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Search / Trial NCT05579197

Myosuit Chronic Stroke Protocol

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Oct 11, 2022

Trial Information

Current as of June 17, 2025

Completed

Keywords

Stroke Robotics Exosuit Lower Limbs Rehabilitation Assistance Usability

ClinConnect Summary

A stroke, either ischemic or haemorrhagic, is a vascular condition that can suddenly cause the loss of neurological functions \[1\]. The disability derived from a stroke can imply reduced communication and limited activities of daily living in the long term. Specifically, reduced mobility and equilibrium, walking asymmetry and spasticity of the impaired limb are the principal factors related to long-term limited physical activity and moderate dependency of the patient on the caregiver \[2,3\]. A walking deficit can have severe consequences on the energetic cost and the risk of falling, as w...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Clinical stability, evaluated through the administration of the MEWS scale (Modified Early Warning Score);
  • To be able to stand up from a chair without exceeding a trunk angle of 45° to the left or right during the movement;
  • To be able to walk for 10 m without the support of another person but, if necessary, with conventional aids different than knee othesis (e.g. stick, crutch, ankle/foot orthesis). The aid considered should have single-support;
  • Height between 150 cm and 195 cm;
  • Weight between 45 kg and 110 kg;
  • FAC (Functional Ambulation Calssification) ≥3;
  • MAS (Modified Ashworth Scale) ≤2;
  • HADS (Hospital Anxiety and Depression Scale) with normative values (\>10/21 for each scale);
  • MoCA (Montreal Cognitive Assessment) (Equivalent scoring \> 1 with the Italian correction from Santangelo et al._ 2015);
  • To be able to understand and sign the informed consent.
  • Exclusion Criteria:
  • Presence of an active (or with effects) neurological or psychiatric pathology occurred before the vascular event;
  • Severe bilateral hearing or sight loss;
  • Functional Reach Test \<15.24;
  • Flexion retruction of hip and knee greater than 10° and not reducible;
  • Presence of genu varum or geru valgum greater than 10°;
  • Pregnancy;
  • Previous stroke.

About Fondazione Don Carlo Gnocchi Onlus

Fondazione Don Carlo Gnocchi Onlus is a distinguished non-profit organization dedicated to advancing healthcare and rehabilitation services for individuals with disabilities and chronic illnesses. Established in honor of the legacy of Don Carlo Gnocchi, the foundation focuses on integrating scientific research with clinical practice, striving to enhance the quality of life for patients through innovative therapies and comprehensive care programs. With a commitment to excellence, the foundation actively engages in clinical trials and research initiatives aimed at improving treatment outcomes and fostering a deeper understanding of rehabilitation methodologies. Its collaborative approach brings together healthcare professionals, researchers, and community stakeholders to promote well-being and support patient-centric solutions.

Locations

Firenze, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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