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

IRCCS Eugenio Medea

Status: Completed

Conditions: Rett Syndrome

Treatments: Device: GRAIL

Study type: Interventional

Funder types: Other

Identifiers

NCT05691582

885

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: Female

Ages: 6 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Single arm

Experimental group

Description:

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

Treatment:

Device: GRAIL