LEAP a New Overground Body Weight Support Robot: Usability Trial (LEAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis; Cerebral Palsy; Parkinson Disease; Spinal Cord Injuries; People With Impaired Lower Extremity Function
• Intervention / Treatment: Device: Therapist LEAP session feedback; Device: Participant LEAP session feedback; Device: LEAP risk control validation

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Valais
    • Sion, Valais, Switzerland, 1951
      • Clinique Romande de Réadaptation (CRR), SUVAcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: LEAP usability; Therapist LEAP session feedback; Participant LEAP session feedback; LEAP risk control validation

Device: Therapist LEAP session feedback; 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.; Device: Participant LEAP session feedback; 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.; Device: LEAP risk control validation; The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinique Romande de Readaptation
• Investigators: Principal Investigator: Urs Keller, PhD, Ecole Polytechnique Fédérale de Lausanne

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): April 30, 2018

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (ACTUAL): March 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Brain Damage, Chronic; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Trauma, Nervous System; Spinal Cord Diseases; Multiple Sclerosis; Cerebral Palsy; Parkinson Disease; Body Weight; Spinal Cord Injuries
• Other Study ID Numbers: CliniqueRR-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No