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NCT07035730Recruiting

Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
3 Jun 2025
Start date
Jul 2025
Primary completion date
Dec 2026
Lead sponsor
Carmelo Chisari
Diseases
Stroke
NCT number
NCT07035730

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From Jul 2025 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • major orthopaedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine)

Other illness

  • 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)
  • skin wounds, infection, or problems at device contact locations
  • cardiac surgery within the last 3 months
  • implanted cardiac devices, such as pacemakers or automatic defibrillators (AICD)

Other

  • 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
  • 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
  • patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention
  • pregnancy
  • use of assistive device that, in the PI's opinion, could interfere with SHAJA

Who the study is looking for

  • 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)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Riabilitativo Villa Beretta
Coordinator of this site? Confirm its status
Costa MasnagaItalyNot yet recruiting
SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.