Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke (PoCH-Rehab)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke Sequelae
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- System Usability scale (SUS)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. Improving walking is therefore a primary rehabilitation goal for such patients. Robotic-Assisted Rehabilitation (RAR, e.g. exoskeletons) and Functional Electrical Stimulation (FES) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.
Detailed Description
Exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs. The investigators expect the same trend also for stroke. Based on prior exploratory activities using an overgorund exoskeleton (TWIN_Acta) in gait rehabilitation post stroke, in this project the aim is to merge the potential of an overground exoskeleton and FES to treat the lower limb motor deficits in persons post-stroke, strengthening their residual abilities. Synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization The persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with FES applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters. This experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •Diagnosis of first unilateral ischemic or hemorrhagic ictus, at least two weeks from the event, ischemic or hemorrhagic
- •diagnosis confermed with Computer Tomography or Magnetic Resonance Imaging
- •1 ≤ FAC (Functional ambulation category) ≤ 3
- •50 kg ≤ weight ≤ 90 kg
- •150 cm ≤ height ≤ 192 cm
- •Femor length: 355-475 mm
- •Tibia length: 405-485 mm
- •Pelvic width 690-990 mm
- •shoe size 36-45
Exclusion Criteria
- •Mini Mental State Examination score (corrected for age and education) \< 24
- •Clinical evidence in the medical records of visuospatial and ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders or those which prevent use of the device
- •patients at risk of fractures or with strategic fractures (unstabilized fractures or spinal instability)
- •Major head trauma
- •Subarachnoid hemorrhage, cerebral thrombosis
- •Cardio-respiratory or internal clinical instability
- •Pregnant or breastfeeding status;
- •Recent malignant neoplasm
- •Chronic inflammatory diseases with joint involvement of the lower limbs;
- •Severe spasticity (Ashworth\>3)
Outcomes
Primary Outcomes
System Usability scale (SUS)
Time Frame: At baseline and at post after 4 weeks of intervention
The SUS assesses Usability and Acceptability of a device. The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The scores will be normalized to produce a percentile ranking. The higher the percentage the better the tested device is considiered.
Velocity of gait
Time Frame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
Gait velocity during 3D gait analysis measured while walking overground over 10 meters. Velocity is measured in meters/second
Secondary Outcomes
- Functional Ambulation Category (FAC)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Motricity Index Lower limb (MI LL)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Fatigue Severity Scale (FSS)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Beck Depression Inventory-II (BDI-II)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Fugl Meyer Assessment of motor recovery after stroke. Lower limb (FMA LL)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Stroke Rehabilitation Motivation Scale (7-item SRMS)(At baseline and at post after 4 weeks of intervention)
- Manual muscle test (MMT)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Timed up and go test (TUG)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Ashworth scale(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Report of adverse events(at baseline and at post after 4 weeks of intervention)
- Two minutes walking test (2MWT)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- 10 meter walking test (10MVT)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Five times sit to stand test (5TStS)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- The walking handicap scale (WHS)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Unified Theory of Acceptance and Use of Technology (UTAUT)(At baseline and at post after 4 weeks of intervention)
- Euro Quality of Life-5 -dimension Questionnaire (EQ-5D-5L)(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Motion parameters derived from the kinematics of the body(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Postural capabilities will be evaluated based on body kinetics(At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Muscular synergies(at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Instrumented 2 Minute Walk test (I2MWT)(at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)
- Instrumented Timed Up and Go (ITUG)(at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention)