Myosuit Chronic Stroke Protocol

NCT05579197 | Completed

• 1 other identifier: MyoSCSP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A stroke is a vascular condition that can suddenly cause the loss of neurological functions. The disability derived from a stroke can imply reduced communication and limited activities of daily living in the long term. Thus, specifically walking rehabilitation is crucial in order to restore the lower limbs' function and to re-establish the social participation of patients. Robotics has been demonstrated in being a suitable and effective tool in order to assist and treat post-stroke patients, thanks to its capability to deliver intensive and task-oriented training. Specifically, the exosuits, are a sub-group of robotics devices designed in lighter materials that assist the patients by actively moving the hip, knee or ankle. Given this framework, the aim of this work is to conduct a pilot study on the usability and perceived effectiveness of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The secondary aims of the study concern the evaluation of the functional performances of the patients both with and without the device and before and after the treatment.

Conditions

Stroke; Ischemic Stroke; Haemorrhagic Stroke

Keywords

stroke; robotics; exosuit; lower-limbs; rehabilitation; assistance; usability

Outcome Measures

Primary Outcomes (2)

• Usability of the device

  System Usability Scale (SUS) Range: 0-100, with 100 corresponding to the highest degree of usability

  Evaluated at session 10 (after the treatment) at an average of 3 weeks

• Self-efficacy

  Stroke Self-Efficacy Questionnaire (SSEQ-10) Range: 0-39; with 39 corresponding to the maximum confidence of the patient in self-efficacy

  Evaluated at session 10 (after the treatment), at an average of 3 weeks

Secondary Outcomes (10)

• Variation of functional status after the treatment

  Evaluated at session 1 (before the beginning of the treatment) and at session 10 (after the treatment) without the device

• Functional assistive direct effect of the device

  Evaluated at session 1 (before the beginning of the treatment) with and without the device

• Variation of walking capabilities after the treatment

  Evaluated at session 1 (before the beginning of the treatment) and at session 10 (after the treatment) without the device

• Assistive direct effect of the device on walking capabilities

  Evaluated at session 1 (before the beginning of the treatment) with and without the device

• Variation of walking capabilities after the treatment

  Evaluated at session 1 (before the beginning of the treatment) and at session 10 (after the treatment) without the device

Study Arms (1)

Lower limbs robotic intervention

EXPERIMENTAL

The intervention administered in this arm is a lower limb robotic intervention using the device Myosuit. The intervention includes: * An enrollment (session1), in which a clinical and psychological evaluation is performed for the assessment of the inclusion criteria * A baseline evaluation (session2), in which a functional evaluation is performed both with and without the device * Training sessions (sessions 3-9), these are the actual training sessions in which walking, sit to stand, balance and stairs climbing tasks are performed with the device on * Final evaluation (session 10), in which a final functional, clinical, and psychological assessment is performed The sessions are performed 3 times per week, with a duration of 45 minutes, with the expection of the assessement ones, session 1, 2 and 10, that have a duration of 1h, 2h and 3h, respectively.

Device: Lower-limb robotic intervention

Interventions

Lower-limb robotic intervention DEVICE

The intervention proposed in this study involves the use of an exosuit for lower limbs, the Myosuit. The selection of the tasks has been done in order to replicate typical activities of daily living in a structured environment, i.e. a rehabilitation hospital. Specifically, the tasks involve walking, sit to stand, balance and stair climbing. During the phases of assessment (session 2 and session 10), other devices are be used. Specifically: * The Optogait system; for a markerless gait analysis; * The Gyko sensor; an inertial sensor that will be used at the beginning of the training for the synchronisation of the signals recorded by the Myosuit and the signal recorded by the Optogait. Finally, during all the sessions, the Polar heart rate sensor is used to constantly monitor the cardiac frequency of the patients.

Lower limbs robotic intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• MyoSwiss AG: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi onlus

Florence, 50143, Italy

Location

Related Publications (10)

• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

  PMID: 34487721 BACKGROUND

• Ammann BC, Knols RH, Baschung P, de Bie RA, de Bruin ED. Application of principles of exercise training in sub-acute and chronic stroke survivors: a systematic review. BMC Neurol. 2014 Aug 22;14:167. doi: 10.1186/s12883-014-0167-2.

  PMID: 25162455 BACKGROUND

• Farrell JW 3rd, Merkas J, Pilutti LA. The Effect of Exercise Training on Gait, Balance, and Physical Fitness Asymmetries in Persons With Chronic Neurological Conditions: A Systematic Review of Randomized Controlled Trials. Front Physiol. 2020 Nov 12;11:585765. doi: 10.3389/fphys.2020.585765. eCollection 2020.

  PMID: 33281619 BACKGROUND

• Opara JA, Jaracz K. Quality of life of post-stroke patients and their caregivers. J Med Life. 2010 Jul-Sep;3(3):216-20.

  PMID: 20945810 BACKGROUND

• Brands IM, Wade DT, Stapert SZ, van Heugten CM. The adaptation process following acute onset disability: an interactive two-dimensional approach applied to acquired brain injury. Clin Rehabil. 2012 Sep;26(9):840-52. doi: 10.1177/0269215511432018. Epub 2012 Jan 19.

  PMID: 22261814 BACKGROUND

• French B, Thomas LH, Leathley MJ, Sutton CJ, McAdam J, Forster A, Langhorne P, Price CI, Walker A, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006073. doi: 10.1002/14651858.CD006073.pub2.

  PMID: 17943883 BACKGROUND

• Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.

  PMID: 28488268 BACKGROUND

• Lee HJ, Lee SH, Seo K, Lee M, Chang WH, Choi BO, Ryu GH, Kim YH. Training for Walking Efficiency With a Wearable Hip-Assist Robot in Patients With Stroke: A Pilot Randomized Controlled Trial. Stroke. 2019 Dec;50(12):3545-3552. doi: 10.1161/STROKEAHA.119.025950. Epub 2019 Oct 18.

  PMID: 31623545 BACKGROUND

• Schmidt K, Duarte JE, Grimmer M, Sancho-Puchades A, Wei H, Easthope CS, Riener R. The Myosuit: Bi-articular Anti-gravity Exosuit That Reduces Hip Extensor Activity in Sitting Transfers. Front Neurorobot. 2017 Oct 27;11:57. doi: 10.3389/fnbot.2017.00057. eCollection 2017.

  PMID: 29163120 BACKGROUND

• Haufe FL, Schmidt K, Duarte JE, Wolf P, Riener R, Xiloyannis M. Activity-based training with the Myosuit: a safety and feasibility study across diverse gait disorders. J Neuroeng Rehabil. 2020 Oct 8;17(1):135. doi: 10.1186/s12984-020-00765-4.

  PMID: 33032627 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Helping Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: October 13, 2022
• Study Start: April 7, 2022
• Primary Completion: April 7, 2023
• Study Completion: October 10, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

IT (1)