Neurologic Gait DisorderNCT05485597
Myosuit-based Gait Training
A study testing Myosuit-based gait training in people with Neurologic Gait Disorder, run by Rehaklinik Zihlschlacht AG at 1 site in Switzerland.
Trial summary
This study will investigate the safety and feasibility of over-ground training sessions with the Myosuit for the neurological inpatients of rehabilitation clinic Zihlschlacht with a gait disorder and their therapists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Gait Disorder
- What is being tested?
- Myosuit-based gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2022to 31 Dec 2022
- 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
- FAC score between 2 and 4
- Intact or mildly to moderately impaired cognition: Mini Mental State Examination (MMSE) score above 17 points
- Subject is at least 18 years old
- A height between 150 cm and 195 cm
- A weight between 45 to 110 kg
Who cannot join
- Specific neurological disorders such as Parkinson's disease and Multiple sclerosis
- Neurological patients without gait disorders
- Unstable cardiovascular and respiratory conditions
- Functional Reach Test < 15.24 cm
- 10MWT not possible with the assistance of a person
- Major musculoskeletal conditions (e.g., rheumatoid arthritis), major limited lower extremity's range of motion, orthopedic problems and/or significant lower extremity joint pain that could affect the application of the Myosuit
Show all 13Show fewer
- Significant lower limb contractures (knee flexion or hip flexion contracture of >10°, Varus deformity >10°, Valgus deformity >10°) that could affect the application of the Myosuit
- Skin integrity (on surfaces that would contact the device)
- Significant osteoporosis (bone fragility) assessed by a medical doctor
- Pregnancy
- Incapacity to (safely) understand and/or follow instructions (e.g., aphasia, limited knowledge of German)
- Incapacity to understand formal consent
- Currently participating in other (internal) interventional studies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Rehaklinik Zihlschlacht AG
Zihlschlacht-Sitterdorf, 8588
Liliana Paredes, Dr., +41714243730, l.paredes@rehaklinik-zihlschlacht.ch
Carmel Tulen, BSc.
About this study
Official title: Usability and Feasibility Study of Myosuit-based Gait Training for Ambulatory Neurological Patients With Gait Disorders
This study will investigate the safety and feasibility of over-ground training sessions with the Myosuit for the neurological inpatients of rehabilitation clinic Zihlschlacht with a gait disorder and their therapists. It will also examine the acceptability and motivation of patients and therapists to use the device for training in the clinical setting and at home or community level. Moreover, it will present first results of the training efficacy with the Myosuit in the inpatient setting on the mobility level of the International Classification of Function. The proposed trial is designed as an open-label, non-randomized interventional study
Read the detailed description
Neurological disorders are the leading cause of long-term disability in adults worldwide. The activity most affected by a neurological disease is walking. Gait disorders occur in approximately 60% of patients hospitalized for a neurological disease and are the first step toward immobility and loss of independence. Not reaching the walking speed, which is necessary to walk safely outside, hinders social (re)integration and the ability to participate in society. As a result, many neurological patients with gait disorders experience a significantly reduced health-related quality of life. Soft, lightweight wearable robots appear to be good candidates for supporting physical therapy in a clinical environment and improving functional mobility in outdoor settings and as assistive devices during activities of daily living within a home-based environment. The integration of these robots into home-based rehabilitation programs could greatly contribute to increasing the patient's activity level and social interaction, which increases the health-related quality of life in chronic neurological patients. The Investigators want to integrate this new form of therapy in the rehabilitation programme from inpatient to home setting with the aim of maintaining and/or improving patients' functional ambulatory ability and enable them to perform activities of daily living more independently. This research aims to evaluate the usability of the innovative wearable robot 'the Myosuit" and the feasibility of this new form of therapy in the inpatient setting. The investigators will also measure qualitatively and quantitatively the patients' motivation to want to continue using the device for the home training and the staff's motivation to recommend the training with this device in the home setting. Furthermore, the investigators will evaluate the staff's judgment on the feasibility of recommending the Myosuit for home-training.
