StrokeSHAJA-RNCT07035730
Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton
A study testing Unilateral hip exoskeleton and Conventional gait training in people with Stroke, run by Carmelo Chisari at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Unilateral hip exoskeleton and Conventional gait training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
Centro Riabilitativo Villa Beretta
Costa Masnaga, Italy, 23845
Giovanna Palumbo, +390318544215, gpalumbo2001it@yahoo.it
Franco Molteni
- Recruiting
SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Stefania Dalise, +39050994282, stefania.dalise@ao-pisa.toscana.it
Stefania Dalise
About this study
Official title: Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
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
- Conditions
- Stroke
- Being tested
- Unilateral hip exoskeleton, Conventional gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral hip exoskeletonDevice
Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.
Conventional gait trainingBehavioural
Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Unilateral hip exoskeleton; Behavioral: Conventional gait training |
| 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 Receives: Device: Unilateral hip exoskeleton; Behavioral: Conventional gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device-related adverse events
Measured: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Documenting device hardware and software malfunctions
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Secondary outcomes (6)
Changes in gait kinematics/kinetics pre vs post Conventional training and SHAJA-assisted training interventions assessed with a motion capture system
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start7 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmelo Chisari
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Villa Beretta Rehabilitation Center, Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Sponsor-investigator, Carmelo Chisari, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035730
- Sponsor's protocol ID
- 0003812/2025
- Acronym
- SHAJA-R
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
- ClinicalTrials.gov ID
- NCT07035730
- Acronym / sponsor ID
- SHAJA-R / 0003812/2025
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Carmelo ChisariUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Villa Beretta Rehabilitation Center, Azienda Ospedaliero, Universitaria Pisana
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHAJA first, then conventional | Experimental | Device: Unilateral hip exoskeleton, Behavioral: Conventional gait trainingPatients 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 | Device: Unilateral hip exoskeleton, Behavioral: Conventional gait trainingPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral hip exoskeletonUnilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes. | Device | Conventional first, then SHAJA, SHAJA first, then conventional |
| Conventional gait trainingConventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes. | Behavioural | Conventional first, then SHAJA, SHAJA first, then conventional |
Primary outcome
Number of device-related adverse events
Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Documenting device hardware and software malfunctions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
6 secondary outcomes
Changes in gait kinematics/kinetics pre vs post Conventional training and SHAJA-assisted training interventions assessed with a motion capture system
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral hip exoskeleton and Conventional gait training in people with Stroke, run by Carmelo Chisari at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of device-related adverse events (time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.