BTs Nirvana and Post-stroke Rehab

NCT03095560 | Completed

• 1 other identifier: BSVR
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose of the article: aim of the present study was to detect the differences between the presence or not of body shadows during a virtual reality (VR) training with BTS NIRVANA (BTsN). Materials and methods: In this pilot study, we enrolled 20 post-stroke rehabilitation inpatients, who underwent a neurocognitive-rehabilitative training consisting of 24 sessions (three times a week for 8 weeks) of BTsN. All the patients were randomized into two groups: Semi-immersive virtual training with (S-IVTSgroup) or without (S-IVTgroup) body shadows. Each participant was evaluated before (T0), and immediately (T1) after the end of the training by a skilled neuropsychologist through the administration of a complete battery, and by a skilled neurologist to assess motor functions.

Conditions

Virtual Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment Test (MoCA)

  Six months

Study Arms (2)

Semi-immersive virtual training with shadow (S-IVTS)

EXPERIMENTAL

All the participants underwent a neurocognitive-rehabilitative training consisting of 24 sessions of BTsN. Each treatment session lasted 45 minutes, and was repeated three times a week for 8 weeks. in the BTsN device used in the S-IVTS group the projector is located behind the patient, thus the shadow of the patient is projected on the screen.

Device: NIRVANA

Semi-immersive virtual training without shadow (S-IVT)

EXPERIMENTAL

All the participants underwent a neurocognitive-rehabilitative training consisting of 24 sessions of BTsN. Each treatment session lasted 45 minutes, and was repeated three times a week for 8 weeks. in the BTsN device used in the S-IVT group the projector is located in front of the patient and the shadow is not visible.

Device: NIRVANA

Interventions

NIRVANA DEVICE

Nirvana is the first device based on optoelectronic infrared sensors, though which the patient can simply interact through his movements. The rehabilitation exercises with audio-visual stimuli and feedback involve the perceptual-cognitive skills of patients, resulting in a motivational training. Several modes and increasing levels of difficulty characterize each exercise, so the therapist can use a pre-defined rehabilitative solution or new ones, according to patient's needs. The results achieved during rehabilitation allow the therapist to evaluate the patient's actual progress, and then to modify the rehabilitation program. The system is connected to a projector or a big screen (put in front of the patient), reproducing an interactive series of exercises (for trunk, upper and lower limbs, and cognition), thanks to an infrared video camera analyzing the patient's movements, it creates interactivity.

Semi-immersive virtual training with shadow (S-IVTS); Semi-immersive virtual training without shadow (S-IVT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• absence of disabling sensory alterations, severe psychiatric and other medical illness.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Related Publications (1)

• Russo M, De Luca R, Naro A, Sciarrone F, Aragona B, Silvestri G, Manuli A, Bramanti A, Casella C, Bramanti P, Calabro RS. Does body shadow improve the efficacy of virtual reality-based training with BTS NIRVANA?: A pilot study. Medicine (Baltimore). 2017 Sep;96(38):e8096. doi: 10.1097/MD.0000000000008096.

  PMID: 28930852 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 29, 2017
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03