Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome

Rett Syndrome Clinical Trial

Official title:

Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691582
• Other study ID #: 885
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: January 2023
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. time to prepare a set of body marker in order to execute a gait analysis;

3. walking activity over treadmill, with immersive virtual reality;

4. proprioceptive stimulatione provided by the GRAIL platform;

5. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 15, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 6 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Rett Syndrome
• Syndrome

Intervention

Device:
• GRAIL
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

Locations

Country	Name	City	State
Italy	IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	Associazione Italiana Rett (AIRett) O.n.l.u.s.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after the treatment
Secondary	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.	immediately after the treatment
Secondary	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	immediately after the treatment