Actively Recruiting
Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton
Led by Carmelo Chisari · Updated on 2025-08-19
20
Participants Needed
2
Research Sites
77 weeks
Total Duration
On this page
Sponsors
C
Carmelo Chisari
Lead Sponsor
S
Scuola Superiore Sant'Anna di Pisa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cerebral stroke at least 3 months before the study
- Ability to walk with no more than minimal contact assistance, even with aids (Functional Ambulation Classification ≥ 43)
- Self-selected walking speed between 0.3 and 0.85 meters per second
- Body measurements compatible with the device specifications
- Hip muscle strength for flexion and/or extension between 3 and 4 on the Medical Research Council Scale
You will not qualify if you...
- Modified Ashworth Scale greater than 3 at hip or ankle joints
- Poor cognitive function (Mini-Mental State Examination score below 21)
- Unable to follow three-step verbal commands
- Severe aphasia affecting communication
- Serious medical conditions like recent heart attack (within 3 months), uncontrolled heart failure, hypertension, or seizures
- Recent leg deep vein thrombosis (within 6 weeks)
- Other neurological disorders such as Parkinson's disease, ALS, Multiple Sclerosis, or Dementia
- Severe anxiety or depression
- Severe osteoporosis
- Severe hip or knee osteoarthritis with limited movement or significant pain
- Use of a colostomy bag
- Skin wounds or infections at device contact areas
- Major orthopedic surgery or fractures in the last 90 days
- Cardiac surgery within the last 3 months
- Current or recent participation in other research affecting study responses
- Pregnancy
- Implanted cardiac devices like pacemakers or defibrillators
- Use of assistive devices interfering with the SHAJA device
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centro Riabilitativo Villa Beretta
Costa Masnaga, Italy, Italy, 23845
Not Yet Recruiting
2
SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy, 56124
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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