Hemiplegic Cerebral PalsyNCT06317935
The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP
A study testing ArmeoSenso and Traditional Rehabilitation in people with Hemiplegic Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy. The research is a randomized controlled, cross-over study. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- ArmeoSenso and Traditional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2024to 29 Oct 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Having a diagnosis of hemiplegic SP
- Being between the ages of 6-12
- Not having any fixed contracture in the upper extremity
- According to the Modified Ashworth Scale, the upper extremity spasticity value is at the level of 1,1+,2 or 3
- Being at level I, II or III according to the Gross Motor Function Classification System (GMFCS)
- Being at level II or III according to the Manual Ability Classification System (MACS)
Show all 11Show fewer
- Being at level I, II or III according to the Communication Function Classification System (CFCS)
- Being within the normal cognitive level according to the Modified Pediatrics Mini Mental Test score
- Being at level I, II or III according to the Eating and Drinking Ability Classification System (EDACS)
- Being at level I, II or III according to the Visual Function Classification System for Children with Cerabral Palsy (VFCS)
- Volunteering to participate in the study
Who cannot join
- Having botolinum toxin injection within the last 6 months
- Having undergone a surgical procedure within the last 1 year
- Fracture, trauma, etc. in the upper extremity. to live
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Multiple Locations, Ankara, 06000
Başak Karadağ, MSc, +905059462128, basakhacettepe@hotmail.com
Berke Aras, Ass. Prof., +90365851518, drberkearas@gmail.com
About this study
Official title: The Effect of Virtual Reality Intervention on Upper Extremity Functioning and Perceived Independence in Daily Life in Children With Hemiplegic Cerebral Palsy
The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.
The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.
Read more
Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.
The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.
After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.
Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention.
Read the detailed description
The sample group of the research is children between the ages of 6-12, diagnosed with hemiplegic cerebral palsy, who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and their families.
Statistical power analysis was performed to calculate the number of people required to be included in the study. Statistical power analysis was performed with G*Power v.3.1.9.7 software. In the analysis, the Type 1 error margin (α) was accepted as 5% and the desired statistical power (1-β) was accepted as 0.80. In order to carry out the analysis, randomized controlled studies in the literature on the subject that reported effect sizes were examined. Studies have found that in virtual reality-based interventions applied to children with cerebral palsy, strong to very strong effect sizes were reported between intervention and control groups in variables such as upper extremity functions and performance in daily living activities (4, 7-11). When calculations were made using the strong effect size (Cohen's d = 0.80) in the sample size analysis, it was determined that the smallest sample size that needed to be reached for both groups was 26. Therefore, a total of 52 people were included in the study.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- ArmeoSenso, Traditional Rehabilitation
- Keywords
- Virtual Reality, Upper Extremity, Hemiplegic Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmeoSensoOther
ArmeoSenso is an upper extremity virtual reality application with three motion sensors and one hand grip sensor. The device detects the person's body, arm, forearm and hand movements and displays the reflection of the movements on the screen. The application includes studies on upper extremity functions.
Traditional RehabilitationOther
It includes traditional occupational therapy and physiotherapy approaches.
| Study group | Role | What they receive |
|---|---|---|
| ArmeoSenso | Other | ArmeoSenso virtual reality application will be applied to group A in the 0-3 weeks of the study and to group B in the 3-6 weeks. Receives: Other: ArmeoSenso; Other: Traditional Rehabilitation |
| Traditional rehabilitation | Other | Traditional rehabilitation (physiotherapy and occupational therapy) approaches will continue to be applied to groups A and B at all stages of the research. Receives: Other: Traditional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP.
The independence levels perceived by children with hemiplegic CP in daily life will be evaluated with the Children's Hand Use Experience Questionnaire.
Measured: At the end of the 6th week
The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP.
The impact on the upper extremity functionality of children with hemiplegic CP in daily life will be evaluated with the Pediatric Motor Activity Log-Revised test.
Measured: At the end of the 6th week
Secondary outcomes (1)
Dosimetry of virtual reality applications
As suggested in further research, examining the dosimetric properties of virtual reality applications such as frequency and duration and comparing them with other studies.
Measured: At the end of the 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start23 Apr 2024 (estimated)
- Primary completion29 Jun 2024 (estimated)
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method. Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks. The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Basak Karadag, Hacettepe University
- Investigators
- Başak Karadağ, MSc, Principal investigator, Ankara City Hospital BilkentMeral Huri, Professor, Study director, Hacettepe UniversityBerke Aras, Ass.Prof., Principal investigator, Ankara City Hospital BilkentÖzge Tezen, MD, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317935
- Sponsor's protocol ID
- HU-ERG-BK-01
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the principal investigator can access information about individuals; other researchers will not be able to access this information due to blinding.
Publications
Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
PubMed 24819682Goyal C, Vardhan V, Naqvi W. Virtual Reality-Based Intervention for Enhancing Upper Extremity Function in Children With Hemiplegic Cerebral Palsy: A Literature Review. Cureus. 2022 Jan 28;14(1):e21693. doi: 10.7759/cureus.21693. eCollection 2022 Jan.
PubMed 35237486
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Intervention on Upper Extremity Functioning and Perceived Independence in Daily Life in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06317935
- Acronym / sponsor ID
- HU-ERG-BK-01
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Virtual Reality, Upper Extremity, Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 23 Apr 2024 (estimated)
- Primary completion
- 29 Jun 2024 (estimated)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 19 Mar 2024 (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.
The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.
The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.
Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.
The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.
After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.
Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention.
Detailed description
The sample group of the research is children between the ages of 6-12, diagnosed with hemiplegic cerebral palsy, who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and their families.
Statistical power analysis was performed to calculate the number of people required to be included in the study. Statistical power analysis was performed with G*Power v.3.1.9.7 software. In the analysis, the Type 1 error margin (α) was accepted as 5% and the desired statistical power (1-β) was accepted as 0.80. In order to carry out the analysis, randomized controlled studies in the literature on the subject that reported effect sizes were examined. Studies have found that in virtual reality-based interventions applied to children with cerebral palsy, strong to very strong effect sizes were reported between intervention and control groups in variables such as upper extremity functions and performance in daily living activities (4, 7-11). When calculations were made using the strong effect size (Cohen's d = 0.80) in the sample size analysis, it was determined that the smallest sample size that needed to be reached for both groups was 26. Therefore, a total of 52 people were included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method. Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks. The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| ArmeoSenso | Other | Other: ArmeoSenso, Other: Traditional RehabilitationArmeoSenso virtual reality application will be applied to group A in the 0-3 weeks of the study and to group B in the 3-6 weeks. |
| Traditional rehabilitation | Other | Other: Traditional RehabilitationTraditional rehabilitation (physiotherapy and occupational therapy) approaches will continue to be applied to groups A and B at all stages of the research. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- - Having a diagnosis of hemiplegic SP
- Being between the ages of 6-12
- Not having any fixed contracture in the upper extremity
- According to the Modified Ashworth Scale, the upper extremity spasticity value is at the level of 1,1+,2 or 3
- Being at level I, II or III according to the Gross Motor Function Classification System (GMFCS)
Key exclusion criteria (3 listed)
- Having botolinum toxin injection within the last 6 months
- Having undergone a surgical procedure within the last 1 year
- Fracture, trauma, etc. in the upper extremity. to live
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 |
|---|---|---|
| ArmeoSensoArmeoSenso is an upper extremity virtual reality application with three motion sensors and one hand grip sensor. The device detects the person's body, arm, forearm and hand movements and displays the reflection of the movements on the screen. The application includes studies on upper extremity functions. | Other | ArmeoSenso |
| Traditional RehabilitationIt includes traditional occupational therapy and physiotherapy approaches. | Other | ArmeoSenso, Traditional rehabilitation |
Primary outcome
The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP.
Time frame: At the end of the 6th week
The independence levels perceived by children with hemiplegic CP in daily life will be evaluated with the Children's Hand Use Experience Questionnaire.
The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP.
Time frame: At the end of the 6th week
The impact on the upper extremity functionality of children with hemiplegic CP in daily life will be evaluated with the Pediatric Motor Activity Log-Revised test.
1 secondary outcome
Dosimetry of virtual reality applications
Time frame: At the end of the 6th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 24819682Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
- Background: PubMed 35237486Goyal C, Vardhan V, Naqvi W. Virtual Reality-Based Intervention for Enhancing Upper Extremity Function in Children With Hemiplegic Cerebral Palsy: A Literature Review. Cureus. 2022 Jan 28;14(1):e21693. doi: 10.7759/cureus.21693. eCollection 2022 Jan.
- Individual participant dataSharing planned: No. Only the principal investigator can access information about individuals; other researchers will not be able to access this information due to blinding.
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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.
Başak Karadağ, MSc principal investigator
Ankara City Hospital Bilkent
Meral Huri, Professor study director
Hacettepe University
Berke Aras, Ass.Prof. principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArmeoSenso and Traditional Rehabilitation in people with Hemiplegic Cerebral Palsy, run by Hacettepe 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 11 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Başak Karadağ, MSc. (+905059462128, karadagbasak@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP. (time frame: At the end of the 6th week). The study lists 2 primary outcomes in all. 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 NCT06317935, which also lists 2 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 19 Mar 2024.