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

January 29, 2019 updated by: Clinique Romande de Readaptation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Usability of the robot - Fixation
Time Frame: 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)
2 minutes
Usability of the robot - Applicability
Time Frame: 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)
2 minutes
Usability of the robot - Robot support
Time Frame: 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)
2 minutes
Usability of the robot - User interface
Time Frame: 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)
2 minutes
Usability of the robot - Interaction
Time Frame: 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)
2 minutes
Risk control validation - Observer
Time Frame: 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.
1 hour
Risk control validation - User
Time Frame: 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.
1 hour
Participant feeling of safety/comfort - Fixation
Time Frame: 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)
1 minute
Participant feeling of safety/comfort - Robot training
Time Frame: 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)
1 minute
Participant feeling of safety/comfort - Robot support
Time Frame: 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)
1 minute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Robot Measurement - Patient position
Time Frame: 1 hour
The robot records the patient position in the room (in meters).
1 hour
Robot Measurement - Walking speed
Time Frame: 1 hour
The robot records the walking speed (in meters per second).
1 hour
Robot Measurement - Occurred errors
Time Frame: 1 hour
The robot records the errors occurred (error number).
1 hour
Robot Measurement - Support forces
Time Frame: 1 hour
The robot records the support forces (in Newton).
1 hour
Robot Measurement - Fall detection
Time Frame: 1 hour
The robot records the number of detected falls (Amount of detected falls).
1 hour
Robot Measurement - Walked distance
Time Frame: 1 hour
The robot records the distance the patient walked during the session (in meters).
1 hour
EMG system
Time Frame: 1 hour
Upon availability, an EMG system will be used to measure muscle activity during the session.
1 hour
Patient characteristics - Testing date
Time Frame: 1 minutes
The testing date (day/month/year) is being recorded.
1 minutes
Patient characteristics - Identification number
Time Frame: 1 minutes
A unique participant identification number is being recorded.
1 minutes
Patient characteristics - Body height
Time Frame: 1 minutes
The body height (in cm) is being recorded.
1 minutes
Patient characteristics - Body weight
Time Frame: 1 minutes
The body weight (in kg) is being recorded.
1 minutes
Patient characteristics - Waist size
Time Frame: 1 minutes
The waist size (in cm) is being recorded.
1 minutes
Patient characteristics - Tight circumference
Time Frame: 1 minutes
The tight circumference (in cm) is being recorded.
1 minutes
Patient characteristics - Chest size
Time Frame: 1 minutes
The chest size (in cm) is being recorded.
1 minutes
Patient characteristics - Age
Time Frame: 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.
1 minutes
Patient characteristics - Stationary or ambulant
Time Frame: 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.
1 minutes
Patient characteristics - Dominant side
Time Frame: 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.
1 minutes
Patient characteristics - Walking aid
Time Frame: 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.
1 minutes
Patient characteristics - Six minute walking test
Time Frame: 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.).
1 minutes
Patient characteristics - BAECKE score
Time Frame: 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).
1 minutes
Patient characteristics - Fugl-Meyer score
Time Frame: 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).
1 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinique Romande de Readaptation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Urs Keller, PhD, Ecole Polytechnique Fédérale de Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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