Mobile brain‑body imaging to optimize overground robotic gait therapy after stroke
A Mobile Brain/Body Imaging Platform for the Assessment and Optimization of Post-stroke Overground Robotic Gait Treatments
NA · Villa Beretta Rehabilitation Center · NCT07510633
This project will test whether brain and muscle signals recorded during walking, both naturally and while using an overground wearable robot, can monitor and predict gait recovery in people after stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Villa Beretta Rehabilitation Center (other) |
| Locations | 1 site (Costa Masnaga, Lecco) |
| Trial ID | NCT07510633 on ClinicalTrials.gov |
What this trial studies
The study records EEG, EMG, and ground-reaction measures while people with stroke walk in natural settings and while using an overground wearable exoskeleton. Researchers will analyze these brain and muscle signals to identify neural biomarkers linked to locomotor control and to changes during robotic-assisted training. Participants will be selected based on walking ability and body measurements required to safely wear the device, and sessions will include overground gait with and without the robotic device. The goal is to see whether these biomarkers track recovery and can predict how much walking function a participant may regain.
Who should consider this trial
Good fit: Adults (≥18 years) who had an ischemic or hemorrhagic stroke, can walk independently with or without aids (FAC>2), and whose body size and weight meet the exoskeleton limits (weight <90 kg; height 150–192 cm; specified thigh, calf, and hip measurements).
Not a fit: Patients who cannot walk independently (FAC≤2), have fixed lower-limb contractures, cannot provide informed consent or follow instructions, or whose anthropometrics fall outside the device limits are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, clinicians could use the identified biomarkers to tailor robotic gait therapy and better predict individual recovery after stroke.
How similar studies have performed: Previous pilot studies combining EEG/EMG recordings with robotic gait devices have shown promising signals and feasibility, but large-scale clinical proof of improved outcomes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old * Stroke patients with different etiology: ischemic or hemorrhagic * Able to walk independently, eventually with aids/orthosis (FAC\>2) * Able to give the informed consent and to comprehend the instructions necessary to complete the task * Subject's anthropometric parameters adequate to wear the exoskeleton; * Body weight \< 90 kg; * Height 150 ÷ 192 cm; * Thigh lenght: 355 ÷ 475 mm; * Calf lenght: 405 ÷ 485 mm; * Hip width : 690 ÷ 990 mm; Exclusion Criteria: * Incapacity to give the informed consent and understand the tasks required * Fixed contracture at lower limbs that limits the use of the exoskeleton * Incapacity to walk independently (FAC\<=2) * Subject's anthropometric parameters not adequate to wear the exoskeleton
Where this trial is running
Costa Masnaga, Lecco
- Villa Beretta Rehabilitation Center — Costa Masnaga, Lecco, Italy (RECRUITING)
Study contacts
- Principal investigator: Franco Molteni, MD — Villa Beretta Rehabilitation Center
- Study coordinator: Franco Molteni, MD
- Email: fmolteni@valduce.it
- Phone: +39 031 8544219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Overground wearable robotic device, EEG, EMG, Ground Reaction