Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

NCT07035730 | Recruiting

• 1 other identifier: 0003812/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (6)

• 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

• 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

• 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

Other Outcomes (4)

• 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

  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

Study Arms (2)

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

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

Device: Unilateral hip exoskeleton; Behavioral: Conventional gait training

Interventions

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.

Conventional first, then SHAJA; SHAJA first, then conventional

Conventional gait training BEHAVIORAL

Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Conventional first, then SHAJA; SHAJA first, then conventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmelo Chisari: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator
• Centro Riabilitativo Villa Beretta: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (2)

Centro Riabilitativo Villa Beretta

Costa Masnaga, Italy, 23845, Italy

NOT YET RECRUITING

SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 25, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (2)