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

NCT ID: NCT05691582

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-04-15

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

Conditions

Rett Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: EXPERIMENTAL

GRAIL

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Countries

Italy

Other Identifiers

885

Identifier Type: -

Identifier Source: org_study_id