Clinical trial NCT03458169: LEAP a New Overground Body Weight Support Robot: Usability Trial
Official title: Usability of a New Overground Body Weight Support Rehabilitation Robot LEAP: A Monocentric Consideration-of-concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Cerebral Palsy
Parkinson Disease
Multiple Sclerosis
Stroke
People With Impaired Lower Extremity Function
Lead sponsor: Clinique Romande de Readaptation
Sponsor class: NETWORK
First posted: 2018-03-08
Enrollment: 43
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Usability of the robot - Fixation
timeFrame: 2 minutes
measure: Usability of the robot - Applicability
timeFrame: 2 minutes
measure: Usability of the robot - Robot support
timeFrame: 2 minutes
measure: Usability of the robot - User interface
timeFrame: 2 minutes
measure: Usability of the robot - Interaction
timeFrame: 2 minutes
measure: Risk control validation - Observer
timeFrame: 1 hour
measure: Risk control validation - User
timeFrame: 1 hour
measure: Participant feeling of safety/comfort - Fixation
timeFrame: 1 minute
measure: Participant feeling of safety/comfort - Robot training
timeFrame: 1 minute
measure: Participant feeling of safety/comfort - Robot support
timeFrame: 1 minute
Secondary outcomes:
measure: Robot Measurement - Patient position
timeFrame: 1 hour
measure: Robot Measurement - Walking speed
timeFrame: 1 hour
measure: Robot Measurement - Occurred errors
timeFrame: 1 hour
measure: Robot Measurement - Support forces
timeFrame: 1 hour
measure: Robot Measurement - Fall detection
timeFrame: 1 hour
measure: Robot Measurement - Walked distance
timeFrame: 1 hour
measure: EMG system
timeFrame: 1 hour
measure: Patient characteristics - Testing date
timeFrame: 1 minutes
measure: Patient characteristics - Identification number
timeFrame: 1 minutes
measure: Patient characteristics - Body height
timeFrame: 1 minutes
measure: Patient characteristics - Body weight
timeFrame: 1 minutes
measure: Patient characteristics - Waist size
timeFrame: 1 minutes
measure: Patient characteristics - Tight circumference
timeFrame: 1 minutes
measure: Patient characteristics - Chest size
timeFrame: 1 minutes
measure: Patient characteristics - Age
timeFrame: 1 minutes
measure: Patient characteristics - Stationary or ambulant
timeFrame: 1 minutes
measure: Patient characteristics - Dominant side
timeFrame: 1 minutes
measure: Patient characteristics - Walking aid
timeFrame: 1 minutes
measure: Patient characteristics - Six minute walking test
timeFrame: 1 minutes
measure: Patient characteristics - BAECKE score
timeFrame: 1 minutes
measure: Patient characteristics - Fugl-Meyer score
timeFrame: 1 minutes
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Clinique Romande de Réadaptation (CRR), SUVAcare
state: Valais
Study officials:
affiliation: Ecole Polytechnique Fédérale de Lausanne
name: Urs Keller, PhD
role: PRINCIPAL_INVESTIGATOR
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