Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments

Sponsor

Reha Rheinfelden (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03268304

Collaborator

(none)

Enrollment

18.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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	Phase
Stroke Parkinson Disease Traumatic Brain Injury Guillain-Barre Syndrome	Other: VR-based training including AO and MI

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Nov 1, 2018

Actual Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

May 30, 2020

Outcome Measures

Primary Outcome Measures

cARAT [17 weeks]
Score on the conventional Action Research Arm Test
dARAT [17 weeks]
score on the digital ARAT
SUS [15 weeks]
System Usability Scale questionnaire

Secondary Outcome Measures

BBT [17 weeks]
Box and Block Test
CAHAI [17 weeks]
Chedoke McMaster Arm and Hand Activity Inventory
EQ-5D-5L [17 weeks]
EuroQol five dimensions questionnaire with five-level scale
PGIC [11 weeks]
Patient Global Impression of change

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with motor function impairments of one or both upper limbs caused by Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome
Able to sit in a normal chair without armrests
Able to score at least one in the Box and Block Test (BBT)
Comprehend German
Informed Consent as documented by signature

Exclusion Criteria:

Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture
Severe cognitive deficits: Mini-Mental-Status-Test (MMSE) ≤ 20
Severe spatial-visual disorders, e.g. severe visual neglect
History of epileptic seizures triggered by visual stimuli (e.g. television, video games) within the last six months
Enrolment of the investigator, his/her family members, employees and other dependent persons
Full score in the Chedoke Arm and Hand Activity Inventory (CAHAI) assessment
Brain pacemaker