UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035875 |
|---|---|
| Receipt number | R000040871 |
| Scientific Title | Development and validation of upper limb function training robot for hemiplegic patients - Examination of muscle synergy by electromyogram analysis- |
| Date of disclosure of the study information | 2019/02/14 |
| Last modified on | 2025/02/18 13:54:27 |
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Basic information
Public title
Development and validation of upper limb function training robot for hemiplegic patients - Examination of muscle synergy by electromyogram analysis-
Acronym
Study on upper limb rehabilitation robot in patients with hemiplegia
Scientific Title
Development and validation of upper limb function training robot for hemiplegic patients - Examination of muscle synergy by electromyogram analysis-
Scientific Title:Acronym
Study on upper limb rehabilitation robot in patients with hemiplegia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to aim for the development of a system that evaluates motor learning by muscle synergy analysis of stroke patients and provides appropriate rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ï½¥muscle synergy
Key secondary outcomes
Stroke Impairment Assessment Set (SIAS)
Brunnstrom Stage
Functional Independence Measure (FIM)
Fugl-Meyer assessment
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention and assessment are performed using Synergy-01.
The frequency of the interventions for inpatients is four times in total at two weeks intervals.
Inpatients are intervened on the same day as the evaluation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with hemiplegia in a rehabilitation ward
The general condition is stable
Patients can keep sitting
Informed-consent has been obtained
Key exclusion criteria
High-blood pressure(systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg or resting heart rate > 120/min)
Restricted exercise due to heart function or respiratory function disorder
Hearing or visual impairment
Dementia or severe higher brain dysfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Institute of Physical and Chemical Research Brain Science Institute
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyota Motor Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrices and Gerontology
Address
7-430, Moriokachou, Obu, Aichi
Tel
0562-46-2311
ik7710@ncgg.go.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
| 2019 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
Results
Muscle synergy feedback with Synergy01 may be safe and effective.
Results date posted
| 2025 | Year | 02 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
The average age of all subjects was 73 years old, 51% male, and the primary disease was infarction in 63%, hemorrhage in 37%, and the affected side was right side in 44% and left side in 56%.
Participant flow
Forty-three patients participated in the study, they allocated 21 in synergy group and 22 in control group. Four patients in each group dropped out due to early discharge from the hospital. Finally, 17 patients in synergy group and 18 patients in control group were included in the analysis.
Adverse events
No serious adverse events or TRDs occurred during the study period.
Outcome measures
Primary endpoint
Synergy group: FMA 31.6 to 37.8 (p<0.001)
Control group: FMA 32.0 to 35.5 (p=0.018)
Comparison of FMA change between the two groups: 6.2 vs 3.5 (p=0.028)
As a result of comparing the amount of change in FMA, there was statistically significant difference between the two groups. His primary endpoint, his FMA, showed superiority of Synergy01.
Plan to share IPD
None.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040871