In a time period of four weeks participants will undergo eight individual task-specific overground gait training sessions with the Myosuit.The inpatient training sessions will be started with a therapist, and if possible and as soon as possible, the patient will continue training with an assistant of therapy. Both therapists and assistants will be trained with the device before the study begins. The investigators introduce the training with assistants as an important step for transferring the inpatient training to the home setting where the relatives will assist the patients in the training with the Myosuit and they will have no background in physiotherapy as it is the case of the assistants in this study. The investigators assume that if the inpatient training is possible with therapists and subsequently with the assistants, it will be certainly feasible with the relatives.
For this study, the Myosuit (MyoSwiss AG, Zurich, Switzerland) will be used. The Myosuit is CE-Marked (Conformité Européenne; in accordance with European legislation), with reference number 1910001. The Myosuit is an untethered wearable robot designed to assist the essential mobility functions across activities of daily life, such as walking, standing, sitting, making transfers or climbing stairs. The Myosuit actively supports knee and hip extension in the early- to mid-stance phase of the gait cycle and passively aids hip flexion during swing, using elastic rubber bands
All the participants will be recruited from inpatients of Rehabilitation clinic Zihlschlacht by qualified (physio)therapists. The study participants will receive sufficient information about the study design and the risks and benefits of their participation. Patients have to meet defined physical requirements. To screen whether the patients meet these physical (manufacturer's recommendations) requirements, for the safety and feasibility of using the Myosuit, a clinical evaluation will be undertaken prior to the training period. In addition, to be included in the study, participants must meet the study inclusion and exclusion criteria It is planned to recruit 15 ambulatory neurological patients with gait disorder. The estimated duration is 5 months.
Mainly descriptive statistics will be performed in order to analyze the obtained data. Normal distribution will be determined visually by quantile-quantile plots and numerically by Shapiro-Wilk Normality Test. Matched-paired tests will be used to examine differences in pre-test and post-test scores. Associations between paired samples will be measured by either Spearman's rho or Pearson correlation coefficient depending on normality. Effect size will be calculated in order to measure meaningful differences between pre-test and post-test scores. A two-sided p value of <0.05 is considered statistically significant. All analyses are going to be performed using IBM® SPSS® Statistics and MATLAB and Statistics Toolbox, The MathWorks, Inc., Natick, Massachusetts, United States.
- Conditions
- Neurologic Gait Disorder
- Being tested
- Myosuit-based gait training
- Keywords
- Exosuit, Training, Rehabilitation
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myosuit-based gait trainingDevice
In a period of four weeks participants will undergo eight individual task-specific overground gait training sessions with the Myosuit. The sessions will be started with a therapist, and if possible and as soon as possible, the patient will train with an assistant. During the therapy sessions, the patient will be asked to perform various task-specific exercises with the Myosuit, such as Sit-to-stand-, Balance- and walking exercises. Depending on the individual skill level of the participant, a higher level of difficulty in task-specific exercises can be performed. The training sessions are set to last 45 minutes. All training sessions will be accompanied by a certified (physio)therapist or trained assistant and a study investigator.
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Neurological inpatients with Gait disorders | Experimental | The group participates in the study intervention (they will undergo the Myosuit-based gait training) Receives: Device: Myosuit-based gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the Myosuit during task specific training
The usability will be measured with the System Usability Scale (SUS). The SUS questionnaire will be completed by the participants, as well as therapists and therapy assistants. The SUS is an easy, valid and reliable tool for measuring the usability of a device. It consists of a 10-item questionnaire about the usability of a device with five response options for respondents; from strongly agree to strongly disagree. A score above 68 can be considered above average and anything below 68 is below average.
Measured: 4 weeks
Usability of the Myosuit during task specific training
The usability will be measured with the Usefulness, Satisfaction, and Ease of use Questionnaire (USE). The USE questionnaire will be completed by the participants, as well as therapists and therapy assistants. The USE measures the subjective usability of a product or service. It is a 30-item questionnaire that examines four dimensions of usability: usability, ease of use, ease of learning, and satisfaction. a higher score indicates better usability.
Measured: 4 weeks
Safety of the Myosuit during task specific training.
The safety will be analyzed by the risk of falling (near falls, falls and adverse events (AE)) and the change in walking speed, step length and cadence while performing the 10 Meter Walk Test (10MWT) with versus without the Myosuit.
