexus injury, use the affected hand together with the healthy hand when playing with both hands. The AHA 5.0 version consists of 20 items that evaluate hand functions, and the raw score range is between 20 and 80 points. Higher scores indicate better hand function.
6 secondary outcomes
Joint Range of Motion Measurement
Time frame: 12 weeks
Modified Ashworth Scale
Time frame: 12 weeks
Tardieu Scale
Time frame: 12 weeks
ABILHAND-Kids
Time frame: 12 weeks
QUEST
Time frame: 12 weeks
KINDL
Time frame: 12 weeks
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 20 Mar 2023.
- Results publication: PubMed 28109566Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.
- Results publication: PubMed 26947315Cho C, Hwang W, Hwang S, Chung Y. Treadmill Training with Virtual Reality Improves Gait, Balance, and Muscle Strength in Children with Cerebral Palsy. Tohoku J Exp Med. 2016 Mar;238(3):213-8. doi: 10.1620/tjem.238.213.
- Results publication: PubMed 29088476Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
- Results publication: PubMed 31614990Ren Z, Wu J. The Effect of Virtual Reality Games on the Gross Motor Skills of Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 14;16(20):3885. doi: 10.3390/ijerph16203885.
- Results publication: PubMed 29442357Hung YC, Gordon AM. Virtual reality training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Apr;60(4):334-335. doi: 10.1111/dmcn.13699. Epub 2018 Feb 14. No abstract available.
- Results publication: PubMed 31557701Ayed I, Ghazel A, Jaume-I-Capo A, Moya-Alcover G, Varona J, Martinez-Bueso P. Vision-based serious games and virtual reality systems for motor rehabilitation: A review geared toward a research methodology. Int J Med Inform. 2019 Nov;131:103909. doi: 10.1016/j.ijmedinf.2019.06.016. Epub 2019 Jul 10.
- Derived from this study: PubMed 35687751Menekseoglu AK, Capan N, Arman S, Aydin AR. Effect of a Virtual Reality-Mediated Gamified Rehabilitation Program on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy: A Prospective, Randomized Controlled Study. Am J Phys Med Rehabil. 2023 Mar 1;102(3):198-205. doi: 10.1097/PHM.0000000000002060. Epub 2022 Jun 9.
- Individual participant dataSharing planned: No. The patient data kept in the study will be shared with other researchers in case of a possible scientific publication. Personal data of the patients will not be shared, data of primary and secondary outcome criteria will be shared.
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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 Resa Aydın, Prof. Dr. principal investigator
Istanbul University Istanbul Medicine Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality mediated upper extremity rehabilitation and Classical exercise therapy for upper extremities in people with Cerebral Palsy and Upper Extremity Paresis, run by Istanbul 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 7 inclusion and 9 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 20 Mar 2023. 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?
Assisting Hand Assessment (AHA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529343, which also lists 7 linked publications.
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 20 Mar 2023.