Neurologic Gait Disorder Clinical Trial
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
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
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Switzerland | Rehaklinik Zihlschlacht AG | Zihlschlacht-Sitterdorf |
Lead Sponsor | Collaborator |
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Rehaklinik Zihlschlacht AG |
Switzerland,
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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. — View Citation
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. — View Citation
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:CD006185. doi: 10.1002/14651858.CD006185.pub4. Review. Update in: Cochrane Database Syst Re — View Citation
Wright 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: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 weeks | |
Primary | 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. | 4 weeks | |
Primary | 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. | 4 weeks | |
Secondary | 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 | 4 weeks | |
Secondary | 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 | 4 weeks | |
Secondary | 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 | 4 weeks | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 4 weeks |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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