UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058956 |
|---|---|
| Receipt number | R000067239 |
| Scientific Title | Evaluation of a Long-term Care Prevention Program Using a Cybernic System (Wearable Cyborg HAL) in Community-dwelling Older Adults: A Pre-Post Study |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/02 10:22:15 |
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Basic information
Public title
A Community-based Long-term Care Prevention Program Using a Cybernic System: A Pre-Post Study with the Wearable Cyborg HAL
Acronym
HAL Care and Frailty Prevention
Scientific Title
Evaluation of a Long-term Care Prevention Program Using a Cybernic System (Wearable Cyborg HAL) in Community-dwelling Older Adults: A Pre-Post Study
Scientific Title:Acronym
HAL-CPF
Region
| Japan |
Condition
Condition
Community-dwelling independent older adults (independent in daily life, with or without chronic lifestyle-related diseases), older adults eligible for long-term care prevention programs, and older adults with pre-frailty
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of a long-term care and frailty prevention program using a Cybernic System (Wearable Cyborg HAL and Cyvis100) in collaboration with a local municipality, targeting community-dwelling older adults (healthy, eligible for care prevention, or pre-frail). The program involves weekly exercise sessions for approximately one to two months, in which participants wear the HAL device to perform exercises in rhythm with music, while the Cyvis100 is used to collect physiological data during exercise. Physical function data and mental health indicators will be measured before and after the program to assess the effects of the intervention.
Basic objectives2
Others
Basic objectives -Others
In addition to efficacy, this study will examine the safety of the Wearable Cyborg HAL and Cyvis100, as well as the feasibility of implementing the community-based long-term care and frailty prevention program for older adults.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Sit-to-Stand test, Two-step test, Locomo 25 questionnaire, 10-meter walk test, Hand grip strength, and Functional reach test will be measured before and after the intervention.
Key secondary outcomes
WHO-5 Well-Being Index or short version of the Philadelphia Geriatric Center Morale Scale will be used to evaluate changes in positive affect and life satisfaction before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Perform the exercise regimen with the lumbar-type Hybrid Assistive Limb (HAL) attached.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Participant Condition
Community-dwelling older adults who are independent in their activities of daily living (ADL) and are capable of participating in local community activities or health classes.
Individuals may have lifestyle-related diseases such as hypertension, diabetes, or dyslipidemia, as long as they are not prohibited by a physician from engaging in daily activities or light to moderate exercise.
(2) Age
Approximately 65 years or older at the time of enrollment.
(3) Gender
No restrictions.
(4) Health-related Conditions
Individuals who are able to maintain a standing position and do not have severe musculoskeletal, neurological, or cardiovascular diseases that would interfere with program participation.
(5) Informed Consent
Individuals who have received both oral and written explanations about the purpose and content of the study, have fully understood them, and have provided written informed consent of their own free will.
Key exclusion criteria
Since the participants are recruited from local health promotion classes, it is assumed that all individuals are cleared to engage in physical activity. However, the following conditions should be confirmed, and individuals meeting any of them should be excluded:
Physician restriction: Individuals who are prohibited or cautioned against physical activity by their doctor.
Difficulty with independent walking or standing, or high risk of falling (e.g., 2 or more falls in the past 6 months).
Cardiovascular or respiratory instability: Resting blood pressure >= 180/110 mmHg, resting heart rate >= 120 bpm, unstable angina, heart failure (NYHA class III-IV), use of home oxygen, etc.
Acute phase, infection, or severe pain: Fever >= 37.5 C, active infection, stroke/fracture/surgery in the past 3 months, or joint pain rated >= 7 out of 10 on the NRS scale at rest or with light load.
Device incompatibility: Presence of implantable electrical devices that are incompatible or contraindicated with HAL/Cyvis100, allergy to electrodes or gel, or skin lesions at the application site.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Omiya |
Organization
Graduate School of Medicine, Tohoku University
Division name
Division of Health Science, Department of Public Health Nursing
Zip code
9800875
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
09097130834
toomiya@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Omiya |
Organization
Graduate School of Medicine, Tohoku University
Division name
Division of Health Science, Department of Public Health Nursing
Zip code
9800875
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7925
Homepage URL
toomiya@md.tsukuba.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | 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
Management information
Registered date
| 2025 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067239
