Back to resultsTolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
Primary Purpose
Rett Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
GRAIL
Sponsored by
About this trial
This is an interventional device feasibility trial for Rett Syndrome focused on measuring Virtual Reality, Rett Syndrome, walk
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: subjects unable to walk and with a complete incapacity to undestand verbal directions
Sites / Locations
- IRCCS E. Medea
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
All the subjects recruited have 4 access to GRAIL, in 4 different day, to test their tolerability to the proposals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT05691582
First Posted
May 26, 2022
Last Updated
January 19, 2023
Sponsor
IRCCS Eugenio Medea
Collaborators
Associazione Italiana Rett (AIRett) O.n.l.u.s.
1. Study Identification
Unique Protocol Identification Number
NCT05691582
Brief Title
Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
Official Title
Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
Collaborators
Associazione Italiana Rett (AIRett) O.n.l.u.s.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rett Syndrome
Keywords
Virtual Reality, Rett Syndrome, walk
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
All the subjects recruited have 4 access to GRAIL, in 4 different day, to test their tolerability to the proposals
Intervention Type
Device
Intervention Name(s)
GRAIL
Intervention Description
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
Primary Outcome Measure Information:
Title
Total score on the Suitability Evaluation Questionnaire (SEQ)
Description
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.
Time Frame
immediately after the treatment
Secondary Outcome Measure Information:
Title
Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees
Description
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.
Time Frame
immediately after the treatment
Title
Happiness index
Description
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
Time Frame
immediately after the treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Rett Syndrome is an X chromosome-associated pathology that reveal almost exclusively in female subjects
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
subjects unable to walk and with a complete incapacity to undestand verbal directions
Facility Information:
Facility Name
IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
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