Cerebral PalsyNCT03348943
Motor Learning in People With Cerebral Palsy by Using Virtual Reality.
A study testing Right hemiparesis, right upper limb., Right hemiparesis, left upper limb and Left hemiparesis, left upper limb in people with Cerebral Palsy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Cerebral Palsy (CP) is a group of permanent disorders that affect movement and posture due to a non-progressive lesion in the immature brain occurring in fetal brain development or in infancy. These disorders are often associated with changes in sensation, learning, body perception, communication and behavior. Read more about this study
- Who is it for?
- Ages 6 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Right hemiparesis, right upper limb., Right hemiparesis, left upper limb and Left hemiparesis, left upper limb
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2017to 1 Sep 2017
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- classification of gross motor function with levels I and II according to the Gross Motor Function Classification System (GMFCS),
- MACS (Manual Ability Classification System) classification between levels I and II.
Who cannot join
- over 20 years;
- comorbidities that prevent the accomplishment of the activity;
- people with significant visual and cognitive impairment;
- those who have undergone chemical blockade or upper limb surgery for less than six months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
São Paulo, 03828-000
About this study
Official title: Comparative Analysis of Motor Performance in People With Cerebral Palsy (Spastic Hemiparesis) by Virtual Task.
Cerebral Palsy (CP) is a group of permanent disorders that affect movement and posture due to a non-progressive lesion in the immature brain occurring in fetal brain development or in infancy. These disorders are often associated with changes in sensation, learning, body perception, communication and behavior. People with CP present variable difficulties in muscle action. With increasing access to computer-aided accessibility, rehabilitation programs have increasingly used virtual reality (VR) environments to provide functional tasks. Virtual reality research in individuals with cerebral palsy has demonstrated improvements in gross motor functions and functional disabilities in mobility, and is a good device for rehabilitation. The present research is a cross-sectional study. For this study 40 individuals aged over six years (with task comprehension) of both gender who have a clinical diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated. Thus, the present study aims to compare the motor function of the committed and uncommitted body side by performing tasks in virtual reality.
Read the detailed description
METHOD The present research is a cross-sectional study. The study will be carried out at the School of Special Education Don Bosco, Rio Branco, Acre.
PARTICIPANTS (CASE) For this study 40 individuals aged over six years (with task comprehension) of both gender who have a clinical diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated.
STUDY DESIGN The individuals selected will be divided according to the affected body side, forming a first group categorized by RH (Right Hemiparetic) and a second LH (Left Hemiparetic), and for the accomplishment of the activity in the RH group half will start the task with the affected side and than with the unaffected side and the same will be reproduced in the LH group. Before performing the matching Timing task, individuals will perform a simple reaction time (RT) task, with 14 repetitions in each task.
Next, they will perform 20 attempts of the Timing task in the acquisition phase (0.5 second speed between the firings of each sphere - level 4), after 10 minutes without contact with the task the subjects will carry out 5 attempts for the Retention phase at the same speed as the acquisition phase. Then the subjects will perform 5 more attempts for the transfer phase with change in the speed of the task (0.25 seconds between the firings of each sphere - level 5). After the task is finished, the TR will be applied again.
INSTRUMENTS Timing Software Coincident For the data collection will be used a software of games created in partnership with the group of Information Systems of the School of Arts, Sciences and Humanities, EACH-USP. The game proposes a Coincident Timing task, which displays on the computer screen 10 spheres that light up (red light) in sequence until reaching the last ball that is considered the target (Green light). The participant can have immediate feedback of correctness or error of the task through different sounds (Auditory Interaction) and through visual images (Visual Interaction) that change color previously demonstrated to them.
Software TRT_S (Simple Reaction Time) Other software used was TRT_S2012. Which was constructed and validated by Crocetta et al. The software proposes a simple TRT test consisting of the appearance of a yellow square (parameterizable) in the center of the monitor at predefined time intervals (ranging from 1.5 to 6.5 ms - these intervals were identical in both Software) and, when the stimulus is applied, the participant should react as quickly as possible by pressing the spacebar on the computer keyboard.
Procedure and design Participants will perform the task individually in a quiet room, with only the experimenter, who will provide the instructions. The computer monitor will be positioned on a desk. Participants will remain seated in the chair with height adjusted according to the needs of each. In addition, a footrest will be available if needed. The functional assessment scales will be performed at the beginning of the research, the experimenter will explain the task verbally and perform a demonstration of the game's functioning and interfaces (Kinect for Windows®, touch the computer key or touchscreen).
- Conditions
- Cerebral Palsy
- Being tested
- Right hemiparesis, right upper limb., Right hemiparesis, left upper limb, Left hemiparesis, left upper limb, Left hemiparesis, right upper limb
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right hemiparesis, right upper limb.Behavioural
Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
Right hemiparesis, left upper limbBehavioural
Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.
Left hemiparesis, left upper limbBehavioural
Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
Left hemiparesis, right upper limbBehavioural
Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.
| Study group | Role | What they receive |
|---|---|---|
| Right hemiparesis, right upper limb | Active comparator | Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb. Receives: Behavioral: Right hemiparesis, right upper limb. |
| Right hemiparesis, left upper limb | Experimental | Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb. Receives: Behavioral: Right hemiparesis, left upper limb |
| Left hemiparesis, left upper limb | Active comparator | Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb. Receives: Behavioral: Left hemiparesis, left upper limb |
| Left hemiparesis, right upper limb | Experimental | Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb. Receives: Behavioral: Left hemiparesis, right upper limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in performance of the Coincident Timing task between participants with right hemiparesis and participants with left hemiparesis
There will be differences between right and left hemiparesis regarding coincident timing (e.g. patients with left hemiparesis will have a worse time in milliseconds that patients with right hemiparesis).
