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NCT Number: NCT07035730

Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Riabilitativo Villa Beretta, Costa Masnaga, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 gait training

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

    The Berg Balance Scale ranges from 0 to 56, with higher scores indicating better performance

  4. 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

    The Motricity Index ranges from 0 to 100, with higher scores indicating better performance

  5. 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

    The Modified Ashworth Scale ranges from 0 to 4, with lower scores indicating better outcome

  6. 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

    The Functional Ambulation Classification ranges from 1 to 6, with higher scores indicating better performance

Other outcomes

  1. Changes in lower-limb muscle activity through superficial Electromyography (sEMG) pre vs post Conventional training and SHAJA-assisted training interventions

    Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1

  2. Changes in lower-limb muscle synergies pre vs post Conventional training and SHAJA-assisted training interventions assessed by electromyography during walking

    Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1

  3. Changes in cortico-cortical connectivity through superficial Electroencephalography (sEEG) pre vs post Conventional training and SHAJA-assisted training interventions

    Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1

  4. Changes in cortico-muscular connectivity through sEMG and sEEG pre vs post Conventional training and SHAJA-assisted training interventions

    Time frame: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1

Sponsors and collaborators

Lead sponsor

Carmelo Chisari

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Pisana
  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
  • Villa Beretta Rehabilitation Center

Registry information

Official study title

Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes

Acronym: SHAJA-R

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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