Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

NCT06436898 | Not Yet Recruiting

• 1 other identifier: PoCH-Rehab
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae; Gait, Hemiplegic

Keywords

Gait rehabilitation; Exoskeleton; Functional Electrical Stimulation; Hemiplegia; Overground

Outcome Measures

Primary Outcomes (2)

• System Usability scale (SUS)

  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.

  At baseline and at post after 4 weeks of intervention

• Velocity of gait

  Gait velocity during 3D gait analysis measured while walking overground over 10 meters. Velocity is measured in meters/second

  At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

Secondary Outcomes (21)

• 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

• 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

• Functional Ambulation Category (FAC)

  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

• Fatigue Severity Scale (FSS)

  At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

Study Arms (2)

Exoskeleton plus FES

EXPERIMENTAL

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.

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

Exoskeleton

ACTIVE COMPARATOR

Participants will train gait with an overground exoskeleton.

Device: Overground gait exoskeleton

Interventions

Combined overground gait exoskeleton and FES applied to lower limb DEVICE

Gait rehabilitation for persons with stroke, with an overground exoskeleton combined with an electromyographically controlled FES applied to lower limb muscles during gait.

Also known as: TWIN_Acta and FITFES

Exoskeleton plus FES

Overground gait exoskeleton DEVICE

Gait rehabilitation for persons with stroke, with an overground exoskeleton.

Also known as: TWIN_Acta

Exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤ FAC (Functional ambulation category) ≤ 3
• kg ≤ weight ≤ 90 kg
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituto Italiano di Tecnologia: collaborator
• Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi IRCCS

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Hemiplegia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Maurizio Ferrarin, PhD

  Research Head of Biomedical Technology Department

  PRINCIPAL INVESTIGATOR

• Andrea Corsonello, PhD

  Research Head of the Neurological Unit

  STUDY DIRECTOR

Central Study Contacts

Tiziana Lencioni, PhD

CONTACT

024030; tlencioni@dongnocchi.it

Johanna Jonsdottir, PhD

CONTACT

024030; jjonsdottir@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blind to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: May 31, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Preliminary data will be available at the end of the study February 2025
• Access Criteria: at request to the Principal investigator

Locations

IT (1)