Measured: 4 weeks
Secondary outcomes (6)
Motivation of patients to use the Myosuit during and after their inpatient rehabilitation
The motivation will be measured by conducting an interview with the participants
Measured: 4 weeks
Motivation of therapists to use the Myosuit as a facilitator for gait training.
The motivation will be measured by conducting an interview with the therapists
Measured: 4 weeks
Motivation of therapy assistants to use the Myosuit as a facilitator for gait training.
The motivation will be measured by conducting an interview with the therapy assistants
Measured: 4 weeks
Efficacy of the four-week Myosuit-based gait training on mobility
The mobility will be measured by the de Morton Mobility Index (DEMMI). The DEMMI is an assessment on an ordinal scale level, which can depict the mobility status of geriatric patients across the entire mobility spectrum by means of 15 items. It is hierarchically structured from easy to difficult. In five subcategories (bed, chair, static balance, walking, and dynamic balance) different activities are tested. Most items are rated with zero points or one point, depending on whether the activity can be performed (1) or not (0). For some items, a maximum of two points can be awarded in order to evaluate the level of support or the quantity of walking distance in a more differentiated way. The tester adds up the points to a raw score (max. 19 points) and converts this into the DEMMI score (0 to 100 points) for statistical reasons using a conversion table. In general, a higher score indicates better mobility.
Measured: 4 weeks
Efficacy of the four-week Myosuit-based gait training on walking speed
The walking parameter walking speed will be measured by the 10-Meter Walk Test (10MWT). The 10MWT is a performance measure used to assess walking speed in meters per second over a short distance. Walking speed < 0.70 m/s is indicative of increased risk of adverse events (fall, hospitalisation, fracture, etc.). A speed <0.40 m/s indicates a household ambulator, a speed between 0.40 and 0.80 m/s indicates a limited community ambulator and speed > 0.80 m/s indicates the possibility of a community ambulator.
Measured: 4 weeks
Efficacy of the four-week Myosuit-based gait training on walking capacity
The walking parameter walking capacity will be measured by the 6-Minute Walk Test (6MWT). The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the walked distance indicates improvement in basic mobility.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurologic Gait DisorderStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed trial is designed as an open-label, non-randomized interventional study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehaklinik Zihlschlacht AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485597
- Sponsor's protocol ID
- RZS_05_2022
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haufe FL, Kober AM, Schmidt K, Sancho-Puchades A, Duarte JE, Wolf P, Riener R. User-driven walking assistance: first experimental results using the MyoSuit. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:944-949. doi: 10.1109/ICORR.2019.8779375.
PubMed 31374751Haufe 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 33032627Wright A, Stone K, Martinelli L, Fryer S, Smith G, Lambrick D, Stoner L, Jobson S, Faulkner J. Effect of combined home-based, overground robotic-assisted gait training and usual physiotherapy on clinical functional outcomes in people with chronic stroke: A randomized controlled trial. Clin Rehabil. 2021 Jun;35(6):882-893. doi: 10.1177/0269215520984133. Epub 2020 Dec 27.
PubMed 33356519Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A. Effects of a wearable exoskeleton stride management assist system (SMA(R)) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2015 Aug 20;12:69. doi: 10.1186/s12984-015-0062-0.
PubMed 26289955Mehrholz 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 28488268
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Feasibility Study of Myosuit-based Gait Training for Ambulatory Neurological Patients With Gait Disorders
- ClinicalTrials.gov ID
- NCT05485597
- Acronym / sponsor ID
- RZS_05_2022
- Conditions
- Neurologic Gait Disorder
- Keywords
- Exosuit, Training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rehaklinik Zihlschlacht AGUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Aug 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.
