Valutazione Degli Effetti di un Dispositivo Indossabile Per Arto Inferiore (Myosuit) Sulla accettabilità e Parametri Funzionali di Pazienti Cronici Post-ictus: Studio Pilota.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Self-efficacy
Study Overview
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.
Detailed Description
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 well as on the participation and personal identity of the person [4].
Moreover, another psychological area that can be affected is self-efficacy, defined as the individual capabilities to take actions for obtaining results. Hence, for a person affected by stroke, self-efficacy is crucial and connected to his/her adaptation to the new condition [5].
For these reasons, walking rehabilitation is essential to recover lower limbs' function, restore self-efficacy and re-establish the social participation of patients [6].
Robotics has been demonstrated in being a suitable and effective tool in order to assist and treat post-stroke patients [7], thanks to its capability to deliver intensive and task-oriented training. One of the most common modalities to classify robotics devices is according to their structure, and the modality to interface with the patients. In these regards, we can distinguish between exoskeletons and end-effector robots, given their characteristics to wear the patient and guide him/her through the distal handle of the mechanical chain, respectively. Moreover, among the exoskeletons, the exosuits are a sub-group of robotics devices designed in lighter materials and that assist the patients by actively moving the hip, knee or ankle.
The lightweight of exosuits makes them suitable both for ecological and therapy-related settings, as well as assistance applications. It is also worth noticing that the absence of a rigid structure requires the patients to have an active component in the walking activity. Previous studies highlighted how these devices can have a supportive capacity during the propulsion phases of gait, assisting the patients throughout the walk [8].
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lower limbs robotic intervention
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.
Intervention: Lower-limb robotic intervention (Device)
Outcomes
Primary Outcomes
Self-efficacy
Time Frame: Evaluated at session 10 (after the treatment), at an average of 3 weeks
Stroke Self-Efficacy Questionnaire (SSEQ-10) Range: 0-39; with 39 corresponding to the maximum confidence of the patient in self-efficacy
Usability of the device
Time Frame: Evaluated at session 10 (after the treatment) at an average of 3 weeks
System Usability Scale (SUS) Range: 0-100, with 100 corresponding to the highest degree of usability
Secondary Outcomes
- 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 stair ascending and descending 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 stair ascending and descending capabilities(Evaluated at session 1 (before the beginning of the treatment) with and without the device)
- Variation of gait kinematic 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 gait kinematic(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)