Influence of supportive forces on daily activities
Résumé de l'étude
This study is a cross-sectional study examining the influence of the supportive forces of the therapeutic robot FLOAT on the execution of daily activities. The study takes place at the Balgrist University Hospital in Zurich over a period of about 3 years. Measurements will be conducted on approximately 120 healthy subjects and 20 patients with an incomplete spinal cord injury. Study participants will be invited for a visit lasting about 140 minutes at the Balgrist University Hospital. During the visit, participants will repeatedly perform different daily activities (free walking, standing/sitting, stair climbing, and balancing) with and without supportive forces provided by the FLOAT. Their movements and muscle activities will be measured, allowing us to make statements about the naturalness of the movements. The collected data will also allow us to compare different movement patterns and draw conclusions about optimal support. This will enable future therapy of these daily movements to be specifically tailored to the patients and to train the movements with the help of the FLOAT under optimal conditions.
(BASEC)
Intervention étudiée
- Device: The cable robot FLOAT is a novel weight relief system that allows users to move freely in space. Users are connected to the robot via a harness. This allows the robot to exert three-dimensional forces on the users. The generated forces can be used to facilitate or disrupt a user's movements. Additionally, the FLOAT functions as a safety mechanism that detects and cushions any falls. The FLOAT can be used extremely versatile and its unique design allows therapies that have not been trainable with other robotic devices until now. - Application: This study will investigate how study participants manage various daily movements such as standing/sitting or stair climbing with and without the help of supportive forces from the therapeutic robot FLOAT. To this end, subjects will perform these daily movements and will be supported by forces of varying strengths and orientations.
(BASEC)
Maladie en cours d'investigation
Neurologically induced gait disorders in patients with an incomplete spinal cord injury (classified as AIS C-D according to the ASIA Impairment Scale)
(BASEC)
- Patients with incomplete spinal cord injury (AIS C-D) - Healthy volunteers without gait disorders - older than 18 years (BASEC)
Critères d'exclusion
- Notable psychiatric or orthopedic (disorder of the human Musculoskeletal system) diagnosis - Notable secondary (in addition to spinal cord injury) neurological disorders - contraindications (circumstances that are against use of a Treatment / application talk) for FLOAT training (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Spinal Cord Injury Centre, University Hospital Balgrist Forchstrasse 340, CH-8008 Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Marc Bolliger
Tel. +41 44 510 72 01
marc.bolliger@clutterbalgrist.chUniversity of Zurich Spinal Cord Injury Center, Research Balgrist University Hospital Forchstrasse 340, 8008 Zurich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
14.12.2016
(BASEC)
Identifiant de l'essai ICTRP
NCT03004144 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Impact of robotic assistive forces on the performance of activities of daily living (BASEC)
Titre académique
Impact of Robotic Assistive Forces on the Performance of Activities of Daily Living (ICTRP)
Titre public
Impact of Assistive Forces on Activities of Daily Living (ICTRP)
Maladie en cours d'investigation
Spinal Cord Injury (ICTRP)
Intervention étudiée
Other: FLOAT (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons
- informed consent as documented by signature
- bodyweight < 120 kg
Exclusion Criteria:
- a significant psychiatric or orthopedic diagnose
- any secondary neurological complications that may impact the outcome variables
- dermatological conditions (pressure ulcers, etc.)
- pacemaker or other implanted, electronic devices
- contraindications for FLOAT training
- inability or unwillingness to provide written informed consent or follow study
procedures e.g. due to language problems
- psychological disorders, dementia, etc.
- known or suspected non-compliance, drug or alcohol abuse
- enrolment of the investigator, his/her family members, employees and other dependent
persons (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks (ICTRP)
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
2016-01093 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03004144 (ICTRP)
Résultats de l'essai
Résumé des résultats
2016-01093-studieenbericht.pdfLien vers les résultats dans le registre primaire
non disponible