This study will investigate the safety and feasibility of over-ground training sessions with the Myosuit for the neurological inpatients of rehabilitation clinic Zihlschlacht with a gait disorder and their therapists. It will also examine the acceptability and motivation of patients and therapists to use the device for training in the clinical setting and at home or community level. Moreover, it will present first results of the training efficacy with the Myosuit in the inpatient setting on the mobility level of the International Classification of Function. The proposed trial is designed as an open-label, non-randomized interventional study
Detailed description
Neurological disorders are the leading cause of long-term disability in adults worldwide. The activity most affected by a neurological disease is walking. Gait disorders occur in approximately 60% of patients hospitalized for a neurological disease and are the first step toward immobility and loss of independence. Not reaching the walking speed, which is necessary to walk safely outside, hinders social (re)integration and the ability to participate in society. As a result, many neurological patients with gait disorders experience a significantly reduced health-related quality of life. Soft, lightweight wearable robots appear to be good candidates for supporting physical therapy in a clinical environment and improving functional mobility in outdoor settings and as assistive devices during activities of daily living within a home-based environment. The integration of these robots into home-based rehabilitation programs could greatly contribute to increasing the patient's activity level and social interaction, which increases the health-related quality of life in chronic neurological patients. The Investigators want to integrate this new form of therapy in the rehabilitation programme from inpatient to home setting with the aim of maintaining and/or improving patients' functional ambulatory ability and enable them to perform activities of daily living more independently. This research aims to evaluate the usability of the innovative wearable robot 'the Myosuit" and the feasibility of this new form of therapy in the inpatient setting. The investigators will also measure qualitatively and quantitatively the patients' motivation to want to continue using the device for the home training and the staff's motivation to recommend the training with this device in the home setting. Furthermore, the investigators will evaluate the staff's judgment on the feasibility of recommending the Myosuit for home-training.
In a time period of four weeks participants will undergo eight individual task-specific overground gait training sessions with the Myosuit.The inpatient training sessions will be started with a therapist, and if possible and as soon as possible, the patient will continue training with an assistant of therapy. Both therapists and assistants will be trained with the device before the study begins. The investigators introduce the training with assistants as an important step for transferring the inpatient training to the home setting where the relatives will assist the patients in the training with the Myosuit and they will have no background in physiotherapy as it is the case of the assistants in this study. The investigators assume that if the inpatient training is possible with therapists and subsequently with the assistants, it will be certainly feasible with the relatives.
For this study, the Myosuit (MyoSwiss AG, Zurich, Switzerland) will be used. The Myosuit is CE-Marked (Conformité Européenne; in accordance with European legislation), with reference number 1910001. The Myosuit is an untethered wearable robot designed to assist the essential mobility functions across activities of daily life, such as walking, standing, sitting, making transfers or climbing stairs. The Myosuit actively supports knee and hip extension in the early- to mid-stance phase of the gait cycle and passively aids hip flexion during swing, using elastic rubber bands
All the participants will be recruited from inpatients of Rehabilitation clinic Zihlschlacht by qualified (physio)therapists. The study participants will receive sufficient information about the study design and the risks and benefits of their participation. Patients have to meet defined physical requirements. To screen whether the patients meet these physical (manufacturer's recommendations) requirements, for the safety and feasibility of using the Myosuit, a clinical evaluation will be undertaken prior to the training period. In addition, to be included in the study, participants must meet the study inclusion and exclusion criteria It is planned to recruit 15 ambulatory neurological patients with gait disorder. The estimated duration is 5 months.
Mainly descriptive statistics will be performed in order to analyze the obtained data. Normal distribution will be determined visually by quantile-quantile plots and numerically by Shapiro-Wilk Normality Test. Matched-paired tests will be used to examine differences in pre-test and post-test scores. Associations between paired samples will be measured by either Spearman's rho or Pearson correlation coefficient depending on normality. Effect size will be calculated in order to measure meaningful differences between pre-test and post-test scores. A two-sided p value of <0.05 is considered statistically significant. All analyses are going to be performed using IBM® SPSS® Statistics and MATLAB and Statistics Toolbox, The MathWorks, Inc., Natick, Massachusetts, United States.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed trial is designed as an open-label, non-randomized interventional study.
