UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051277 |
|---|---|
| Receipt number | R000058128 |
| Scientific Title | The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia |
| Date of disclosure of the study information | 2023/06/08 |
| Last modified on | 2025/06/09 09:51:56 |
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Basic information
Public title
The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia
Acronym
The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia
Scientific Title
The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia
Scientific Title:Acronym
The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia B
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Cardiology | Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of continuous Neuroprosthetic functional electrical stimulation (NP-FES) on peripheral circulatory function in living-phase hemiplegics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Venous vessel width (before and after energization) Measurements at baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks after intervention 1 and intervention 2 for 2 cools.
Key secondary outcomes
Skin surface temperature, venous oxygenation index, estimated hemoglobin level (before and after energization) Measurements at baseline, 1, 2, 3, and 4 weeks after intervention 1 and intervention 2 for 2 cools.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention 1: Dorsiflexion movement with energization under 70 Hz conditions for 4 minutes. The rhythm of the energization consists of 2 seconds of energization and 2 seconds of rest. This will be performed twice a week. The washout period will be 2 weeks. The intensity of the stimulation should be the maximum intensity that can be tolerated by the individual producing the joint movement.
Interventions/Control_2
Intervention 2: 4 minutes of energization under 70 Hz conditions, followed by dorsiflexion. The rhythm of the energization consists of 2 seconds of energization and 2 seconds of rest. This will be performed twice a week. The washout period will be 2 weeks. The intensity of the stimulation should be about the level of sensory energization, and joint movements should not be produced.
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
| 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
370-0006
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 | 08 | Day |
Related information
URL releasing protocol
inthepipeline
Publication of results
Unpublished
Result
URL related to results and publications
inthepipeline
Number of participants that the trial has enrolled
22
Results
In the severe paraplegia group, the difference before implementation tends to exceed the difference after 3 minutes of implementation (BF10=4.28).
Results date posted
| 2025 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Those who have been using day-care rehabilitation facilities at least twice a week for at least one year since the onset of stroke.
Severe paralysis group (Brunnstrom Recovery Stage 2 or below): 8
Paralysis light (Brunnstrom Recovery Stage 5 or above): 8
Gender: 8 males and 8 females
Mean age: 69.2years SD8.4 years
Participant flow
Twenty-two subjects were included, in random order, with intervention (NP-FES) and without intervention (no joint exercise).Each intervention period lasted one month, with a 2-week washout period in the middle.
Subjects who dropped out included those hospitalized for infection, those for whom periodic periodic assessment was no longer possible due to periodic examinations, those who required surgery due to pre-existing periodic examinations, and those hospitalized due to exacerbation of pre-existing heart failure.None were offered termination due to adverse events or loss of motivation.The current analysis included results for 8 patients with severe paralysis and 8 patients with mild paralysis.
Adverse events
There were no adverse events.
Outcome measures
The blood flow estimator Q, consisting of skin surface temperature and venous vessel width, was calculated by the maximum likelihood estimation method and used as the outcome.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058128
