Neurodegenerative diseases (e.g. Parkinson'
Conditions
Interventions
None listed
Sponsors
Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given written consent to participate in the study. 2. 40 years of age or older. 3a. Patients with Parkinson's disease (PD) diagnosed as probable PD or clinically established PD according to MDS criteria, and HY stage 2 to 4 at the time of enrolment. 3b. Patients with mild cognitive impairment, MMSE score between 17 and less than 26, independent in activities of daily living except bathing. Background diseases classified according to the revised NIA/AA diagnostic criteria (Alzheimer's disease) and clinical diagnostic criteria for prodromal DLB (dementia with Lewy bodies), with those difficult to classify in either category being labelled as unclassifiable MCI (MCI-Dz). 3c. Prodromal Parkinson's disease and dementia patients, those who meet some of the diagnostic biomarkers and criteria for each disease and are expected to develop the disease in the future. 4. Patients who have the cooperation of a cohabiting caregiver. 5. Patients who are able to walk a stable 10 metres with the aid of orthotics, canes or other assistive devices. 6. Patients who have been on a stable dose of anti-Parkinson's or anti-dementia medication for at least two months prior to enrolment. 7. Patients who can understand verbal instructions and perform tasks adequately.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cognitive impairment (score of 16 or less on the MMSE). 2. Patients whose general condition, including vital signs, is unstable. 3. Individuals with severe visual impairment (corrected binocular visual acuity of 0.05 or less). 4. Females who are pregnant, lactating, or may become pregnant. 5. Patients with a history of or concurrent clinically significant psychiatric or neurological disorders (such as those requiring adjustment of antipsychotic medication). 6. Patients who have participated in other motor function intervention studies within the last 6 months prior to enrolment. 7. Patients for whom assessment during the 'ON' phase is difficult at each visit due to unpredictable wear-off/on-off effects. 8. Patients with musculoskeletal complications such as lumbar spinal stenosis and back pain that may interfere with exercise assessment. 9. Patients who are considered by the physician to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Customer Satisfaction Index (CSI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events. System Usability Scale (SUS). Adherence to self-training (number of participants who achieved acceptable adherence rate (60% or higher) and ideal adherence rate (80% or higher)). Changes in activity level (daily physical activity, daily moderate to vigorous physical activity (MVPA)). Changes in balance and gait assessment (10m walking speed, Mini-BESTest, 3m-TUG test). Changes in upper limb function assessment (Box & Block Test). Changes in Parkinson's disease assessment scales (MDS-UPDRS, FOGQ). Changes in Quality of Life assessments (WHO-QOL, PDQ8). Functional/structural MRI (only for evaluable patients). | — |
Countries
Japan
Contacts
Public ContactYuta Kajiyama
Kawasaki Medical School Neurology
Outcome results
None listed