Rett SyndromeNCT05691582
Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
A study testing GRAIL in people with Rett Syndrome, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The main goal of this study is to investigate the tolerability to the use of the GRAIL system in subjects affected by Rett syndrome, particularly referred to: 1. Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill); 2. Read more about this study
- Who is it for?
- Ages 6 to 35 years, women only
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- GRAIL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 15 Apr 2022
- 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 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects affected by Rett Syndrome that are able to walk with hands support (corresponding to a score ranging from 1 to 3 in item 8 of Rett Syndrome Gross Motor Scale)
Who cannot join
- subjects unable to walk and with a complete incapacity to undestand verbal directions
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to investigate the tolerability to the use of the GRAIL system in subjects affected by Rett syndrome, particularly referred to:
- Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill);
- time to prepare a set of body marker in order to execute a gait analysis;
- walking activity over treadmill, with immersive virtual reality;
- proprioceptive stimulatione provided by the GRAIL platform;
- cognitive-attentive span time to the activity proposed. The secondary goal is to understand if a training that avail of treadmill and virtual reality would be useful in the future in improving gait characteristics in subjects affected by Rett syndrome
- Conditions
- Rett Syndrome
- Being tested
- GRAIL
- Keywords
- Virtual Reality, Rett Syndrome, walk
- Medical subject headings
- Rett Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAILDevice
The subjects experiment GRAIL virtual reality for three days, during which they deal with 4 different activities.
In the first activity subjects are required to ask over the treadmill in a snow environment.
in the second they are required to stand over the moving platform in a simulation of a boat pitch.
in the third they have to walk over a bridge with a slope. in the fourth the subjects are required to try so interact with virtual reality and to ski between snowman.
if it is possible, on the last day a gait analysis is executed
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All the subjects recruited have 4 access to GRAIL, in 4 different day, to test their tolerability to the proposals Receives: Device: GRAIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score on the Suitability Evaluation Questionnaire (SEQ)
it is a subjective questionnaire assessing the suitability of the intervention. This is not a health outcome. Indeed SEQ is a questionnaire designed for virtual reality, composed by 13 questions, with a response graded on a 5-point Likert Scale, and a last open question.
It measures measures enjoyment, sense of being in the system, feeling of success and control, realism, easy-to-understand instructions and general discomfort; furthermore it is aimed to detect issues frequently associated with virtual rehabilitation systems, like dizziness or nausea symptoms, eye discomfort, disorientation or confusion symptoms and sense of progress in rehabilitation. Finally, it evaluates the perceived difficulty of the task and the observed difficulty related with the physical interface used in the system.
Measured: immediately after the treatment
Secondary outcomes (2)
Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees
The gait analysis assessment is conducted over the GRAIL (Gait Real-time Analysis Interactive Lab) system .
It is a laboratory suitable for motion analysis and VR-based rehabilitation. It is composed by a treadmill, provided with two belts that can be driven at different speeds and it is equipped with integrated force platforms. An immersive semicircular screen is placed in front of the treadmill, where VR environments, synchronized with the treadmill movement, are projected. The system uses a Vi-con motion capture system and 3 video cameras to perform motion detection and gait analysis: accordingly, 25 markers were placed on specific anatomical landmarks of the body. Each participant performed a ten-minute familiarization phase and then about 40 steps were acquired.
Spatiotemporal parameters, such as walking velocity, stance duration, stride length and step width, and kinematic parameters of pelvis, hip, knee and ankle were computed.
Measured: immediately after the treatment
Happiness index
The parameter comes from a taxonomy based on the analysis of the communication of subjects with profound intellectual disabilities. it consists of 12 categories, and each can receive the score "1" when present or "0" when absent
Measured: immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jul 2021
- Primary completion22 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana Rett (AIRett) O.n.l.u.s.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691582
- Sponsor's protocol ID
- 885
- Status last verified
- Jan 2023
- First submitted
- 26 May 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
- ClinicalTrials.gov ID
- NCT05691582
- Acronym / sponsor ID
- 885
- Conditions
- Rett Syndrome
- Keywords
- Virtual Reality, Rett Syndrome, walk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Associazione Italiana Rett (AIRett) O.n.l.u.s.
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 20 Jan 2023 (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 main goal of this study is to investigate the tolerability to the use of the GRAIL system in subjects affected by Rett syndrome, particularly referred to:
- Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill);
- time to prepare a set of body marker in order to execute a gait analysis;
- walking activity over treadmill, with immersive virtual reality;
- proprioceptive stimulatione provided by the GRAIL platform;
- cognitive-attentive span time to the activity proposed. The secondary goal is to understand if a training that avail of treadmill and virtual reality would be useful in the future in improving gait characteristics in subjects affected by Rett syndrome
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: GRAILAll the subjects recruited have 4 access to GRAIL, in 4 different day, to test their tolerability to the proposals |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- subjects affected by Rett Syndrome that are able to walk with hands support (corresponding to a score ranging from 1 to 3 in item 8 of Rett Syndrome Gross Motor Scale)
Key exclusion criteria (1 listed)
- subjects unable to walk and with a complete incapacity to undestand verbal directions
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 |
|---|---|---|
| GRAILThe subjects experiment GRAIL virtual reality for three days, during which they deal with 4 different activities. In the first activity subjects are required to ask over the treadmill in a snow environment. in the second they are required to stand over the moving platform in a simulation of a boat pitch. in the third they have to walk over a bridge with a slope. in the fourth the subjects are required to try so interact with virtual reality and to ski between snowman. if it is possible, on the last day a gait analysis is executed | Device | Single arm |
Primary outcome
Total score on the Suitability Evaluation Questionnaire (SEQ)
Time frame: immediately after the treatment
it is a subjective questionnaire assessing the suitability of the intervention. This is not a health outcome. Indeed SEQ is a questionnaire designed for virtual reality, composed by 13 questions, with a response graded on a 5-point Likert Scale, and a last open question. It measures measures enjoyment, sense of being in the system, feeling of success and control, realism, easy-to-understand instructions and general discomfort; furthermore it is aimed to detect issues frequently associated with virtual rehabilitation systems, like dizziness or nausea symptoms, eye discomfort, disorientation or confusion symptoms and sense of progress in rehabilitation. Finally, it evaluates the perceived difficulty of the task and the observed difficulty related with the physical interface used in the system.
2 secondary outcomes
Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees
Time frame: immediately after the treatment
Happiness index
Time frame: immediately after the treatment
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 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRAIL in people with Rett Syndrome, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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 Jan 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 Italy. 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?
Total score on the Suitability Evaluation Questionnaire (SEQ) (time frame: immediately after the treatment). 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 20 Jan 2023.