StrokeMyoSCSPNCT05579197
Myosuit Chronic Stroke Protocol
A study testing Lower-limb robotic intervention in people with Stroke and Ischemic Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Haemorrhagic Stroke
- What is being tested?
- Lower-limb robotic intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2022to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valutazione Degli Effetti di un Dispositivo Indossabile Per Arto Inferiore (Myosuit) Sulla accettabilità e Parametri Funzionali di Pazienti Cronici Post-ictus: Studio Pilota.
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.
Read more
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.
Read the 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].
The Myosuit device is a wearable exosuit capable to provide assistance during the walk, sit to stand transition and stair climb [9]. Its assistance is provided with an exo-tendon mechanism. More in detail, online analysis of inertial signals allows to segment the gait phases and to assist at the extension of the knee and hip [9].
Many previous studies show promising results in the deambulation of spinal cord injuries or patients with lower-limb disorders [9,10]. These results were evaluated both in terms of kinematics and the safety of the patients. However, the studies conducted to highlight the urgency for the validation of the device in bigger and different cohorts [9,10].
Given this framework, the aim of this work is to conduct a pilot study on the effects of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The effects of the device will be analysed in terms of usability of the device, self-efficacy, and functional parameters of gait.
- Conditions
- Stroke, Ischemic Stroke, Haemorrhagic Stroke
- Being tested
- Lower-limb robotic intervention
- Keywords
- stroke, robotics, exosuit, lower-limbs, rehabilitation, assistance, usability
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-limb robotic interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lower-limb robotic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the device
System Usability Scale (SUS) Range: 0-100, with 100 corresponding to the highest degree of usability
Measured: 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
Measured: Evaluated at session 10 (after the treatment), at an average of 3 weeks
Secondary outcomes (10)
Variation of functional status after the treatment
Short Physical Performance Battery (SPPB) Range: 0-12; with 12 corresponding to the best perfromance on balance, walking, and sit-to-stand tasks
Measured: 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
Short Physical Performance Battery (SPPB) Range: 0-12; with 12 corresponding to the best perfromance on balance, walking, and sit-to-stand tasks
Measured: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Variation of walking capabilities after the treatment
Distance walked during the Two Minutes Walking Test (2minWT), in meters
Range: Not available; higher distances represent better performances on the walking task
Measured: 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
Distance walked during the Two Minutes Walking Test (2minWT), in meters
Range: Not available; higher distances represent better performances on the walking task
Measured: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Variation of walking capabilities after the treatment
Time needed to execute the 10 Meters Walk Test (10mWT), in seconds
Range: Not available; higher durations represent worst performances on the walking task
Measured: 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
Time needed to execute the 10 Meters Walk Test (10mWT), in seconds
Range: Not available; higher durations represent worst performances on the walking task
Measured: 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
Time needed to execute the Stair Climb Test (SCT), in seconds
Range: Not available; higher durations represent worst performances on the stair climb task
Measured: 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
Time needed to execute the Stair Climb Test (SCT), in seconds
Range: Not available; higher durations represent worst performances on the stair climb task
Measured: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Variation of gait kinematic after the treatment
Spatio-temporal kinematic parameters extracted from the Optogait system, such as:
- step length (meters)
- stride length (meters)
- stride time (seconds)
- step time (seconds)
- swing time (seconds)
- cadence (steps/minute)
- velocity (meters/seconds)
Measured: 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
Spatio-temporal kinematic parameters extracted from the Optogait system, such as:
- step length (meters)
- stride length (meters)
- stride time (seconds)
- step time (seconds)
- swing time (seconds)
- cadence (steps/minute)
- velocity (meters/seconds)
Measured: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start7 Apr 2022
- Primary completion7 Apr 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- MyoSwiss AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579197
- Sponsor's protocol ID
- MyoSCSP
- Acronym
- MyoSCSP
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34487721Ammann 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.
PubMed 25162455Farrell 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.
PubMed 33281619Opara JA, Jaracz K. Quality of life of post-stroke patients and their caregivers. J Med Life. 2010 Jul-Sep;3(3):216-20.
PubMed 20945810Brands 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.
PubMed 22261814French 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.
PubMed 17943883Mehrholz 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.
PubMed 28488268Lee 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.
PubMed 31623545Schmidt 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.
PubMed 29163120Haufe 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.
PubMed 33032627
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Degli Effetti di un Dispositivo Indossabile Per Arto Inferiore (Myosuit) Sulla accettabilità e Parametri Funzionali di Pazienti Cronici Post-ictus: Studio Pilota.
- ClinicalTrials.gov ID
- NCT05579197
- Acronym / sponsor ID
- MyoSCSP / MyoSCSP
- Conditions
- Stroke, Ischemic Stroke, Haemorrhagic Stroke
- Keywords
- stroke, robotics, exosuit, lower-limbs, rehabilitation, assistance, usability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- MyoSwiss AG
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
The Myosuit device is a wearable exosuit capable to provide assistance during the walk, sit to stand transition and stair climb [9]. Its assistance is provided with an exo-tendon mechanism. More in detail, online analysis of inertial signals allows to segment the gait phases and to assist at the extension of the knee and hip [9].
Many previous studies show promising results in the deambulation of spinal cord injuries or patients with lower-limb disorders [9,10]. These results were evaluated both in terms of kinematics and the safety of the patients. However, the studies conducted to highlight the urgency for the validation of the device in bigger and different cohorts [9,10].
Given this framework, the aim of this work is to conduct a pilot study on the effects of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The effects of the device will be analysed in terms of usability of the device, self-efficacy, and functional parameters of gait.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower limbs robotic intervention | Experimental | Device: Lower-limb robotic interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- 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°;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower-limb robotic interventionThe 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. | Device | Lower limbs robotic intervention |
Primary outcome
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
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
10 secondary outcomes
Variation of functional status after the treatment
Time frame: 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
Time frame: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Variation of walking capabilities after the treatment
Time frame: 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
Time frame: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Variation of walking capabilities after the treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Variation of gait kinematic after the treatment
Time frame: 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
Time frame: Evaluated at session 1 (before the beginning of the treatment) with and without the device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 34487721GBD 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.
- Background: PubMed 25162455Ammann 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.
- Background: PubMed 33281619Farrell 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.
- Background: PubMed 20945810Opara JA, Jaracz K. Quality of life of post-stroke patients and their caregivers. J Med Life. 2010 Jul-Sep;3(3):216-20.
- Background: PubMed 22261814Brands 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.
- Background: PubMed 17943883French 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.
- Background: PubMed 28488268Mehrholz 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.
- Background: PubMed 31623545Lee 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.
- Background: PubMed 29163120Schmidt 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.
- Background: PubMed 33032627Haufe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower-limb robotic intervention in people with Stroke and Ischemic Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the device (time frame: Evaluated at session 10 (after the treatment) at an average of 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579197, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.