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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
Full 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.
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15 participants in 1 patient group
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Carmel Tulen, Bsc.; Liliana Paredes, Dr.
Data sourced from clinicaltrials.gov
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