Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07510633

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Follow-up

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

Loading map...

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

Similar Trials

Efficacy and Target Engagement of a Digital Intervention to ...

Executive Dysfunction

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here