Comparison of two balance training programmes on postural control in people with Parkinson’s disease

Not Applicable

Recruiting

Conditions: G20
Parkinson disease

Registration Number: DRKS00029750

Lead Sponsor: Freiraum Physiotherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Males and females with idiopathic Parkinson’s Disease based on the UK Brain Bank criteria (Hughes et al., 1992), Stage 2.5-4.0 on the Hoehn & Yahr scale, ON Medication (Hoehn and Yahr, 1967), age 18-999 years, any ethnicity, Mini-Mental-Status-Examination (MMSE) =24/30 (Tombaugh and McIntyre, 1992) stable dosage of dopaminergic replacement therapy min. 3 weeks before the start of the study or without dopaminergic treatment for the duration of the study intervention, fluent in spoken and written German language.

Exclusion Criteria

Concomitant disease(s) (such as malignant diseases, other neurological, orthopaedic, cardiac or psychiatric diseases, major depression, dementia), non-Parkinson’s walking impairment (e.g., due to musculoskeletal symptoms), recent surgical intervention, untreated pain, uncorrected visual or auditory impairment, which would affect training or testing, pregnancy, recent deep brain stimulation (DBS) or change in DBS parameters within the last year, severe motor fluctuations, initiation of a new dopaminergic medication or adaptation thereof within the study period is not foreseen; in the sense of a real-life setting, this decision is the responsibility of the investigator.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postural control as measured by the Mini - Balance Evaluation Systems Test (BESTest), which also includes the Timed Up & Go with Dual Task

Secondary Outcome Measures

Name	Time	Method
1. Fall-related self-efficacy measured by Falls Efficacy Scale (FES-I)<br>2. Fall rate, based on the number of falls within 12 weeks before study inclusion, within the active phase (intervention) of the study and in the 12-week follow-up period<br>3. Walking speed, measured by the 10-Meter Walk Test (10MWT)<br>4. Walking distance, measured by the 6-Minute Walk Test (6MWT<br>5. Mobility as measured by the Timed Up and Go (TUG) test<br>6. Dynamic balance, measured using the Functional Reach Test (FRT)<br>7. Health-related quality of life, measured using the Parkinson’s Disease Questionnaire-39 (PDQ-39)<br>8. Feasibility of a larger randomised parallel study based on recruitment rate, retention rate, adherence rate and high safety due to absence of or low/mild adverse events/side effects<br>