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

• ClinicalTrials.gov Identifier: NCT05691582
• Recruitment Status: Completed
• First Posted: January 20, 2023
• Last Update Posted: January 20, 2023
• Sponsor: IRCCS Eugenio Medea
• Collaborator: Associazione Italiana Rett (AIRett) O.n.l.u.s.
• Information provided by (Responsible Party): IRCCS Eugenio Medea

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:

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

Condition or disease	Intervention/treatment	Phase
Rett Syndrome	Device: GRAIL	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
• Actual Study Start Date: July 1, 2021
• Actual Primary Completion Date: March 22, 2022
• Actual Study Completion Date: April 15, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: Single arm; All the subjects recruited have 4 access to GRAIL, in 4 different day, to test their tolerability to the proposals

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees [ Time Frame: immediately after the treatment ]

   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.

2. Happiness index [ Time Frame: immediately after the treatment ]
   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

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 35 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Rett Syndrome is an X chromosome-associated pathology that reveal almost exclusively in female subjects
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

IRCCS E. Medea

Bosisio Parini, Lecco, Italy, 23842

Sponsors and Collaborators

IRCCS Eugenio Medea

Associazione Italiana Rett (AIRett) O.n.l.u.s.

More Information

• Responsible Party: IRCCS Eugenio Medea
• ClinicalTrials.gov Identifier: NCT05691582
• Other Study ID Numbers: 885
• First Posted: January 20, 2023
• Last Update Posted: January 20, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IRCCS Eugenio Medea:

Virtual Reality; Rett Syndrome; walk

Additional relevant MeSH terms:

Rett Syndrome; Syndrome; Disease; Pathologic Processes; Mental Retardation, X-Linked; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Heredodegenerative Disorders, Nervous System