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start15 Apr 2017
- Primary completion1 Jul 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348943
- Sponsor's protocol ID
- 61384416.3.0000.8028
- Status last verified
- Nov 2017
- First submitted
- 1 Jun 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Motor Performance in People With Cerebral Palsy (Spastic Hemiparesis) by Virtual Task.
- ClinicalTrials.gov ID
- NCT03348943
- Acronym / sponsor ID
- 61384416.3.0000.8028
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 21 Nov 2017 (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 group of permanent disorders that affect movement and posture due to a non-progressive lesion in the immature brain occurring in fetal brain development or in infancy. These disorders are often associated with changes in sensation, learning, body perception, communication and behavior. People with CP present variable difficulties in muscle action. With increasing access to computer-aided accessibility, rehabilitation programs have increasingly used virtual reality (VR) environments to provide functional tasks. Virtual reality research in individuals with cerebral palsy has demonstrated improvements in gross motor functions and functional disabilities in mobility, and is a good device for rehabilitation. The present research is a cross-sectional study. For this study 40 individuals aged over six years (with task comprehension) of both gender who have a clinical diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated. Thus, the present study aims to compare the motor function of the committed and uncommitted body side by performing tasks in virtual reality.
Detailed description
METHOD The present research is a cross-sectional study. The study will be carried out at the School of Special Education Don Bosco, Rio Branco, Acre.
PARTICIPANTS (CASE) For this study 40 individuals aged over six years (with task comprehension) of both gender who have a clinical diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated.
STUDY DESIGN The individuals selected will be divided according to the affected body side, forming a first group categorized by RH (Right Hemiparetic) and a second LH (Left Hemiparetic), and for the accomplishment of the activity in the RH group half will start the task with the affected side and than with the unaffected side and the same will be reproduced in the LH group. Before performing the matching Timing task, individuals will perform a simple reaction time (RT) task, with 14 repetitions in each task.
Next, they will perform 20 attempts of the Timing task in the acquisition phase (0.5 second speed between the firings of each sphere - level 4), after 10 minutes without contact with the task the subjects will carry out 5 attempts for the Retention phase at the same speed as the acquisition phase. Then the subjects will perform 5 more attempts for the transfer phase with change in the speed of the task (0.25 seconds between the firings of each sphere - level 5). After the task is finished, the TR will be applied again.
INSTRUMENTS Timing Software Coincident For the data collection will be used a software of games created in partnership with the group of Information Systems of the School of Arts, Sciences and Humanities, EACH-USP. The game proposes a Coincident Timing task, which displays on the computer screen 10 spheres that light up (red light) in sequence until reaching the last ball that is considered the target (Green light). The participant can have immediate feedback of correctness or error of the task through different sounds (Auditory Interaction) and through visual images (Visual Interaction) that change color previously demonstrated to them.
Software TRT_S (Simple Reaction Time) Other software used was TRT_S2012. Which was constructed and validated by Crocetta et al. The software proposes a simple TRT test consisting of the appearance of a yellow square (parameterizable) in the center of the monitor at predefined time intervals (ranging from 1.5 to 6.5 ms - these intervals were identical in both Software) and, when the stimulus is applied, the participant should react as quickly as possible by pressing the spacebar on the computer keyboard.
Procedure and design Participants will perform the task individually in a quiet room, with only the experimenter, who will provide the instructions. The computer monitor will be positioned on a desk. Participants will remain seated in the chair with height adjusted according to the needs of each. In addition, a footrest will be available if needed. The functional assessment scales will be performed at the beginning of the research, the experimenter will explain the task verbally and perform a demonstration of the game's functioning and interfaces (Kinect for Windows®, touch the computer key or touchscreen).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Right hemiparesis, right upper limb | Active comparator | Behavioral: Right hemiparesis, right upper limb.Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb. |
| Right hemiparesis, left upper limb | Experimental | Behavioral: Right hemiparesis, left upper limbIndividuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb. |
| Left hemiparesis, left upper limb | Active comparator | Behavioral: Left hemiparesis, left upper limbIndividuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb. |
| Left hemiparesis, right upper limb | Experimental | Behavioral: Left hemiparesis, right upper limbIndividuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb. |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- classification of gross motor function with levels I and II according to the Gross Motor Function Classification System (GMFCS),
- MACS (Manual Ability Classification System) classification between levels I and II.
Key exclusion criteria (4 listed)
- over 20 years;
- comorbidities that prevent the accomplishment of the activity;
- people with significant visual and cognitive impairment;
- those who have undergone chemical blockade or upper limb surgery for less than six months
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 |
|---|---|---|
| Right hemiparesis, right upper limb.Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb. | Behavioural | Right hemiparesis, right upper limb |
| Right hemiparesis, left upper limbIndividuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb. | Behavioural | Right hemiparesis, left upper limb |
| Left hemiparesis, left upper limbIndividuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb. | Behavioural | Left hemiparesis, left upper limb |
| Left hemiparesis, right upper limbIndividuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb. | Behavioural | Left hemiparesis, right upper limb |
Primary outcome
Difference in performance of the Coincident Timing task between participants with right hemiparesis and participants with left hemiparesis
Time frame: 6 months.
There will be differences between right and left hemiparesis regarding coincident timing (e.g. patients with left hemiparesis will have a worse time in milliseconds that patients with right hemiparesis).
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 24 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Carlos BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right hemiparesis, right upper limb., Right hemiparesis, left upper limb and Left hemiparesis, left upper limb in people with Cerebral Palsy, run by University of Sao Paulo at 1 site in Brazil.
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 2 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 24 Nov 2017. 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 Brazil. 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?
Difference in performance of the Coincident Timing task between participants with right hemiparesis and participants with left hemiparesis (time frame: 6 months.). 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 24 Nov 2017.