UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058828 |
|---|---|
| Receipt number | R000067268 |
| Scientific Title | Differential Peripheral Circulatory Responses to Neuroprosthetic Functional Electrical Stimulation (NP-FES) in Elderly Stroke Patients With Severe and Mild Hemiplegia |
| Date of disclosure of the study information | 2025/08/21 |
| Last modified on | 2025/08/20 10:50:53 |
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Basic information
Public title
Effect of NP-FES (Electrical Stimulation) on Hand Blood Flow in Elderly Stroke Patients
Differences Between Severe and Mild Paralysis
Acronym
NP-FES Blood Flow Study
Scientific Title
Differential Peripheral Circulatory Responses to Neuroprosthetic Functional Electrical Stimulation (NP-FES) in Elderly Stroke Patients With Severe and Mild Hemiplegia
Scientific Title:Acronym
NP-FES Circulation Trial (NP-FES-CirT)
Region
| Japan |
Condition
Condition
Chronic post-stroke hemiplegia
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the effects of Neuroprosthetic Functional Electrical Stimulation (NP-FES) on peripheral circulation in patients with chronic stroke. In particular, the study aims to compare blood flow responses between the severe paralysis group (Brunnstrom Recovery Stage 2 or below) and the mild paralysis group (Brunnstrom Recovery Stage 5 or above), and to identify the onset timing and differences in responsiveness of circulatory improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated blood flow (Q), calculated using a model combining volume waveform, skin temperature, and hemoglobin concentration.
Measurement timing: before stimulation, immediately after stimulation, and 3 minutes post-stimulation
Evaluation points: baseline (0 week), week 2, and week 4
Key secondary outcomes
Patient-reported outcomes obtained through questionnaire/semi-structured interview: subjective experience (usability, cold sensation, pain), changes in self-efficacy, and initiation of daily use
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation (70 Hz, 120 ms) is applied to the paretic extensor muscles, triggered by electromyographic signals from the non-paretic side, to induce joint movement.
Stimulation is delivered for 4 minutes per session.
Frequency: twice a week for 4 weeks (8 sessions in total).
Measurement timing: before stimulation, immediately after stimulation, and 3 minutes post-stimulation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic stroke, at least 1 year after onset
Hemiplegia with Brunnstrom Recovery Stage of 2 or below, or 5 or above
Age 20 years or older
Written informed consent obtained from the participant
Key exclusion criteria
Patients with cognitive impairment that makes it difficult to understand the study or provide informed consent
Patients with severe cardiac, respiratory, or orthopedic conditions that preclude safe intervention
Patients with skin disease, infection, or injury at the electrode placement site
Patients with implanted electronic devices such as pacemakers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Tanabe |
Organization
Faculty of Rehabilitation, Gunma Paz University
Division name
Department of Physical Therapy
Zip code
370-0006
Address
1-7-1 Tonyamachi, Takasaki, Gunma 370-0006, Japan
TEL
027-365-336
tanabe@paz.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Tanabe |
Organization
Faculty of Rehabilitation, Gunma Paz University
Division name
Department of Physical Therapy
Zip code
3703105
Address
1-7-1 Tonyamachi, Takasaki, Gunma 370-0006, Japan
TEL
027-365-3366
Homepage URL
tanabe@paz.ac.jp
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Rehabilitation, Gunma Paz University
Address
1-7-1 Tonyamachi, Takasaki, Gunma 370-0006, Japan
Tel
027-365-3366
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
群馬県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 21 | 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
16
Results
NP-FES improved peripheral circulation in chronic stroke patients. The effect appeared earlier and stronger in severe hemiplegia (Brunnstrom stage 2 or below) than in mild (stage 5 or above). Questionnaires also showed perceived improvement in circulation and warmth in the severe group. Sensory stimulation below motor threshold had no clear benefit. NP-FES may be particularly effective for patients with severe hemiplegia.
Results date posted
| 2025 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Analyzed participants: 16 (8 severe, 8 mild)
Age: mean 76.8 (SD 6.8) years, severe 72.5 (SD 6.5), mild 81.1 (SD 4.0)
Sex: 50 percent male
Duration since stroke onset: mean 9.4 (SD 3.7) years, all at least 1 year
Height: mean 158.3 (SD 9.0) cm
Weight: mean 57.4 (SD 10.7) kg
BMI: mean 22.9 (SD 3.7)
Affected side: Right 7, Left 9
Fugl Meyer Assessment Upper Limb (FMA UL): mean 34.4 (SD 19.7)
Trunk Impairment Scale (TI
Participant flow
A total of 195 individuals were screened across four participating facilities.
Of these, 22 met the inclusion criteria and were enrolled in the study.
During the intervention period, four participants withdrew for health related reasons: worsening heart failure (n=1), COVID-19 infection (n=1), scheduled surgery (n=1), and conflicting medical appointments (n=1).
Two participants with moderate paralysis (Brunnstrom Recovery Stage 3-4) were excluded.
Finally, 16 participants completed all intervention phases and were included in the analysis: 8 with severe paralysis (Brunnstrom Stage 2 or below) and 8 with mild paralysis (Stage 5 or above).
Adverse events
No adverse events related to NP-FES or sensory stimulation were observed.
Four participants withdrew due to health or scheduling reasons (worsening heart failure [n=1], COVID-19 infection [n=1], scheduled surgery [n=1], conflicting medical appointments [n=1]); none were considered related to the intervention.
Outcome measures
Changes in peripheral circulation indices measured by ASTRIM FIT (Sysmex, Japan)
Parameters: venous vessel width (VVW), skin surface temperature, estimated hemoglobin (Hb) levels
Estimated blood flow (Q) calculated from these parameters using a regression model
Measurement points: before, immediately after, and 3 minutes post-stimulation (assessed at baseline, week 2, and week 4)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 10 | 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 | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067268
