LEAP a New Overground Body Weight Support Robot: Usability Trial
Usability of a New Overground Body Weight Support Rehabilitation Robot LEAP: A Monocentric Consideration-of-concept Trial
What it found
We found no results in the registry or in papers.
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Therapist LEAP session feedback
- Participant LEAP session feedback
- LEAP risk control validation
What it measured
Main measures
Usability of the robot - Fixation
2 minutes
Usability of the robot - Applicability
2 minutes
Usability of the robot - Robot support
2 minutes
Usability of the robot - User interface
2 minutes
Usability of the robot - Interaction
2 minutes
Risk control validation - Observer
1 hour
Risk control validation - User
1 hour
Participant feeling of safety/comfort - Fixation
1 minute
SafetyParticipant feeling of safety/comfort - Robot training
1 minute
SafetyParticipant feeling of safety/comfort - Robot support
1 minute
Safety
Other measures (21)
Robot Measurement - Patient position
1 hour
Robot Measurement - Walking speed
1 hour
Walking and mobilityRobot Measurement - Occurred errors
1 hour
Robot Measurement - Support forces
1 hour
Robot Measurement - Fall detection
1 hour
Walking and mobilityRobot Measurement - Walked distance
1 hour
Walking and mobilityEMG system
1 hour
Patient characteristics - Testing date
1 minutes
Patient characteristics - Identification number
1 minutes
Patient characteristics - Body height
1 minutes
Who could take part
MS (type not specified) · 5 to 80
Show the full criteria
Inclusion 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Freund P, Weiskopf N, Ward NS, Hutton C, Gall A, Ciccarelli O, Craggs M, Friston K, Thompson AJ. Disability, atrophy and cortical reorganization following spinal cord injury. Brain. 2011 Jun;134(Pt 6):1610-22. doi: 10.1093/brain/awr093. Epub 2011 May 17.Background
Kennedy P, Rogers BA. Anxiety and depression after spinal cord injury: a longitudinal analysis. Arch Phys Med Rehabil. 2000 Jul;81(7):932-7. doi: 10.1053/apmr.2000.5580.Background
Fehr L, Langbein WE, Skaar SB. Adequacy of power wheelchair control interfaces for persons with severe disabilities: a clinical survey. J Rehabil Res Dev. 2000 May-Jun;37(3):353-60.Background
Hunt PC, Boninger ML, Cooper RA, Zafonte RD, Fitzgerald SG, Schmeler MR. Demographic and socioeconomic factors associated with disparity in wheelchair customizability among people with traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1859-64. doi: 10.1016/j.apmr.2004.07.347.Background
Meyns P, Van de Crommert HW, Rijken H, van Kuppevelt DH, Duysens J. Locomotor training with body weight support in SCI: EMG improvement is more optimally expressed at a low testing speed. Spinal Cord. 2014 Dec;52(12):887-93. doi: 10.1038/sc.2014.172. Epub 2014 Oct 14.Background
Crompton S, Khemlani M, Batty J, Ada L, Dean C, Katrak P. Practical issues in retraining walking in severely disabled patients using treadmill and harness support systems. Aust J Physiother. 2001;47(3):211-3. doi: 10.1016/s0004-9514(14)60268-3. No abstract available.Background
Wessels M, Lucas C, Eriks I, de Groot S. Body weight-supported gait training for restoration of walking in people with an incomplete spinal cord injury: a systematic review. J Rehabil Med. 2010 Jun;42(6):513-9. doi: 10.2340/16501977-0525.Background
Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-3Background
Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.Background
Hoyer E, Jahnsen R, Stanghelle JK, Strand LI. Body weight supported treadmill training versus traditional training in patients dependent on walking assistance after stroke: a randomized controlled trial. Disabil Rehabil. 2012;34(3):210-9. doi: 10.3109/09638288.2011.593681.
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History
Started
Jan 2018
Main results due
Apr 2018
Finished
Apr 2018