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

Primary Purpose

Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Therapist LEAP session feedback
Participant LEAP session feedback
LEAP risk control validation
Sponsored by
Clinique Romande de Readaptation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinique Romande de Réadaptation (CRR), SUVAcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LEAP usability

Arm Description

Therapist LEAP session feedback Participant LEAP session feedback LEAP risk control validation

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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.
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.
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)
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)
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)

Secondary Outcome Measures

Robot Measurement - Patient position
The robot records the patient position in the room (in meters).
Robot Measurement - Walking speed
The robot records the walking speed (in meters per second).
Robot Measurement - Occurred errors
The robot records the errors occurred (error number).
Robot Measurement - Support forces
The robot records the support forces (in Newton).
Robot Measurement - Fall detection
The robot records the number of detected falls (Amount of detected falls).
Robot Measurement - Walked distance
The robot records the distance the patient walked during the session (in meters).
EMG system
Upon availability, an EMG system will be used to measure muscle activity during the session.
Patient characteristics - Testing date
The testing date (day/month/year) is being recorded.
Patient characteristics - Identification number
A unique participant identification number is being recorded.
Patient characteristics - Body height
The body height (in cm) is being recorded.
Patient characteristics - Body weight
The body weight (in kg) is being recorded.
Patient characteristics - Waist size
The waist size (in cm) is being recorded.
Patient characteristics - Tight circumference
The tight circumference (in cm) is being recorded.
Patient characteristics - Chest size
The chest size (in cm) is being recorded.
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.
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.
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.
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.
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.).
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).
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).

Full Information

First Posted
December 21, 2017
Last Updated
January 29, 2019
Sponsor
Clinique Romande de Readaptation
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1. Study Identification

Unique Protocol Identification Number
NCT03458169
Brief Title
LEAP a New Overground Body Weight Support Robot: Usability Trial
Acronym
LEAP
Official Title
Usability of a New Overground Body Weight Support Rehabilitation Robot LEAP: A Monocentric Consideration-of-concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Romande de Readaptation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease, Multiple Sclerosis, Stroke, People With Impaired Lower Extremity Function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEAP usability
Arm Type
Experimental
Arm Description
Therapist LEAP session feedback Participant LEAP session feedback LEAP risk control validation
Intervention Type
Device
Intervention Name(s)
Therapist LEAP session feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Participant LEAP session feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LEAP risk control validation
Intervention Description
The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.
Primary Outcome Measure Information:
Title
Usability of the robot - Fixation
Description
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
Title
Usability of the robot - Applicability
Description
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
Title
Usability of the robot - Robot support
Description
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
Title
Usability of the robot - User interface
Description
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
Title
Usability of the robot - Interaction
Description
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
Title
Risk control validation - Observer
Description
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
Title
Risk control validation - User
Description
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
Title
Participant feeling of safety/comfort - Fixation
Description
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
Title
Participant feeling of safety/comfort - Robot training
Description
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
Title
Participant feeling of safety/comfort - Robot support
Description
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
Secondary Outcome Measure Information:
Title
Robot Measurement - Patient position
Description
The robot records the patient position in the room (in meters).
Time Frame
1 hour
Title
Robot Measurement - Walking speed
Description
The robot records the walking speed (in meters per second).
Time Frame
1 hour
Title
Robot Measurement - Occurred errors
Description
The robot records the errors occurred (error number).
Time Frame
1 hour
Title
Robot Measurement - Support forces
Description
The robot records the support forces (in Newton).
Time Frame
1 hour
Title
Robot Measurement - Fall detection
Description
The robot records the number of detected falls (Amount of detected falls).
Time Frame
1 hour
Title
Robot Measurement - Walked distance
Description
The robot records the distance the patient walked during the session (in meters).
Time Frame
1 hour
Title
EMG system
Description
Upon availability, an EMG system will be used to measure muscle activity during the session.
Time Frame
1 hour
Title
Patient characteristics - Testing date
Description
The testing date (day/month/year) is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Identification number
Description
A unique participant identification number is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Body height
Description
The body height (in cm) is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Body weight
Description
The body weight (in kg) is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Waist size
Description
The waist size (in cm) is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Tight circumference
Description
The tight circumference (in cm) is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Chest size
Description
The chest size (in cm) is being recorded.
Time Frame
1 minutes
Title
Patient characteristics - Age
Description
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
Title
Patient characteristics - Stationary or ambulant
Description
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
Title
Patient characteristics - Dominant side
Description
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
Title
Patient characteristics - Walking aid
Description
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
Title
Patient characteristics - Six minute walking test
Description
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
Title
Patient characteristics - BAECKE score
Description
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
Title
Patient characteristics - Fugl-Meyer score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs Keller, PhD
Organizational Affiliation
Ecole Polytechnique Fédérale de Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Romande de Réadaptation (CRR), SUVAcare
City
Sion
State/Province
Valais
ZIP/Postal Code
1951
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
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LEAP a New Overground Body Weight Support Robot: Usability Trial

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