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| Name | Class |
|---|---|
| IRCCS Bonino Pulejo | UNKNOWN |
| Istituto S.Anna Crotone | UNKNOWN |
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The overall objective of the study is to compare upper limb cognitive and motor rehabilitation programs delivered via tele-rehabilitation and in-person, in order to evaluate their overall impact on the rehabilitation process of subjects with GCA outcomes at the end of the subacute phase.
The study is a controlled clinical trial aimed at evaluating the efficacy and feasibility of cognitive and motor rehabilitation programs delivered in person or via tele-rehabilitation. Sixty-two subjects, aged 18 to 75, of both sexes, will be consecutively enrolled at the three participating centers. The sample size was calculated assuming a change of 15 points (standard deviation 20) on the Brief Neuropsychological Examination (BNE), with alpha = 0.05, beta = 0.2, and a power of 80%. A 10% margin was added to the resulting number (28 subjects per group) for potential dropouts. The ENB was chosen as the primary measure because, validated in the Italian population, it allows for a comprehensive, multidomain assessment that is sensitive to changes in the main cognitive domains (attention, memory, language, executive and praxic functions), also allowing for the evaluation of treatment efficacy over time, with short administration times and good tolerability in patients with GCA outcomes. Recent multicenter studies have confirmed its reliability and clinical relevance in this population. Subjects will be assigned to two treatment groups using block randomization, stratified by age, gender, and baseline functional level. This procedure was adopted to reduce potential bias and ensure greater comparability between groups. However, a geographical restriction will be maintained: patients unable to physically access the facility will be included in the tele-rehabilitation group (TG), but will follow the same stratification and randomization procedure, ensuring methodological consistency and allowing for dedicated sensitivity analyses.
The in-person treatment group (GP) will complete 50-minute sessions, three times a week for eight weeks, at the rehabilitation center. The tele-rehabilitation treatment group (TG) will complete a similar program at home, with the same frequency and duration, via dedicated platforms.
Sixty-two subjects (18-75 years old, both genders) will be consecutively enrolled at the three participating centers upon discharge from hospital rehabilitation. Patients will be assigned equally to the two groups (in-person treatment and tele-rehabilitation) using block randomization stratified by age, gender, and functional level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Presence (GP) | Experimental | Patients in the in-person treatment group (GP) will undergo 50-minute sessions, three times a week, for a total of eight weeks using VRRS virtual reality systems (Khymeia, Padua, Italy), certified Class A medical devices. |
|
| Group Tele-Rehabilitation | Active Comparator | The telerehabilitation treatment group (GT) will receive a similar motor and cognitive treatment program at home using the VRRS HomeKit device (Khymeia, Padua, Italy), another certified Class 1 medical device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-rehabilitation | Device | The telerehabilitation treatment group (GT) will receive a similar motor and cognitive treatment program at home using the VRRS HomeKit device (Khymeia, Padua, Italy), another certified Class 1 medical device. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Neuropshychological Examination | Pre-intervetion and immediately after 8 weeks of intervention | |
| Flug Meyer Upper Extremity Scale | Pre-intervetion and immediately after 8 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale | Pre-intervetion and immediately after 8 weeks of intervention | |
| Client Satisfaction Questionnaire-8 Total scores range from 8 to 32, with the higher number indicating greater satisfaction | Pre-intervetion and immediately after 8 weeks of intervention |
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Inclusion Criteria:
Outcome of Severe Acquired Brain Injury (GAI) of various etiologies;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Posteraro | Contact | +3905746057061 | federico.posteraro@uslnordovest.toscana.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40342223 | Background | Maggio MG, Rizzo A, De Francesco M, Barbera M, Kamran M, De Luca R, Corallo F, Quartarone A, Calabro RS. What About the Differences in Body Representation and Body Image Between Stroke Patients and Healthy Controls? Psychological and Clinical Implications. Brain Behav. 2025 May;15(5):e70155. doi: 10.1002/brb3.70155. | |
| 40652006 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Group Presence | Device | Patients in the in-person treatment group (GP) will undergo 50-minute sessions, three times a week, for a total of eight weeks using VRRS virtual reality systems (Khymeia, Padua, Italy), certified Class 1 medical devices. The first four weeks of treatment will be conducted with VRRS EVO, while the following four weeks will be conducted with VRRS Physio, with exercises designed to improve various cognitive and motor domains of the upper limb. |
|
| Maggio MG, Bonanno L, Rizzo A, Barbera M, Benenati A, Impellizzeri F, Corallo F, De Luca R, Quartarone A, Calabro RS. The role of virtual reality-based cognitive training in enhancing motivation and cognitive functions in individuals with chronic stroke. Sci Rep. 2025 Jul 12;15(1):25258. doi: 10.1038/s41598-025-08173-1. |
| 38790389 | Background | De Luca R, Calderone A, Gangemi A, Rifici C, Bonanno M, Maggio MG, Cappadona I, Veneziani I, Ielo A, Corallo F, Quartarone A, Cardile D, Calabro RS. Is Virtual Reality Orientation Therapy Useful to Optimize Cognitive and Behavioral Functioning Following Severe Acquired Brain Injury? An Exploratory Study. Brain Sci. 2024 Apr 23;14(5):410. doi: 10.3390/brainsci14050410. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |