Stroke
Conditions
Brief summary
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: * Does the SHAJA-based training improve walking velocity and endurance in post-stroke patients compared to conventional gait training? * Is the SHAJA exoskeleton safe and reliable? Researchers will compare the SHAJA-based training to a conventional gait training to see if the former works to improve walking ability. Participants will: * Perform six SHAJA-assisted gait training sessions or six conventional gait training sessions * Perform five assessment sessions
Interventions
DEVICEUnilateral hip exoskeleton
Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
BEHAVIORALConventional gait training
Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.
Sponsors
Scuola Superiore Sant'Anna di Pisa
Centro Riabilitativo Villa Beretta
Azienda Ospedaliero, Universitaria Pisana
Carmelo Chisari
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* cerebral stroke, at least 3 months from cerebral event * ability to ambulate with no more than minimal contact assistance, even with aids (Functional Ambulation Classification, FAC \>= 43) * self-selected walking velocity in the range \[0.3-0.85\] m/s * anthropometry consistent with the specifications of the tested devices * gait impairments that may benefit from hip assistance, e.g. hip weakness in flexion and/or extension (Medical Research Council, MRC, Scale for Muscle Strength \>2 and \<5 for flexion and extension)
Exclusion criteria
* Modified Ashworth Scale \>3 at the hip and/or ankle joints * Poor cognitive skills (corrected Mini-Mental State Examination, MMSE \< 21) * inability to follow verbal 3 step commands * severe aphasia causing inability to communicate with the investigators * serious medical conditions (recent myocardial infarction in less than 3 months, uncontrolled congestive heart failure (CHF), uncontrolled hypertension, uncontrolled seizures) * leg deep vein thrombosis less than 6 weeks ago * other pre-existing neurological disorders (Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Dementia) * severe anxiety or depression (State-Trait Anxiety Inventory-Y, STAI-Y \> 44, and the Beck Depression Inventory-II, BDI-II \> 19) * severe osteoporosis * severe hip / knee osteoarthritis with limitation of movement or significant pain * use of a colostomy bag * skin wounds, infection, or problems at device contact locations * major orthopaedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine) * cardiac surgery within the last 3 months * patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention * pregnancy * implanted cardiac devices, such as pacemakers or automatic defibrillators (AICD) * use of assistive device that, in the PI's opinion, could interfere with SHAJA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 |
| 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Modified Ashworth Scale (MAS) pre vs post Conventional training and SHAJA-assisted training interventions | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | The Modified Ashworth Scale ranges from 0 to 4, with lower scores indicating better outcome |
| 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 | 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 | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | The Berg Balance Scale ranges from 0 to 56, with higher scores indicating better performance |
| Changes in Motricity Index for Lower Limb pre vs post Conventional training and SHAJA-assisted training interventions | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | The Motricity Index ranges from 0 to 100, with higher scores indicating better performance |
| Changes in Functional Ambulation Classification (FAC) pre vs post Conventional training and SHAJA-assisted training interventions | From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1 | The Functional Ambulation Classification ranges from 1 to 6, with higher scores indicating better performance |
Other
| Measure | 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 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 |
| 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 lower-limb muscle synergies pre vs post Conventional training and SHAJA-assisted training interventions assessed by electromyography during walking | From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1 |
Countries
Italy
Outcome results
None listed