UMIN-ICDS Clinical Trial

Public title

Exploratory study of stimulation-site selection and individualized intervention using sensory-threshold neuromuscular electrical stimulation in patients with post-stroke hemiparesis

Acronym

Sensory-threshold NMES study in stroke

Scientific Title

Exploratory study of stimulation-site selection and individualized intervention using sensory-threshold neuromuscular electrical stimulation in patients with post-stroke hemiparesis

Scientific Title:Acronym

Sensory-threshold NMES study in stroke

Region

Japan

Condition

Stroke with hemiparesis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the immediate effects of sensory-level neuromuscular electrical stimulation (S-NMES) applied to the tibialis anterior and triceps surae on postural control and gait in patients with post-stroke hemiparesis, and to explore changes in balance and gait following a 2-week individualized intervention in which the stimulation site is selected based on the immediate response.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Improvement rate in mediolateral (ML) center of pressure (CoP) path length during quiet standing with eyes closed at the immediate assessment. On both the tibialis anterior (TA) and triceps surae (TS) stimulation days, two trials are performed before S-NMES (no-stimulation condition) and during S-NMES. The improvement rate is calculated as the difference between the mean no-stimulation value and the mean during-stimulation value, divided by the mean no-stimulation value, and multiplied by 100 percent.

Key secondary outcomes

Mini-Balance Evaluation Systems Test (Mini-BESTest): Change from baseline to the end of the 2-week intervention will be assessed. For participants available for follow-up, the Mini-BESTest will also be assessed 2 weeks after completion of the intervention.
Center of pressure (CoP) measures: CoP velocity and mediolateral (ML) and anteroposterior (AP) CoP path lengths will be assessed during the immediate assessment (before and during S-NMES), at baseline, at the end of the 2-week intervention, and, when feasible, 2 weeks after completion of the intervention.
Gait measures: gait speed, gait cycle time variability, stance time variability, and stride length will be assessed during the immediate assessment (before and during S-NMES), at baseline, at the end of the 2-week intervention, and, when feasible, 2 weeks after completion of the intervention.
Other clinical measures: Berg Balance Scale (BBS), Fugl-Meyer Assessment of lower-extremity motor and sensory function, Modified Ashworth Scale (MAS), plantar tactile sensation, vibration sensation, Subjective Visual Vertical (SVV), and modified Clinical Test of Sensory Interaction on Balance (mCTSIB) will be assessed at baseline, at the end of the 2-week intervention, and, when feasible, 2 weeks after completion of the intervention.
Exploratory outcomes include CoP root mean square (RMS), mean power frequency (MPF), median power frequency (MdPF), and intermuscular coherence between the paretic tibialis anterior and soleus muscles.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

During the immediate assessment, sensory-level neuromuscular electrical stimulation (S-NMES) is applied to the paretic tibialis anterior (TA) on Day 1 and to the paretic triceps surae (TS) on Day 2. On each stimulation day, measurements are performed before S-NMES under the no-stimulation condition and then during S-NMES. Stimulation parameters are 100 Hz, a pulse width of 200 microseconds, an intensity approximately 1.5 times the sensory threshold without visible muscle contraction, and a stimulation duration of 40 minutes. After completion of the immediate assessments for both TA and TS stimulation, the stimulation site for the 2-week intervention is individually selected based on the improvement rate in mediolateral CoP path length during standing with eyes closed. S-NMES is then applied to the selected site once daily for 40 minutes on intervention days for 2 weeks.

Interventions/Control_2

During the immediate assessment, sensory-level neuromuscular electrical stimulation (S-NMES) is applied to the paretic triceps surae (TS) on Day 1 and to the paretic tibialis anterior (TA) on Day 2. On each stimulation day, measurements are performed before S-NMES under the no-stimulation condition and then during S-NMES. Stimulation parameters are 100 Hz, a pulse width of 200 microseconds, an intensity approximately 1.5 times the sensory threshold without visible muscle contraction, and a stimulation duration of 40 minutes. After completion of the immediate assessments for both TA and TS stimulation, the stimulation site for the 2-week intervention is individually selected based on the improvement rate in mediolateral CoP path length during standing with eyes closed. S-NMES is then applied to the selected site once daily for 40 minutes on intervention days for 2 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients aged 20 years or older with first-ever unilateral stroke and hemiparesis whose general condition is stable.
2.Patients who are able to maintain quiet standing with the feet together for 60 seconds without physical assistance.
3.Patients who are able to walk 10 m with supervision.
4.Patients in whom the sensory threshold can be determined and sensory-level electrical stimulation according to the study protocol can be safely applied.
5.Patients who receive written and verbal explanations of the study and provide written informed consent.

Key exclusion criteria

1.Patients with neurological diseases other than stroke.
2.Patients with severe orthopedic disorders that clearly affect balance.
3.Patients with severe peripheral neuropathy.
4.Patients with visual impairment such as hemianopia that interferes with study procedures, severe hearing impairment, dizziness, or evident vestibular disorders.
5.Patients who are unable to safely and consistently complete the study procedures because of cognitive or communication impairment.
6.Patients with conditions for which electrical stimulation is considered unsafe, such as the use of implanted electrical devices.
7.Patients considered unsuitable for participation by the principal investigator for safety reasons or because of concerns regarding interpretation of the data.

Target sample size

5

Name of lead principal investigator

1st name	Akinori
Middle name
Last name	Tsuchiya

Organization

Ukai Rehabilitation Hospital

Division name

Department of Rehabilitation

Zip code

4530811

Address

4-1 Taikodori, Nakamura-ku, Nagoya, Aichi, Japan

TEL

052-461-3132

Email

labradoor.yellow@gmail.com

Name of contact person

1st name	Akinori
Middle name
Last name	Tsuchiya

Organization

Ukai Rehabilitation Hospital

Division name

Department of Rehabilitation

Zip code

4530811

Address

4-1 Taikodori, Nakamura-ku, Nagoya, Aichi, Japan

TEL

052-461-3132

Homepage URL

Email

labradoor.yellow@gmail.com

Institute

Ukai Rehabilitation Hospital

Institute

Department

Personal name

Organization

Kio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee, Kio University

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan

Tel

0745-54-1601

Email

kansa@kio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

27

Day

Date of IRB

Anticipated trial start date

2026

Year

10

Month

15

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

30

Day

Last modified on

2026

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072247