pper limb training with virtual reality in patients with Parkinson's disease: a randomised controlled trial
- Conditions
- Parkinson diseaseG20
- Registration Number
- DRKS00034193
- Lead Sponsor
- CUREosity GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
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 State Examination 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.
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Arm function, assessed at baseline and 4-week post-intervention by blinded assessors using the Action Research Arm Test<br>2. Hand function, assessed at baseline and 4-week post-intervention by blinded assessors using the Jebsen Taylor Hand Function Test
- Secondary Outcome Measures
Name Time Method