LEAP a New Overground Body Weight Support Robot: Usability Trial

NCT03458169 | Completed

• 1 other identifier: CliniqueRR-05
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Cerebral Palsy; Parkinson Disease; Multiple Sclerosis; Stroke; People With Impaired Lower Extremity Function

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (21)

• Robot Measurement - Patient position

  1 hour

• Robot Measurement - Walking speed

  1 hour

• Robot Measurement - Occurred errors

  1 hour

• Robot Measurement - Support forces

  1 hour

• Robot Measurement - Fall detection

  1 hour

Study Arms (1)

LEAP usability

EXPERIMENTAL

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

Device: Therapist LEAP session feedback; Device: Participant LEAP session feedback; Device: LEAP risk control validation

Interventions

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.

LEAP usability

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 usability

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.

LEAP usability

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Romande de Readaptation: lead

Study Sites (1)

Clinique Romande de Réadaptation (CRR), SUVAcare

Sion, Valais, 1951, Switzerland

Location

Related Publications (40)

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MeSH Terms

Conditions

Spinal Cord Injuries; Cerebral Palsy; Parkinson Disease; Multiple Sclerosis; Stroke

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Brain Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Urs Keller, PhD

  Ecole Polytechnique Fédérale de Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: March 8, 2018
• Study Start: January 1, 2018
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: January 30, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)