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Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase).
Primary objectives: Evaluation of biomechanical and spatio-temporal asymmetries in gait in subjects with lower limb amputation by motion capture systems; improvement of postural stability and gait cycle in patients with lower limb amputation by "task-oriented" rehabilitation training and multisensory feedback generated by an immersive virtual reality environment, aiming at the enhancement of use-dependent brain plasticity; improving body weight distribution on both lower limbs, during static and dynamic activities, through more effective control of the body's centre of gravity. Secondary objectives include improving mood, psycho-social wellbeing and quality of life in lower limb amputees.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual environment practiced on the Caren | Experimental | Caren virtual training phase plus conventional physiotherapy phase |
|
| Conventional physiotherapy | Active Comparator | Conventional physiotherapy phase plus Caren virtual training phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual environment practiced on the Caren | Behavioral | The virtual environment practised on the Caren will make the scenario totally immersive and allow the subject to perform the motor task by recruiting muscles according to a motor coordination scheme different from the traditional one. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic data | From the gait analysis, the investigators will obtain kinematic data, including spatial and temporal parameters measured during standing acquisition and kinematic analysis evaluated from the walking trials recordings. | seven months |
| Kinetic data | From the gait analysis, the investigators will obtain kinetic data concerning the joint moments and powers, joints moments and powers normalized by the subject's weight (Newton*meter/kg e Watt/kg) and ground reaction forces reported in percentage to the body weight will be averaged across all cycles for each subject for each evaluating session. | seven months |
| Electromyography | From the gait analysis, the investigators will obtain electromyographic data on electromyopgraphic signals, regarding muscle contraction, which will be recorded with surface electrodes. The raw signals (millivolts) will be filtered with a band pass filter (20 - 450 Hz) and time-normalized for the duration of the gait cycle (% gait cycle). | seven months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirjam Bonanno, PT | Contact | +3909060128179 | mirjam.bonanno@irccsme.it | |
| Rocco Salvatore CalabrĂ², MD | Contact | +3909060128179 | roccos.calabro@irccsme.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Paladina, PT | IRCCS Centro Neurolesi Bonino Pulejo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro Neurolesi | Messina | Sicily | 98124 | Italy |
After the data collection we will report anonymised data on public repository
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Conventional physiotherapy | Behavioral | Conventional physiotherapy |
|