G20
Conditions
Interventions
Group 1: Intervention group 1 will receive 16 units of 30 minutes each of specific VR-based upper extremity training over a period of 4 weeks, which will be carried out in a 1:1 setting by trained occ
Sponsors
CUREosity GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with Parkinson's disease according to the Parkinson's Disease Society Brain Bank criteria, aged =18 years; male, female or diverse gender; Hoehn and Yahr stage I-IV, with impaired function of one or both upper extremities (evaluated by a neurologist), with adequate cognitive function (Mini Mental Status Test Score =24/30), which are clinically stable and constant dose of dopaminergic therapy received, and with written consent after medical and therapeutic information. Patients will be included in the study if they have an inpatient neurological rehabilitation stay at Clinic for Rehabilitation Münster, Tyrol or at Klinikum Bad Hall & Bad Schallerbach, location Bad Hall during the study period.
Exclusion criteria
Exclusion criteria: Patients with diagnosed pronounced vertigo associated with possible motion/cyber sickness, other neurological, psychiatric or severe orthopaedic/rheumatological diseases, malignant diseases or any other impaired health condition that could affect the intervention or testing are excluded. Also excluded are patients with recent surgical interventions on the joints or soft tissues of the upper extremities or cervical spine, pronounced arthrosis or inflammatory diseases of the upper extremity as well as untreated visual or hearing disorders and pregnancy according to pregnancy test in women of childbearing age prior to enrolment in the clinical trial. In the event of a change in medication that may influence the results (especially dopaminergic medication), patients may be excluded from the study at the discretion of the investigators. Any change of medication will be documented in the study protocol. At the discretion of the investigator, patients with - a fracture tendency or existing fractures, e.g. severe osteoporosis or osteomalacia, neoplastic, pathological, or traumatic genesis - uncontrollable disturbance of vital functions, e.g. pulmonary and/or cardiovascular diseases (instability, drug, or instrumental support for these functions) - acute exacerbation of Parkinson's disease - intravenous access in the upper extremities with ongoing infusion - shoulder joint (sub)dislocation or unacceptable pain in the shoulder joint - uncontrollable epilepsy and seizures - uncorrectable severe visual impairment that precludes the use of an HMD (head-mounted display) (e.g. complete blindness) - pronounced hypacusis or lack of the necessary aids to compensate for this - uncontrollable vestibular disease - acute migraine attack - lack of adaptability of the VR headset to the head size - insufficient/insufficient strength of the neck muscles to wear the VR headset
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Arm function, assessed at baseline and 4-week post-intervention by blinded assessors using the Action Research Arm Test 2. Hand function, assessed at baseline and 4-week post-intervention by blinded assessors using the Jebsen Taylor Hand Function Test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Gross motor hand function, assessed at baseline and 4-week post-intervention by blinded assessors using the Box and Blocks Test 2) Fine motor hand function, assessed at baseline and 4-week post-intervention by blinded assessors using the Nine Hole Peg Test 3) Finger coordination, assessed at baseline and 4-week post-intervention by blinded assessors using the Finger Tapping Test 4) Disease severity, assessed at baseline and 4-week post-intervention by blinded assessors using the Hoehn und Yahr Scale and Unified Parkinson’s Disease Rating Scale II & III 5) Intrinsic motivation, assessed at baseline and 4-week post-intervention by blinded assessors using the Short Scale of Intrinsic Motivation 6) Health-related quality of life, assessed at baseline and 4-week post-intervention by blinded assessors using the Parkinson’s Disease Questionnaire-39 7) Training adherence, assessed throughout the 4-week intervention period by treating physiotherapists and/or occupational therapists using the number of intervention sessions actually carried out; in addition, the ratio of actual/planned intervention sessions will be calculated 8) Intervention acceptability, assessed at 4-week post-intervention by blinded assessors using the Smiley Likert Scale 9) Usability of the CUREO® VR-Therapy System, assessed at 4-week post-intervention by blinded assessors using the System Usability Scale During the entire study period, adverse events / side effects will be recorded using a structured procedure. | — |
Countries
Austria
Contacts
Public ContactKlaus Heinzle
Klinikum Bad Hall & Bad Schallerbach, Standort Bad Hall
Outcome results
None listed