Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments
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|ClinicalTrials.gov Identifier: NCT03268304|
Recruitment Status : Withdrawn (The software modules were not completed.)
First Posted : August 31, 2017
Last Update Posted : April 21, 2020
Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process.
Objectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients & methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L).
Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training.
|Condition or disease||Intervention/treatment|
|Stroke Parkinson Disease Traumatic Brain Injury Guillain-Barre Syndrome||Other: VR-based training including AO and MI|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||May 30, 2020|
- Other: VR-based training including AO and MI
Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device
- cARAT [ Time Frame: 17 weeks ]Score on the conventional Action Research Arm Test
- dARAT [ Time Frame: 17 weeks ]score on the digital ARAT
- SUS [ Time Frame: 15 weeks ]System Usability Scale questionnaire
- BBT [ Time Frame: 17 weeks ]Box and Block Test
- CAHAI [ Time Frame: 17 weeks ]Chedoke McMaster Arm and Hand Activity Inventory
- EQ-5D-5L [ Time Frame: 17 weeks ]EuroQol five dimensions questionnaire with five-level scale
- PGIC [ Time Frame: 11 weeks ]Patient Global Impression of change
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268304
|Principal Investigator:||Frank Behrendt, PhD||Reha Rheinfelden|
|Principal Investigator:||Corina Schuster, PhD||Reha Rheinfelden|