Clinical trial NCT06436898: Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke
Official title: Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke (PoCH-Rehab)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Sequelae
Gait, Hemiplegic
Keywords: Gait rehabilitation
Exoskeleton
Functional Electrical Stimulation
Hemiplegia
Overground
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Istituto Italiano di Tecnologia
name: Istituto Nazionale di Ricovero e Cura per Anziani
First posted: 2024-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Capable of standing unsupported for at least one minute

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)
* Significant limitations in passive ROM of the hips and knees
* Problems with the integrity of the skin at the interface surfaces with the device or which would prevent sitting.
* Implanted electronic devices
* Epilepsy
* Severe peripheral neuropathies

Primary outcomes:
measure: System Usability scale (SUS)
timeFrame: At baseline and at post after 4 weeks of intervention
measure: Velocity of gait
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
Secondary outcomes:
measure: Motricity Index Lower limb (MI LL)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Fugl Meyer Assessment of motor recovery after stroke. Lower limb (FMA LL)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Functional Ambulation Category (FAC)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Stroke Rehabilitation Motivation Scale (7-item SRMS)
timeFrame: At baseline and at post after 4 weeks of intervention
measure: Fatigue Severity Scale (FSS)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Ashworth scale
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Manual muscle test (MMT)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Five times sit to stand test (5TStS)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Timed up and go test (TUG)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Two minutes walking test (2MWT)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: 10 meter walking test (10MVT)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: The walking handicap scale (WHS)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Unified Theory of Acceptance and Use of Technology (UTAUT)
timeFrame: At baseline and at post after 4 weeks of intervention
measure: Report of adverse events
timeFrame: at baseline and at post after 4 weeks of intervention
measure: Euro Quality of Life-5 -dimension Questionnaire (EQ-5D-5L)
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Motion parameters derived from the kinematics of the body
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Postural capabilities will be evaluated based on body kinetics
timeFrame: At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Muscular synergies
timeFrame: at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Instrumented 2 Minute Walk test (I2MWT)
timeFrame: at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
measure: Instrumented Timed Up and Go (ITUG)
timeFrame: at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Carlo Gnocchi IRCCS
Study officials:
affiliation: Research Head of Biomedical Technology Department
name: Maurizio Ferrarin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Head of the Neurological Unit
name: Andrea Corsonello, PhD
role: STUDY_DIRECTOR
References: