UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055273 |
|---|---|
| Receipt number | R000063153 |
| Scientific Title | Development of a Remote Rehabilitation System to Enhance Physical Activity in Patient with Neurodegenerative Diseases |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/10/25 16:38:34 |
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Basic information
Public title
Development of a Remote Rehabilitation System to Enhance Physical Activity in Patient with Neurodegenerative Diseases
Acronym
Remote Rehab Research for Neurodegenerative Diseases
Scientific Title
Development of a Remote Rehabilitation System to Enhance Physical Activity in Patient with Neurodegenerative Diseases
Scientific Title:Acronym
Remote Rehab Research for Neurodegenerative Diseases
Region
| Japan |
Condition
Condition
Patients with neurodegenerative disease (especially, Parkinson's disease and dementia), and those in the prodromal phase of the disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility and safety of a telerehabilitation system for patients with neurodegenerative diseases. As a preliminary evaluation, the effects on physical activity and brain networks will be examined as indicators of motivation for rehabilitation and changes in social behaviour.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective satisfaction scale
Key secondary outcomes
All adverse events. System Usability Scale (SUS), exercise adherence (number of participants achieving acceptable adherence (>60%) and ideal adherence (>80%)), daily physical activity (physical activity, moderate- and high-intensity physical activity), balance and gait assessment (10 m - walking speed, Mini- BESTest, 3m-TUG test), change in upper limb function assessment (box and block test), change in motor features of Parkinson's disease (MDS-UPDRS, FOGQ), change in quality of life assessment (WHO-QOL, PDQ8), and change in functional/ structural MRI at the 2-month and 4-month visits compared with baseline.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
2 months of voluntary exercise training and guidance using a remote rehabilitation system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have given written consent to participate in the research
2. 40 years of age or older
3a. For patients with Parkinson's disease, those diagnosed with probable PD or clinically established PD according to MDS criteria and HY stage 2-4 at the time of enrolment.
3b. For patients with mild dementia, those with MMSE less than 26 and greater than 17 and independent in activities of daily living except bathing. Background disease will be classified according to the revised NIA/AA diagnostic criteria (Alzheimer's disease) and the clinical diagnostic criteria for the prodromal DLB study (dementia with Lewy bodies), and those who are difficult to classify according to both will be classified as MCI unclassifiable (MCI-Dz).
3c. For patients with Parkinson's disease and dementia in the prodromal phase, those who meet some of the diagnostic biomarkers and diagnostic criteria for each disease listed above and are expected to develop the disease in the future.
4. Patients who have the cooperation of a caregiver
5. Patients who are able to walk a stable 10m with the use of assistive devices such as prostheses and walking sticks.
6. Patients who have been taking a fixed dose of antiparkinsonian or antidementia medication for at least two months prior to enrolment
7. Patients who be able to understand verbal instructions and perform tasks adequately
Key exclusion criteria
1. Patients with severe cognitive impairment (<16 points on MMSE)
2. Patients with unstable general condition, including vital signs
3. Patients with severe visual impairment (corrected binocular vision below 0.05).
4. Patients who are pregnant, lactating or may become pregnant.
5. Patients with pre-existing or concomitant clinically relevant neuropsychiatric disorders (e.g. patients requiring adjustment of antipsychotic medication)
6. Patients who have participated in other motor function intervention studies within 6 months prior to enrolment
7. Patients who are difficult to assess at each visit due to unpredictable wearing-off or On-off symptom.
8. Patients with osteoarticular complications such as lumbar spinal stenosis or back pain that affect motor assessment
9. Patients who are deemed by the investigator to be unsuitable for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mihara |
| Middle name | |
| Last name | Masahito |
Organization
Kawasaki Medical School Hospital
Division name
Department of neurology
Zip code
7010192
Address
577 Matsushima, Kurashiki, Okayama
TEL
0864621111
neuro-office@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Mihara |
| Middle name | |
| Last name | Masahito |
Organization
Kawasaki Medical School Hospital
Division name
Department of neurology
Zip code
7010192
Address
577 Matsushima, Kurashiki, Okayama
TEL
0864621111
Homepage URL
neuro-office@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Mihara Masahito
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Clinical Research Review Committee
Address
577, Matsushima, Kurashiki, Okayama
Tel
086-464-1076
kmsrec@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063153
