LEAP a New Overground Body Weight Support Robot: Usability Trial
- Conditions
- Spinal Cord InjuriesMultiple SclerosisPeople With Impaired Lower Extremity FunctionCerebral PalsyParkinson DiseaseStroke
- Interventions
- Device: Therapist LEAP session feedbackDevice: Participant LEAP session feedbackDevice: LEAP risk control validation
- Registration Number
- NCT03458169
- Lead Sponsor
- Clinique Romande de Readaptation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LEAP usability LEAP risk control validation * Therapist LEAP session feedback * Participant LEAP session feedback * LEAP risk control validation LEAP usability Participant LEAP session feedback * Therapist LEAP session feedback * Participant LEAP session feedback * LEAP risk control validation LEAP usability Therapist LEAP session feedback * Therapist LEAP session feedback * Participant LEAP session feedback * LEAP risk control validation
- Primary Outcome Measures
Name Time Method Usability of the robot - Robot support 2 minutes 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)Usability of the robot - Fixation 2 minutes 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)Usability of the robot - Applicability 2 minutes 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)Usability of the robot - Interaction 2 minutes 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)Risk control validation - User 1 hour 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.Usability of the robot - User interface 2 minutes 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)Risk control validation - Observer 1 hour 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.Participant feeling of safety/comfort - Robot support 1 minute From the participant information on the comfort/safety is being assessed (CRF II):
Feedback on the robot support (Ordinal scale from 0 to 5)Participant feeling of safety/comfort - Fixation 1 minute From the participant information on the comfort/safety is being assessed (CRF II):
Feedback on the fixation of the patient (Open-ended question)Participant feeling of safety/comfort - Robot training 1 minute From the participant information on the comfort/safety is being assessed (CRF II):
Feedback on the robot training (Ordinal scale from 0 to 5)
- Secondary Outcome Measures
Name Time Method Patient characteristics - Identification number 1 minutes A unique participant identification number is being recorded.
Robot Measurement - Patient position 1 hour The robot records the patient position in the room (in meters).
Robot Measurement - Occurred errors 1 hour The robot records the errors occurred (error number).
Robot Measurement - Fall detection 1 hour The robot records the number of detected falls (Amount of detected falls).
EMG system 1 hour Upon availability, an EMG system will be used to measure muscle activity during the session.
Patient characteristics - Body height 1 minutes The body height (in cm) is being recorded.
Patient characteristics - Body weight 1 minutes The body weight (in kg) is being recorded.
Patient characteristics - Tight circumference 1 minutes The tight circumference (in cm) is being recorded.
Patient characteristics - Stationary or ambulant 1 minutes 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.
Robot Measurement - Walking speed 1 hour The robot records the walking speed (in meters per second).
Robot Measurement - Support forces 1 hour The robot records the support forces (in Newton).
Robot Measurement - Walked distance 1 hour The robot records the distance the patient walked during the session (in meters).
Patient characteristics - Testing date 1 minutes The testing date (day/month/year) is being recorded.
Patient characteristics - Waist size 1 minutes The waist size (in cm) is being recorded.
Patient characteristics - Chest size 1 minutes The chest size (in cm) is being recorded.
Patient characteristics - Age 1 minutes 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.
Patient characteristics - Dominant side 1 minutes 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.
Patient characteristics - Walking aid 1 minutes 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.Patient characteristics - Six minute walking test 1 minutes 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.).
Patient characteristics - BAECKE score 1 minutes 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).
Patient characteristics - Fugl-Meyer score 1 minutes 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).
Trial Locations
- Locations (1)
Clinique Romande de Réadaptation (CRR), SUVAcare
🇨ðŸ‡Sion, Valais, Switzerland