Secondary study: No health problem
Conditions
Interventions
Group 1: Activity oriented physiotherapy exercise programme combined with an eye movement training: 30 min, 4x per week, supervised by trained physiotherapists. A total of 16 30-minute training sessio
Sponsors
Karl Landsteiner Institut für interdisziplinäre Rehabilitationsforschung, Reha Zentrum Münster
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: Males and females with idiopathic Parkinson’s syndrome according to the UK Brain Bank criteria (Hughes et al., 1992), Hoehn & Yahr stage 1-3 with ON medication (Hoehn and Yahr, 1967), age 30-80 years, any ethnicity, ability to walk without assistance, Mini-Mental-Status-Test (MMST) = 24/30 (Tombaugh and McIntyre, 1992), stable dose of dopaminergic therapy for a minimum of 3 weeks prior to study entry or being without dopaminergic therapy for the study duration, German speaking and writing. Secondary study: Experts from the professional groups of physicians, therapy managers and physiotherapists with a recognised professional qualification, fluent in the German language.
Exclusion criteria
Exclusion criteria: Concomitant diseases (e.g., malignant diseases, other neurological, orthopaedic, cardial or psychiatric disorders, major depression, dementia), photosensitivity, non-parkinsonistic gait disorder (e.g., due to musculoskeletal symptoms), recent surgery (general and eye surgery), intraocular implants, strabismus, nystagmus, severe drooping eyelids, untreated pain, uncorrected visual or hearing impairment, which may be a barrier to the training or assessments, pregnancy, recent deep brain stimulation (DBS) or a change in DBS parameters within the previous year, severe motor fluctuations, initiation of a new dopaminergic medication or adjustment thereof within the study period is not planned; as this is a study in a real-life setting the principle investigator may decide whether an adjustment is necessary however.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.1 Dynamic balance as assessed with the Functional Gait Assessment (FGA) 1.2 FGA Items 5, 6 und 10 will be performed using a mobile eye tracker (Tobii Pro Glasses 3) to assess eye movements (saccades velocity, -amplitude, -time to fixation, fixation duration) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2.0 Screening for cognitive function or impairment: Mini-Mental State Test (MMST) 2.1 Functional mobility as assessed with the Timed-Up-and-Go (TUG) 2.2 Functional mobility with dual-tasking as assessed with the Manual Timed-Up-and-Go (TUGman) 2.3 Static and dynamic balance as assessed with the Berg Balance Scale (BBS) 2.4 Dynamic balance as assessed by the des Four-Square Step Test (FSST) 2.5 Walking speed as assessed by the 10-Metre Walk Test (10MWT) 2.6 Health-related quality of life as assessed with the Parkinson’s Disease Questionnaire-39 (PDQ-39) 2.7 Freezing of Gait as assessed with the Freezing of Gait Questionnaire (FOGQ) 2.8 Fall-associated self-efficacy as assessed with the Falls Efficacy Scale- Internationale Version (FES-I) 2.9 Depression as assessed with the Beck Depression Inventory (BDI-II) 2.10 Fall rate within the last 3 months prior to study enrolment, during the 4-week intervention period and the 4-week follow-up period 2.11 Mobile assessment of eye movements (saccades velocity, -amplitude, -time to fixation, fixation duration) during the intervention (once a week i.e., at the last training session per week, for 12 min, during exercises 2, 3, 4, 6, and 7) 2.12 Feasibility of a larger randomised controlled study (recruitment-, retention-, adherence rates, adverse events, acceptability of the intervention (only in the intervention group) as evaluated with focus groups in participants of the intervention group at post-intervention Secondary study: Barriers to and facilitators for the implementation of RCT in a real-life setting from the perspectives of representatives of three professional groups. | — |
Countries
Austria, Germany
Contacts
Public ContactBarbara Seebacher
Reha Zentrum Münster
Outcome results
None listed