LEAP a New Overground Body Weight Support Robot: Usability Trial

Study Overview
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Brief Summary
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People with central nervous system disorders such as spinal cord injury, stroke, cerebral palsy, Parkinson's disease, multiple sclerosis, etc… often have impaired lower extremity function that limits activities of daily life and independence. Different body-weight support systems have been developed to facilitate the rehabilitation process by compensating for the user's residual abilities. However, studies on weight-supported gait training on a treadmill have failed to show superiority over conventional rehabilitation programs for spinal cord injury and stroke. A recent study by the group around Grégoire Courtine showed that body-weight support systems that provide assistance only in the vertical direction disrupt the production of gait and balance, suggesting that current practices may even be detrimental for relearning to walk. For the past year, the Clinique Romande de Réadaptation (CRR) worked together with the G-Lab at EPFL and G-Therapeutics on a new robot platform specifically developed to provide adjustable trunk support along four independent degrees of freedom (LEAP). The investigators were able to draw on their long-term experience, which consists of different body weight support training systems for stroke and spinal cord injury. This knowledge, combined with the input of our therapists and physicians and the specific requirements for people with neurological/musculoskeletal disorders, has resulted in a design that can provide adjustable bodyweight support during over-ground locomotion, treadmill, stairs training, standing up and sitting down and for support during the training of activities of daily living. The scope of this study is to examine how well the robot can be used for rehabilitation therapy in everyday clinical practice. This includes, among other things, technical aspects such as the handling of the hardware, the adaptability of the robot to the patient, and the safety during operation (such as the fall prevention). Various patient-specific aspects will also be evaluated e.g. comfort, positioning, or motivation of the patient. This study also aims to evaluate the software with the various support modes, operating options, and the user interface of the LEAP.

Official Title
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Usability of a New Overground Body Weight Support Rehabilitation Robot LEAP: A Monocentric Consideration-of-concept Trial

Conditions
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Stroke, Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease, Multiple Sclerosis, People With Impaired Lower Extremity Function

Intervention / Treatment
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* Device: Therapist LEAP session feedback
* Device: Participant LEAP session feedback
* Device: LEAP risk control validation


