- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03268304
Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Patients will be recruited from the clinics' inpatient or outpatient departments by physicians, therapists and nurses.
- Patients will be recruited from the clinics' patient database. Datasets will be screened for study selection criteria by the involved study personnel. If patients are eligible, they will be sent a letter describing the study and including patient information. If patients are interested in participating, they can contact the study personnel in the clinic by phone or email.
- Patients will be recruited via a study information flyer provided on the clinic's homepage and through patient self-help groups. If patients are interested in participating, they can contact the study personnel in the responsible clinic by phone or email.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cARAT
Time Frame: 17 weeks
|
Score on the conventional Action Research Arm Test
|
17 weeks
|
dARAT
Time Frame: 17 weeks
|
score on the digital ARAT
|
17 weeks
|
SUS
Time Frame: 15 weeks
|
System Usability Scale questionnaire
|
15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BBT
Time Frame: 17 weeks
|
Box and Block Test
|
17 weeks
|
CAHAI
Time Frame: 17 weeks
|
Chedoke McMaster Arm and Hand Activity Inventory
|
17 weeks
|
EQ-5D-5L
Time Frame: 17 weeks
|
EuroQol five dimensions questionnaire with five-level scale
|
17 weeks
|
PGIC
Time Frame: 11 weeks
|
Patient Global Impression of change
|
11 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Behrendt, PhD, Reha Rheinfelden
- Principal Investigator: Corina Schuster, PhD, Reha Rheinfelden
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Peripheral Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Polyradiculoneuropathy
- Polyneuropathies
- Parkinson Disease
- Brain Injuries
- Brain Injuries, Traumatic
- Guillain-Barre Syndrome
Other Study ID Numbers
- KAYO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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