An interventional study of Therapist LEAP session feedback and Participant LEAP session feedback in Spinal Cord Injuries, Cerebral Palsy and Parkinson Disease, sponsored by Clinique Romande de Readaptation. Completed at 1 site in Switzerland. Open to participants aged 5 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Clinique Romande de Readaptation · Not applicable, Interventional, and Other
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.
Healthy participants fulfilling all of the following inclusion criteria are eligible for the study:
Patients fulfilling all of the following inclusion criteria are eligible for the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant, for example:
* Therapist LEAP session feedback * Participant LEAP session feedback * LEAP risk control validation
Device: Therapist LEAP session feedback · Device: Participant LEAP session feedback · Device: LEAP risk control validation
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.
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.
The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 minute
Robot Measurement - Patient position
The robot records the patient position in the room (in meters).
Time frame: 1 hour
Robot Measurement - Walking speed
The robot records the walking speed (in meters per second).
Time frame: 1 hour
Robot Measurement - Occurred errors
The robot records the errors occurred (error number).
Time frame: 1 hour
Robot Measurement - Support forces
The robot records the support forces (in Newton).
Time frame: 1 hour
Robot Measurement - Fall detection
The robot records the number of detected falls (Amount of detected falls).
Time frame: 1 hour
Robot Measurement - Walked distance
The robot records the distance the patient walked during the session (in meters).
Time frame: 1 hour
EMG system
Upon availability, an EMG system will be used to measure muscle activity during the session.
Time frame: 1 hour
Patient characteristics - Testing date
The testing date (day/month/year) is being recorded.
Time frame: 1 minutes
Patient characteristics - Identification number
A unique participant identification number is being recorded.
Time frame: 1 minutes
Patient characteristics - Body height
The body height (in cm) is being recorded.
Time frame: 1 minutes
Patient characteristics - Body weight
The body weight (in kg) is being recorded.
Time frame: 1 minutes
Patient characteristics - Waist size
The waist size (in cm) is being recorded.
Time frame: 1 minutes
Patient characteristics - Tight circumference
The tight circumference (in cm) is being recorded.
Time frame: 1 minutes
Patient characteristics - Chest size
The chest size (in cm) is being recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: 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).
Time frame: 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).
Time frame: 1 minutes
Plan to share: No
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Clinique Romande de Readaptation