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Completed

NCT Number: NCT03458169

LEAP a New Overground Body Weight Support Robot: Usability 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.

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Key information

Conditions

Spinal Cord Injuries Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders People With Impaired Lower Extremity Function Spinal Cord Diseases Stroke Synucleinopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Romande de Réadaptation (CRR), SUVAcare

Sion, Valais, 1951, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapist LEAP session feedback

Device

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.

Participant LEAP session feedback

Device

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.

LEAP risk control validation

Device

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 outcomes

  1. 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. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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.

  7. 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.

  8. 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)

  9. 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)

  10. 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)

Secondary outcomes

  1. Robot Measurement - Patient position

    Time frame: 1 hour

    The robot records the patient position in the room (in meters).

  2. Robot Measurement - Walking speed

    Time frame: 1 hour

    The robot records the walking speed (in meters per second).

  3. Robot Measurement - Occurred errors

    Time frame: 1 hour

    The robot records the errors occurred (error number).

  4. Robot Measurement - Support forces

    Time frame: 1 hour

    The robot records the support forces (in Newton).

  5. Robot Measurement - Fall detection

    Time frame: 1 hour

    The robot records the number of detected falls (Amount of detected falls).

  6. Robot Measurement - Walked distance

    Time frame: 1 hour

    The robot records the distance the patient walked during the session (in meters).

  7. EMG system

    Time frame: 1 hour

    Upon availability, an EMG system will be used to measure muscle activity during the session.

  8. Patient characteristics - Testing date

    Time frame: 1 minutes

    The testing date (day/month/year) is being recorded.

  9. Patient characteristics - Identification number

    Time frame: 1 minutes

    A unique participant identification number is being recorded.

  10. Patient characteristics - Body height

    Time frame: 1 minutes

    The body height (in cm) is being recorded.

  11. Patient characteristics - Body weight

    Time frame: 1 minutes

    The body weight (in kg) is being recorded.

  12. Patient characteristics - Waist size

    Time frame: 1 minutes

    The waist size (in cm) is being recorded.

  13. Patient characteristics - Tight circumference

    Time frame: 1 minutes

    The tight circumference (in cm) is being recorded.

  14. Patient characteristics - Chest size

    Time frame: 1 minutes

    The chest size (in cm) is being recorded.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.).

  20. 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).

  21. 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).

Sponsors and collaborators

Lead sponsor

Clinique Romande de Readaptation

Network

Registry information

Official study title

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

Acronym: LEAP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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