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| Name | Class |
|---|---|
| Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna | OTHER |
| Villa Beretta Rehabilitation Center | OTHER |
| Azienda Ospedaliero, Universitaria Pisana | OTHER |
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The goal of this clinical trial is to evaluate the safety, reliability, and short-term effectiveness of SHAJA-based training in improving walking velocity and endurance in post-stroke patients.
The main questions it aims to answer are:
Researchers will compare the SHAJA-based training to a conventional gait training to see if the former works to improve walking ability.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHAJA first, then conventional | Experimental | Patients will perform the SHAJA-assisted gait training during the first period of the trial followed by a conventional gait training during the second period of the trial |
|
| Conventional first, then SHAJA | Experimental | Patients will perform the conventional gait training during the first period of the trial followed by a SHAJA-assisted gait training during the second period of the trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral hip exoskeleton | Device | Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of device-related adverse events | From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 | |
| Documenting device hardware and software malfunctions | From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 | |
| Changes in self-selected walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | |
| Changes in fast walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | |
| Changes in the difference between self-selected and fast walking velocity (delta m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | |
| Changes in walking endurance (in minutes) pre vs post Conventional training and SHAJA-assisted training interventions assessed with a Walk Test | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gait kinematics/kinetics pre vs post Conventional training and SHAJA-assisted training interventions assessed with a motion capture system | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | |
| Changes in the execution time of the Timed-Up-and-Go (TUG) test pre vs post Conventional training and SHAJA-assisted training interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lower-limb muscle activity through superficial Electromyography (sEMG) pre vs post Conventional training and SHAJA-assisted training interventions | From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 | |
| Changes in lower-limb muscle synergies pre vs post Conventional training and SHAJA-assisted training interventions assessed by electromyography during walking |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Riabilitativo Villa Beretta | Not yet recruiting | Costa Masnaga | Italy | 23845 | Italy |
all IPD that underlie results in a publication
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional gait training | Behavioral | Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes. |
|
| From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 |
| Changes in Berg Balance Scale pre vs post Conventional training and SHAJA-assisted training interventions | The Berg Balance Scale ranges from 0 to 56, with higher scores indicating better performance | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 |
| Changes in Motricity Index for Lower Limb pre vs post Conventional training and SHAJA-assisted training interventions | The Motricity Index ranges from 0 to 100, with higher scores indicating better performance | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 |
| Changes in Modified Ashworth Scale (MAS) pre vs post Conventional training and SHAJA-assisted training interventions | The Modified Ashworth Scale ranges from 0 to 4, with lower scores indicating better outcome | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 |
| Changes in Functional Ambulation Classification (FAC) pre vs post Conventional training and SHAJA-assisted training interventions | The Functional Ambulation Classification ranges from 1 to 6, with higher scores indicating better performance | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 |
| From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 |
| Changes in cortico-cortical connectivity through superficial Electroencephalography (sEEG) pre vs post Conventional training and SHAJA-assisted training interventions | From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 |
| Changes in cortico-muscular connectivity through sEMG and sEEG pre vs post Conventional training and SHAJA-assisted training interventions | From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 |
| SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | Italy | 56124 | Italy |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |