UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051267 |
|---|---|
| Receipt number | R000058121 |
| Scientific Title | The Study of Effect of Neuroprosthetic Functional Electrical Stimulation on Finger Vascular Function in Elderly People with Hemiplegia |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2024/06/16 10:38:47 |
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Basic information
Public title
A study of the effects of neuroprosthetic functional electrical stimulation on hand vessels in elderly hemiplegics.
Acronym
NFVFS
Scientific Title
The Study of Effect of Neuroprosthetic Functional Electrical Stimulation on Finger Vascular Function in Elderly People with Hemiplegia
Scientific Title:Acronym
A study to verify the effects of neuroprosthetic functional electrical stimulation on hand vascular function in elderly hemiplegics
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Cardiology | Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to find the optimal conditions for energizing a hemiplegic patient during life to produce dorsiflexion movements of the wrist joint as a neuroprosthetic functional electrical stimulation. Optimal conditions is defined here as conditions that cause as little pain as possible and produce as much dorsiflexion as possible. Furthermore, the aim of this study is to clarify whether there is a difference in responsiveness to electric current compared to healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Versatility index (wrist dorsiflexion angle/pain)
Key secondary outcomes
Dorsiflexion angle of wrist joint, Pain Numerical Rating Scale (NRS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention 1: Three dorsiflexion movements with energization at 35 Hz conditions. The order of interventions will be implemented randomly and there will be no washout period.
Interventions/Control_2
Intervention 2: Three dorsiflexion movements with energization at 70 Hz conditions. The order of interventions will be implemented randomly and there will be no washout period.
Interventions/Control_3
Intervention 3: Three dorsiflexion movements with energization at 120 Hz conditions. The order of interventions will be implemented randomly and there will be no washout period.
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
| 45 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemiplegics were defined as having at least 3 lower extremities and 4 fingers at the Brunnstrom stage (BRS).
Key exclusion criteria
Patients with the following conditions were excluded. Those with peripheral neuropathy, Mini Mental State Examination (MMSE) scores of 10 or less, and those with severe dementia who were unable to make decisions on their own regarding cooperation in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Tanabe |
Organization
Gunma PAZ University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
3700006
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture
TEL
0273653366
tanabe@paz.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Tanabe |
Organization
Gunma PAZ University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
3700006
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture
TEL
0273653366
Homepage URL
tanabe@paz.ac.jp
Sponsor or person
Institute
Gunma PAZ University
Institute
Department
Personal name
TanabeMasaya
Funding Source
Organization
Gunma PAZ University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Perth University Ethics Review Committee
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture
Tel
0273653366
tanabe@paz.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
| 2023 | Year | 06 | Month | 10 | 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
21
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none in particular
Outcome measures
Maximal dorsiflexion angle of wrist joint, pain, versatility index (calculated as maximal dorsiflexion angle of wrist joint/pain)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058121
