BTs Nirvana and Post-stroke Rehab

NCT ID: NCT03095560

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-01-31

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.

Detailed Description

In this pilot study, we enrolled 20 post-stroke rehabilitation inpatients, who attended the Laboratory of Robotic and Cognitive Rehabilitation of IRCCS Neurolesi of Messina from June 2016 to January 2017. The inclusion criteria were: ischemic or hemorrhagic stroke in the chronic phase (i.e., at least 6 months from the acute neurological event); inability to stand independently for more than one minute; ability to sit for at least 20 minutes (including at least one minute without support); presence of moderate to mild cognitive impairment (Mini-Mental State Examination from 10 to 23); absence of disabling sensory alterations, severe psychiatric and other medical illness. The study was approved by the Local Ethical Committee. All the patients, adequately informed about the study, offered their collaboration, and provided informed consent to enter the study. 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. Both the groups underwent the same conventional physiotherapy program. 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 by a skilled neuropsychologist through the administration of a complete battery, and by a skilled neurologist to assess motor functions. All the patients were evaluated by a specific clinical-psychometric battery before (T0), and immediately (T1) after the end of the training. Primary outcomes consisted of the Montreal Cognitive Assessment Test (MoCA) and the Functional Independence Measure (FIM). In addition, we administered the Frontal Assessment Battery (FAB) to assess executive functions, Attentive Matrices (AM) and Trial Making Test (TMTA, TMTB, and TMTB-A) to measure the attention process, and the Trunk Control Test (TCT) and Motricity Index (MI) for upper limbs to evaluate motor functions.

BTsN TRAINING SETTING 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. At the end of each work session, it is possible to export the full list of all exercises performed and the score obtained for each of them. Concerning cognitive training, we included a series of exercises involving attention, memory (verbal and visuo-spatial), spatial cognition, ocular-manual coordination, gnosis abilities, problem solving, executive function, and constructive praxis.

Notably, in the BTsN device used in theS-IVT group the projector is located behind the patient, thus the shadow of the patient is projected on the screen, whereas in the S-IVTSgroup the projector is located in front of the patient and the shadow is not visible.

Conditions

Virtual Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

NIRVANA

Intervention Type: 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 without shadow (S-IVT)

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.

Group Type: EXPERIMENTAL

NIRVANA

Intervention Type: 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.

Interventions

NIRVANA

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.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Rocco Salvatore Calabrò

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28930852 (View on PubMed)

Other Identifiers

BSVR

Identifier Type: -

Identifier Source: org_study_id