Actively Recruiting
A Mobile Brain/Body Imaging Platform for the Assessment and Optimization of Post-stroke Overground Robotic Gait Treatments
Led by Dr. Franco Molteni · Updated on 2026-04-03
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating neural biomarkers that may help track and predict recovery of movement and walking ability in patients after a stroke. This study focuses on both natural walking and enhanced therapy using a robotic device. Understanding these biomarkers could improve personalized rehabilitation and recovery outcomes for stroke survivors who often face long-term motor impairments like difficulty walking and balance problems. The study involves training stroke patients with an overground wearable robotic device across 12 treatment sessions. Evaluations occur before treatment, after the 12 sessions, and one month later. During the first and last sessions, brain and muscle activity, as well as ground reaction forces, are recorded using EEG, EMG, and force sensors to monitor progress and interaction with the robotic device. Participants will undergo motor and cognitive assessments commonly used in clinical practice at multiple time points. Researchers will measure motor outcomes from enrollment through the end of treatment at 4 weeks and at a 4-week follow-up. The study aims to gather detailed data on brain-muscle connectivity and mobility improvements to better understand and optimize robotic gait rehabilitation after stroke.
CONDITIONS
Brief Title
A Mobile Brain/Body Imaging Platform for the Assessment and Optimization of Post-stroke Overground Robotic Gait Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stroke patients with ischemic or hemorrhagic causes
- Able to walk independently, with or without aids/orthosis (FAC > 2)
- Able to provide informed consent and understand study instructions
- Body size adequate to wear the exoskeleton device
- Body weight less than 90 kg
- Height between 150 and 192 cm
- Thigh length between 355 and 475 mm
- Calf length between 405 and 485 mm
- Hip width between 690 and 990 mm
You will not qualify if you...
- Unable to provide informed consent or understand study tasks
- Fixed contracture in lower limbs preventing use of the exoskeleton
- Unable to walk independently (FAC ≤ 2)
- Body size not suitable for the exoskeleton device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants train with an overground wearable robotic device during 12 treatment sessions to improve gait and motor function after stroke.
12 treatment sessions with instrumented first and last sessions
Duration - 4 weeks
Participants are monitored for an additional 4 weeks after the end of treatment to evaluate sustained motor outcomes and biomarkers.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Villa Beretta Rehabilitation Center
Costa Masnaga, Lecco, Italy, 23845
Actively Recruiting
Research Team
F
Franco Molteni, MD
E
Eleonora Guanziroli, Eng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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