Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke (PoCH-Rehab)

Don Carlo Gnocchi Onlus Foundation

Status: Not yet enrolling

Conditions: Stroke Sequelae; Gait, Hemiplegic

Treatments: Device: Combined overground gait exoskeleton and FES applied to lower limb; Device: Overground gait exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT06436898

PoCH-Rehab

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Exoskeleton plus FES

Experimental group

Description:

Participants will train gait with an overground exoskeleton and a combined myoelectrically controlled Functional Electrostimulation System (FES) applied to lower limb muscles during execution of gait.

Treatment:

Device: Combined overground gait exoskeleton and FES applied to lower limb

Exoskeleton

Active Comparator group

Description:

Participants will train gait with an overground exoskeleton.

Treatment:

Device: Overground gait exoskeleton