Cerebral PalsyNCT04483388
Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy
A study testing Training with Virtual Reality and Conventional Training in people with Cerebral Palsy, run by Universidade Federal do Rio Grande do Norte.
Trial summary
The objective of this study was to evaluate the effects of training with Virtual Reality in the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol consisted of two days of training and 1 revaluation. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Training with Virtual Reality and Conventional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Oct 2014
- 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
- A diagnosis of cerebral palsy spastic hemiparesis;
- Aged 6 to 12 years old;
- Preserved cognition to understand instructions;
- Present no significant auditory and visual deficits;
- The affected upper limb classified in levels II and III Rating System Manual (MACS, English Manual Abilities Classification System). The level II corresponds to children who are able to handle the majority of objects with low quality and / or speed of movement, while at level III are those that manipulate objects with difficulty and low speed, requiring assistance organization of activity. Spasticity ranked among the levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic surgeries, or have made use of botulinum toxin for less than six months, not presenting seizures, controlled medication.
Who cannot join
- Presence of pain or discomfort during the course of the training;
- Refusal to follow commands and instructions and discontinuity of interventions.
About this study
Official title: Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy: Crossover Randomized Clinical Trial
The objective of this study was to evaluate the effects of training with Virtual Reality in the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week no significant changes were observed for the angular variables and space-time between groups. The Virtual Reality used for intervention to improve upper arm function in children with Cerebral Palsy is still a relatively new method.
Read the detailed description
Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP) spastic hemiparetic restricts their participation in social activities. Virtual reality (VR) has shown promising results in functional recovery of this population, however, few studies have evaluated its effectiveness in the reaching of motion of these children. Objective: To assess the effects of training with VR in the movement range of children with CP spastic hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of motion, grip strength, functional performance and disability. Kinematic analysis of the upper limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week. Data were analyzed using SPSS 20.0 (Statistical Package for Social Science) assigning a 5% significance level. The kinematic variables were analyzed by two-way ANOVA for repeated measures.
- Conditions
- Cerebral Palsy
- Being tested
- Training with Virtual Reality, Conventional Training
- Keywords
- Cerebral Palsy, Rehabilitation, Physiotherapy, Virtual Reality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with Virtual RealityOther
Also called Training A
Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.
Conventional TrainingOther
Also called Training B
It was done five types of exercises following to the protocol:
Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).
| Study group | Role | What they receive |
|---|---|---|
| Group AB | Other | After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training. Receives: Other: Training with Virtual Reality; Other: Conventional Training |
| Group BA | Other | After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality. Receives: Other: Training with Virtual Reality; Other: Conventional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic upper arm evaluation of children with cerebral palsy
We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Feitoza do Nascimento, Universidade Federal do Rio Grande do Norte
- Investigators
- Ana Raquel Lindquist, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483388
- Sponsor's protocol ID
- 12649913.0.0000.5537
- Status last verified
- Feb 2015
- First submitted
- 11 Aug 2015
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
PubMed 12509602Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
PubMed 16108461Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
PubMed 12227614Coleman A, Weir KA, Ware RS, Boyd RN. Relationship between communication skills and gross motor function in preschool-aged children with cerebral palsy. Arch Phys Med Rehabil. 2013 Nov;94(11):2210-7. doi: 10.1016/j.apmr.2013.03.025. Epub 2013 Apr 11.
PubMed 23583864Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.
PubMed 23433275Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
PubMed 17895352Chiu HC, Ada L, Lee HM. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial. Clin Rehabil. 2014 Oct;28(10):1015-24. doi: 10.1177/0269215514533709. Epub 2014 May 21.
PubMed 24849793Chen 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 24819682
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy: Crossover Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04483388
- Acronym / sponsor ID
- 12649913.0.0000.5537
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Rehabilitation, Physiotherapy, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Jul 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.
The objective of this study was to evaluate the effects of training with Virtual Reality in the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week no significant changes were observed for the angular variables and space-time between groups. The Virtual Reality used for intervention to improve upper arm function in children with Cerebral Palsy is still a relatively new method.
Detailed description
Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP) spastic hemiparetic restricts their participation in social activities. Virtual reality (VR) has shown promising results in functional recovery of this population, however, few studies have evaluated its effectiveness in the reaching of motion of these children. Objective: To assess the effects of training with VR in the movement range of children with CP spastic hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of motion, grip strength, functional performance and disability. Kinematic analysis of the upper limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week. Data were analyzed using SPSS 20.0 (Statistical Package for Social Science) assigning a 5% significance level. The kinematic variables were analyzed by two-way ANOVA for repeated measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group AB | Other | Other: Training with Virtual Reality, Other: Conventional TrainingAfter randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training. |
| Group BA | Other | Other: Training with Virtual Reality, Other: Conventional TrainingAfter randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A diagnosis of cerebral palsy spastic hemiparesis;
- Aged 6 to 12 years old;
- Preserved cognition to understand instructions;
- Present no significant auditory and visual deficits;
- The affected upper limb classified in levels II and III Rating System Manual (MACS, English Manual Abilities Classification System). The level II corresponds to children who are able to handle the majority of objects with low quality and / or speed of movement, while at level III are those that manipulate objects with difficulty and low speed, requiring assistance organization of activity. Spasticity ranked among the levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic surgeries, or have made use of botulinum toxin for less than six months, not presenting seizures, controlled medication.
Key exclusion criteria (2 listed)
- Presence of pain or discomfort during the course of the training;
- Refusal to follow commands and instructions and discontinuity of interventions.
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 |
|---|---|---|
| Training with Virtual RealityAlso: Training AComputed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports. | Other | Group AB, Group BA |
| Conventional TrainingAlso: Training BIt was done five types of exercises following to the protocol: Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training). | Other | Group AB, Group BA |
Primary outcome
Kinematic upper arm evaluation of children with cerebral palsy
Time frame: 4 months
We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.
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 23 Jul 2020.
- Background: PubMed 12509602Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
- Background: PubMed 16108461Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Background: PubMed 12227614Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
- Background: PubMed 23583864Coleman A, Weir KA, Ware RS, Boyd RN. Relationship between communication skills and gross motor function in preschool-aged children with cerebral palsy. Arch Phys Med Rehabil. 2013 Nov;94(11):2210-7. doi: 10.1016/j.apmr.2013.03.025. Epub 2013 Apr 11.
- Results publication: PubMed 23433275Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.
- Results publication: PubMed 17895352Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
- Results publication: PubMed 24849793Chiu HC, Ada L, Lee HM. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial. Clin Rehabil. 2014 Oct;28(10):1015-24. doi: 10.1177/0269215514533709. Epub 2014 May 21.
- Results publication: 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.
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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.
Ana Raquel Lindquist, PhD principal investigator
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A study testing Training with Virtual Reality and Conventional Training in people with Cerebral Palsy, run by Universidade Federal do Rio Grande do Norte.
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 5 inclusion and 2 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Kinematic upper arm evaluation of children with cerebral palsy (time frame: 4 months). 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 NCT04483388, which also lists 8 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 23 Jul 2020.