Participation Criteria
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Eligibility Criteria
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Healthy participants fulfilling all of the following inclusion criteria are eligible for the study: The healthy volunteer or legal representative has been informed and has signed the informed consent form Age 18-80 or age 5-10 (women or men) Weight below 137 kg Height between 120 and 190 cm Agree to comply in good faith with all conditions of the study and to attend all required training Patients fulfilling all of the following inclusion criteria are eligible for the study: The patient has been informed and has signed the informed consent form Age 18-80 (women or men) Weight below 137 kg Height between 120 and 190 cm Neurological/musculoskeletal diagnoses Impairment of the lower extremities Stable medical and physical condition as considered by the attending doctor or physician Agree to comply in good faith with all conditions of the study and to attend all required training Other (non-neurological) diagnoses, who require intense training of the lower extremities The rehabilitation physician or doctor provides a final agreement whether the participant can train with the LEAP The presence of any one of the following exclusion criteria will lead to exclusion of the participant, for example: Strong adipositas, which makes it not possible to adjust the harness to the anthropometrics of the participant Bracing of the spinal column. Severe joint contractures disabling or restricting lower limb movements Instabilities of bones or joints, fractures or osteoporosis/osteopenia Allergy against material of harness Open skin lesions Luxations or subluxations of joints that should be positioned in LEAP Strong pain Strong spontaneous movements like ataxia, dyskinesia, myoclonus* Instable vital functions like pulmonal or cardiovascular conditions Uncooperative or aggressive behaviour Severe cognitive deficits Inability to signal pain or discomfort Apraxia* Severe spasticity (Ashworth 4) Severe epilepsy* Insufficient head stability Infections requiring isolation of the patient History of significant autonomic dysreflexia Systemic malignant disorders Cardiovascular disorders restricting physical training Peripheral nerve disorders Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results. Known or suspected non-compliance, drug or alcohol abuse, Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, Participation in another study with investigational drug within the 30 days preceding and during the present study Previous enrolment into the current study Contraindications marked with an * are relative contraindications. Final approval needs to be obtained from the attending medical doctor.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEAP usability<br>Therapist LEAP session feedback Participant LEAP session feedback LEAP risk control validation | Device: Therapist LEAP session feedback<br>* A standard therapy session is being performed with a participant with the LEAP body-weight support robot. Subsequently, the therapist is answering a questionnaire to assess the clinical applicability of the robot. An observer will assess with a questionnaire whether use errors occurred during the session.<br>Device: Participant LEAP session feedback<br>* A standard therapy session is being performed with a participant inside the LEAP body-weight support robot. Subsequently, the participant is answering a questionnaire to assess the comfort of the robot.<br>Device: LEAP risk control validation<br>* The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the robot - Fixation | From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on patient/subject fixation (Ordinal scale from 1:useful to 5:not useful) | 2 minutes | 
| Usability of the robot - Applicability | From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on clinical applicability (Ordinal scale from 1:useful to 5:not useful) | 2 minutes | 
| Usability of the robot - Robot support | From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on robot support (Ordinal scale from 1:useful to 5:not useful) | 2 minutes | 
| Usability of the robot - User interface | From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on user interface (Graphical user interface) (Ordinal scale from 1:useful to 5:not useful) | 2 minutes | 
| Usability of the robot - Interaction | From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on the LEAP interaction (Ordinal scale from 1:useful to 5:not useful) | 2 minutes | 
| Risk control validation - Observer | From an independent observer (investigator, or a member of the development team) the occurrence of use errors is recorded (CRF III): Each primary operating function of the robot is rated (Ordinal scale from 0 to 1 for 'use error occurred' or 'no use error' This questionnaire has only to be filled out once for each user/therapist. | 1 hour | 
| Risk control validation - User | The risk control measures are validated by the user/therapist (CRF IV): The different risk controls are rated (Ordinal scale from 0 to 1 for 'Acceptable' or 'Not acceptable') This questionnaire has only to be filled out once by each user/therapist. | 1 hour | 
| Participant feeling of safety/comfort - Fixation | From the participant information on the comfort/safety is being assessed (CRF II): Feedback on the fixation of the patient (Open-ended question) | 1 minute | 
| Participant feeling of safety/comfort - Robot training | From the participant information on the comfort/safety is being assessed (CRF II): Feedback on the robot training (Ordinal scale from 0 to 5) | 1 minute | 
| Participant feeling of safety/comfort - Robot support | From the participant information on the comfort/safety is being assessed (CRF II): Feedback on the robot support (Ordinal scale from 0 to 5) | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Robot Measurement - Patient position | The robot records the patient position in the room (in meters). | 1 hour | 
| Robot Measurement - Walking speed | The robot records the walking speed (in meters per second). | 1 hour | 
| Robot Measurement - Occurred errors | The robot records the errors occurred (error number). | 1 hour | 
| Robot Measurement - Support forces | The robot records the support forces (in Newton). | 1 hour | 
| Robot Measurement - Fall detection | The robot records the number of detected falls (Amount of detected falls). | 1 hour | 
| Robot Measurement - Walked distance | The robot records the distance the patient walked during the session (in meters). | 1 hour | 
| EMG system | Upon availability, an EMG system will be used to measure muscle activity during the session. | 1 hour | 
| Patient characteristics - Testing date | The testing date (day/month/year) is being recorded. | 1 minutes | 
| Patient characteristics - Identification number | A unique participant identification number is being recorded. | 1 minutes | 
| Patient characteristics - Body height | The body height (in cm) is being recorded. | 1 minutes | 
| Patient characteristics - Body weight | The body weight (in kg) is being recorded. | 1 minutes | 
| Patient characteristics - Waist size | The waist size (in cm) is being recorded. | 1 minutes | 
| Patient characteristics - Tight circumference | The tight circumference (in cm) is being recorded. | 1 minutes | 
| Patient characteristics - Chest size | The chest size (in cm) is being recorded. | 1 minutes | 
| Patient characteristics - Age | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): The age of the participant (in years, decimal) is being recorded. | 1 minutes | 
| Patient characteristics - Stationary or ambulant | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): It will be recorded whether the patient is stationary or ambulant. | 1 minutes | 
| Patient characteristics - Dominant side | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): The dominant body side (left or right) is being recorded. | 1 minutes | 
| Patient characteristics - Walking aid | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): If applicable: The type of walking aid (open-ended question) is being recorded. | 1 minutes | 
| Patient characteristics - Six minute walking test | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): Upon availability the outcome of the Six-minute walking test will be recorded (distance in meters. Longer distance corresponds to a better outcome.). | 1 minutes | 
| Patient characteristics - BAECKE score | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): BAECKE physical activity questionnaire (Score between 0: no activity, and 10: high activity). | 1 minutes | 
| Patient characteristics - Fugl-Meyer score | The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): Lower limb subset of the Fugl-Meyer score. Fugl-Meyer assessment measures the sensorimotor function. (Score between 0: no function and 34: full functionality). | 1 minutes |