A Mobile Brain/Body Imaging Platform for the Assessment and Optimization of Post-stroke Overground Robotic Gait Treatments

Condition(s) studied

Investigational drug(s) / intervention(s)

overground wearable robotic device: To provide a complete overview of the complex system patient-technology, motor and cognitive evaluations, commonly used in daily clinical practice, will be performed at pre-treatment time (T0), after 12 sessions of treatment (T1) and one month follow-up time (T2). The first (E1) and the last session (E12) of treatment will be instrumented with EEG, EMG and GRF which will collect data.

Study summary

The study aims to identify neural biomarkers that can be used to monitor the recovery of locomotion and movement of post-stroke patients, both in natural settings and with enriched treatment using robotic device. These biomarkers could potentially be utilized in clinical practice to improve recovery outcomes. Additionally, the study seeks to investigate whether it is feasible to use these biomarkers to predict the extent of recovery that patients may achieve.

Eligibility

Primary outcome measure(s)

• Motor Outcome Measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Trunk Control Test (TCT) \[0-100\]
• Motor Outome Measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  6-minute walking Test (6mWT)
• Motor Outcome Measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  10 Meter Walk Test (10MWT)
• Motor Outcome Measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Berg Balance Scale (BBS) \[0-56\]
• Motor Outcome Measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Motricity Index (MI) at lower limb \[0-100\]
• Motor outcome measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  5 times Sit-to-Stand (5XSST)
• Motor Outcome Measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Modified Ashworth Scale (MAS) at lower limb
• Motor oucome measure — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Functional Ambulation Category (FAC) \[0-5\]
• Biomarkers — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Cortico-cortico coherence from EEG
• Biomarkes — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Cortico-muscular coherence EEG-EMG
• Biomarkers — From enrollment to the end of treatment at 4 weeks + 4 weeks follow-up
  Ground reaction forces during foot-ground interaction

Trial sites (1)

Other trials for the same condition