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

NCT05691582 | Completed

• 1 other identifier: 885
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. 1.Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill);
2. 2.time to prepare a set of body marker in order to execute a gait analysis;
3. 3.walking activity over treadmill, with immersive virtual reality;
4. 4.proprioceptive stimulatione provided by the GRAIL platform;
5. 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

Conditions

Rett Syndrome

Keywords

Virtual Reality; Rett Syndrome; walk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees

  immediately after the treatment

• Happiness index

  immediately after the treatment

Study Arms (1)

Single arm

EXPERIMENTAL

All the subjects recruited have 4 access to GRAIL, in 4 different day, to test their tolerability to the proposals

Device: GRAIL

Interventions

GRAIL DEVICE

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

Single arm

Eligibility Criteria

• Age: 6 Years - 35 Years
• Gender Eligibility Details: Rett Syndrome is an X chromosome-associated pathology that reveal almost exclusively in female subjects
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• subjects unable to walk and with a complete incapacity to undestand verbal directions

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Associazione Italiana Rett (AIRett) O.n.l.u.s.: collaborator

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Rett Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: January 20, 2023
• Study Start: July 1, 2021
• Primary Completion: March 22, 2022
• Study Completion: April 15, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

IT (1)