| Arm | Type | Receives |
|---|---|---|
| Study Group: Neurological inpatients with Gait disorders | Experimental | Device: Myosuit-based gait trainingThe group participates in the study intervention (they will undergo the Myosuit-based gait training) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- FAC score between 2 and 4
- Intact or mildly to moderately impaired cognition: Mini Mental State Examination (MMSE) score above 17 points
- Subject is at least 18 years old
- A height between 150 cm and 195 cm
- A weight between 45 to 110 kg
Key exclusion criteria (13 listed)
- Specific neurological disorders such as Parkinson's disease and Multiple sclerosis
- Neurological patients without gait disorders
- Unstable cardiovascular and respiratory conditions
- Functional Reach Test < 15.24 cm
- 10MWT not possible with the assistance of a person
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 |
|---|---|---|
| Myosuit-based gait trainingIn a period of four weeks participants will undergo eight individual task-specific overground gait training sessions with the Myosuit. The sessions will be started with a therapist, and if possible and as soon as possible, the patient will train with an assistant. During the therapy sessions, the patient will be asked to perform various task-specific exercises with the Myosuit, such as Sit-to-stand-, Balance- and walking exercises. Depending on the individual skill level of the participant, a higher level of difficulty in task-specific exercises can be performed. The training sessions are set to last 45 minutes. All training sessions will be accompanied by a certified (physio)therapist or trained assistant and a study investigator. | Device | Study Group: Neurological inpatients with Gait disorders |
Primary outcome
Usability of the Myosuit during task specific training
Time frame: 4 weeks
The usability will be measured with the System Usability Scale (SUS). The SUS questionnaire will be completed by the participants, as well as therapists and therapy assistants. The SUS is an easy, valid and reliable tool for measuring the usability of a device. It consists of a 10-item questionnaire about the usability of a device with five response options for respondents; from strongly agree to strongly disagree. A score above 68 can be considered above average and anything below 68 is below average.
Usability of the Myosuit during task specific training
Time frame: 4 weeks
The usability will be measured with the Usefulness, Satisfaction, and Ease of use Questionnaire (USE). The USE questionnaire will be completed by the participants, as well as therapists and therapy assistants. The USE measures the subjective usability of a product or service. It is a 30-item questionnaire that examines four dimensions of usability: usability, ease of use, ease of learning, and satisfaction. a higher score indicates better usability.
Safety of the Myosuit during task specific training.
Time frame: 4 weeks
The safety will be analyzed by the risk of falling (near falls, falls and adverse events (AE)) and the change in walking speed, step length and cadence while performing the 10 Meter Walk Test (10MWT) with versus without the Myosuit.
6 secondary outcomes
Motivation of patients to use the Myosuit during and after their inpatient rehabilitation
Time frame: 4 weeks
Motivation of therapists to use the Myosuit as a facilitator for gait training.
Time frame: 4 weeks
Motivation of therapy assistants to use the Myosuit as a facilitator for gait training.
Time frame: 4 weeks
Efficacy of the four-week Myosuit-based gait training on mobility
Time frame: 4 weeks
Efficacy of the four-week Myosuit-based gait training on walking speed
Time frame: 4 weeks
Efficacy of the four-week Myosuit-based gait training on walking capacity
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Results publication: PubMed 31374751Haufe FL, Kober AM, Schmidt K, Sancho-Puchades A, Duarte JE, Wolf P, Riener R. User-driven walking assistance: first experimental results using the MyoSuit. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:944-949. doi: 10.1109/ICORR.2019.8779375.
- Results publication: 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.
- Results publication: PubMed 33356519Wright A, Stone K, Martinelli L, Fryer S, Smith G, Lambrick D, Stoner L, Jobson S, Faulkner J. Effect of combined home-based, overground robotic-assisted gait training and usual physiotherapy on clinical functional outcomes in people with chronic stroke: A randomized controlled trial. Clin Rehabil. 2021 Jun;35(6):882-893. doi: 10.1177/0269215520984133. Epub 2020 Dec 27.
- Results publication: PubMed 26289955Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A. Effects of a wearable exoskeleton stride management assist system (SMA(R)) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2015 Aug 20;12:69. doi: 10.1186/s12984-015-0062-0.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myosuit-based gait training in people with Neurologic Gait Disorder, run by Rehaklinik Zihlschlacht AG at 1 site in Switzerland.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Aug 2022. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liliana Paredes, Dr. (+41714243730, l.paredes@rehaklinik-zihlschlacht.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Myosuit during task specific training (time frame: 4 weeks). The study lists 3 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 NCT05485597, which also lists 5 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 11 Aug 2022.