UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054301 |
|---|---|
| Receipt number | R000062022 |
| Scientific Title | Development of a Tele-rehabilitation System to Increase Physical Activity in Seniors Residents in the Community |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/08/18 11:46:24 |
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Basic information
Public title
Development of a Tele-rehabilitation System to Increase Physical Activity in Seniors Residents in the Community
Acronym
Tele-PAS study
Scientific Title
Development of a Tele-rehabilitation System to Increase Physical Activity in Seniors Residents in the Community
Scientific Title:Acronym
Tele-PAS study
Region
| Japan |
Condition
Condition
Neurodegenerative diseases (e.g. Parkinson's disease, Dementia)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For maintaining and promoting the health of the seniors, regular exercise practice and its habituation are important. Particularly for patients with neurodegenerative diseases living in the community, there are numerous challenges such as a lack of instructors, insufficient medical resources, and difficulty in accessing specialist clinics. Recently, the effectiveness of rehabilitation using mobile health devices and communication technology (tele-rehabilitation; Tele-Reha) has been reported extensively. However, since previous Tele-Reha requireed face-to-face instruction, the human and time constraints on medical practitioners have not been resolved, and it has never been used on a large scale in clinical practice before. Therefore, we have developed a Tele-Reha system that minimizes the burden on both patients and medical practitioners. This system is based on activity assessment through mobile health devices, and video-assisted self-training. The purpose of this study is to evaluate the safety and feasibility of the Tele-Reha system for senior patients with neurological diseases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Customer Satisfaction Index (CSI)
Key secondary outcomes
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).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 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.
Key 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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Mihara |
Organization
Kawasaki Medical School
Division name
Neurology
Zip code
7010192
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
neuro-office@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kajiyama |
Organization
Kawasaki Medical School
Division name
Neurology
Zip code
7010192
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
y.kajiyama@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Yuta Kajiyama
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
kenkyuhou2@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 | 07 | 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
0
Results
Study withdrawn due to reconsideration of research plan.
Results date posted
| 2024 | Year | 08 | Month | 18 | Day |
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
Terminated
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the tele-rehabilitation training consists of monthly outpatient visits (1 month visit: V1, 2 months visit: V2) and video-guided self-training using an mHealth device. Patients are provided with an mHealth device and a training menu tailored to their motor function. Patients use the app to select and play the self-training videos and do at least one set (about 30 minutes) every day. As a means of monitoring, the types and frequencies of the videos played are stored on the mHealth device. At V1, the training menu is readjusted based on the achievement of the training, and participants continue their self-training using the new training menu. In addition to outpatient visits, patients receive feedback on their training by telephone or email about once a week, where problems are identified and they are encouraged to actively engage in self-training.
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062022
