G20
Conditions
Interventions
Group 1: Intervention group
Rolling over the longitudinal axis of the body is performed as an additional intervention to conventional, multidisciplinary rehabilitation for 15 minutes, five times a wee
a total of three rounds should be performed, resulting in a total duration of 15 minutes.
Afterwards, acceptance is assessed using three predefined questions on a five-point Likert scale and well-bei
Sponsors
Klinikum Bad Hall & Bad Schallerbach, Standort Bad Hall
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Stage 1 to 4 according to Hoehn & Yahr with ON medication (Hoehn and Yahr, 1967) - Age =18 years - Any ethnicity - Mini-Mental Status Test (MMST) score =24 out of 30 - Stable dosage of dopaminergic replacement therapy at least 3 weeks before the start of the study or still without dopaminergic treatment for the duration of the study intervention - German spoken and written
Exclusion criteria
Exclusion criteria: - Concomitant disease(s) (such as malignant diseases, other neurological, serious orthopaedic, cardiac, or psychiatric diseases, major depression, dementia) - Orthostatic hypotension - Non-Parkinsonian gait disorder (e.g. due to musculoskeletal symptoms) - Recent surgical intervention - uncorrected visual or hearing impairment that would interfere with training or assessments - joint replacement therapies within the last six months - Spinal surgery within the last twelve months - Pregnancy, verified by a pregnancy test - Pronounced degenerative spinal diseases (stiffening) - Recent deep brain stimulation (DBS) or change in DBS parameters within the last year - Severe motor fluctuations Initiation of a new dopaminergic medication or adjustment of the same within the study period is not planned; in the sense of a real-life setting, this decision is the responsibility of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Static and dynamic balance, assessed using the Berg Balance Scale (BBS) at baseline and 3-week post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Feasibility of a larger randomised controlled trial, evaluated on the basis of predefined feasibility criteria: Suitability rate, recruitment rate, retention rate, adherence rate, acceptance of the intervention and safety (in terms of serious adverse events causally related to the study intervention) -The target eligibility rate is 60% of patients with idiopathic Parkinson's syndrome admitted to the Bad Hall Clinic for inpatient neurological rehabilitation during the study period. -The target recruitment rate is 40% of patients eligible according to the inclusion and exclusion criteria of this study (or at least 3-4 participants per month). -The target retention rate is 80% of the patients included in the study. -The target adherence rate is 80% of the planned interventions, i.e. at least twelve interventions during the study period. -Acceptability of the intervention in the intervention group is assessed using three predefined questions and a five-point Likert scale (from 1 = very good to 5 = not good at all). This scale can be found in the CRF. -The aim with regard to the safety of the intervention is to ensure that no serious adverse events (AEs) causally related to the study intervention occur. This includes, in particular, falls resulting in injury. 2) Walking speed, assessed using the 10-Metre Walk Test at baseline and 3-weeks post-intervention. 3) Postural stability during walking, assessed using the Functional Gait Assessment (FGA) at baseline and 3-weeks post-intervention. 4) Functional mobility, assessed using the Timed Up and Go (TUG) at baseline and 3-weeks post-intervention. 5) Concerns about falling, assessed using the Falls Efficacy Scale-International (FES-I) at baseline and 3-weeks post-intervention. 6) Well-being during the intervention, assessed using the 10-point Visual Analogue Scale after each intervention | — |
Countries
Austria
Contacts
Public ContactTarek Elsherif
Klinikum Bad Hall & Bad Schallerbach, Standort Bad Hall
Outcome results
None listed