UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056697 |
|---|---|
| Receipt number | R000064811 |
| Scientific Title | The Effect of Gait Training with Rhythmic Vibrotactile Cueing on Walking Function in Post-Stroke Patients During the Recovery Phase: A Pilot Study Toward a Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2026/05/28 21:19:53 |
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Basic information
Public title
The Effect of Gait Training with Rhythmic Vibrotactile Cueing on Walking Function in Post-Stroke Patients During the Recovery Phase: A Pilot Study Toward a Randomized Controlled Trial
Acronym
The Effect of Gait Training with Rhythmic Vibrotactile Cueing on Walking Function in Post-Stroke Patients During the Recovery Phase: A Pilot Study Toward a Randomized Controlled Trial
Scientific Title
The Effect of Gait Training with Rhythmic Vibrotactile Cueing on Walking Function in Post-Stroke Patients During the Recovery Phase: A Pilot Study Toward a Randomized Controlled Trial
Scientific Title:Acronym
The Effect of Gait Training with Rhythmic Vibrotactile Cueing on Walking Function in Post-Stroke Patients During the Recovery Phase: A Pilot Study Toward a Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Cerebrovascular Disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness of gait training using rhythmic vibrotactile cueing in improving walking function in patients with cerebrovascular disease. Additionally, as a pilot study preceding the implementation of a randomized controlled trial, this study seeks to calculate the effect size required to determine the sample size for the randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking speed(pre and post intervention)
Key secondary outcomes
Cadence(pre and post intervention)
Stride Length(pre and post intervention)
Gait Cycle Percentage(pre and post intervention)
Japanese Version of the Revised Gait Efficacy Scale(pre and post intervention)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait training is conducted with rhythmic cueing provided by a vibrotactile stimulation device. The rhythmic stimulation is set to a value 10% higher than the cadence calculated during the initial assessment. The intervention period consists of 30-minute sessions (6 sets of 5 minutes each) performed daily, 7 days a week, for 2 weeks. Rehabilitation during the remaining time follows standard physical therapy practices.
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 at our hospital
Patients with a first onset of the condition, at least one month post-onset
Patients with a Brunnstrom Stage of lower extremity Stage III or higher
Patients classified as Level 3 or higher on the Functional Ambulation Categories (able to walk independently without assistance)
Patients capable of walking without the use of walking aids other than a cane (use of lower limb orthoses is permitted)
Key exclusion criteria
Patients with cognitive impairment (Mini-Mental State Examination score below 24)
Patients with higher brain dysfunction
Patients with difficulty perceiving vibrotactile stimulation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Nakamura |
Organization
Sonodakai Neuro Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
120-0012
Address
Aoi 1-10-10 Adachi-ku, Tokyo
TEL
03-5845-0126
ko.ta1994.01.27@gmail.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Nakamura |
Organization
Sonodakai Neuro Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
120-0012
Address
Aoi 1-10-10 Adachi-ku, Tokyo
TEL
03-5845-0126
Homepage URL
ko.ta1994.01.27@gmail.com
Sponsor or person
Institute
Sonodakai Neuro Rehabilitation Hospital
Institute
Department
Personal name
Nakamura Kota
Funding Source
Organization
None
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
Sonodakai Neuro Rehabilitation Hospital
Address
Aoi 1-10-10 Adachi-ku, Tokyo
Tel
03-5845-0126
ko.ta1994.01.27@gmail.com
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
| 2025 | Year | 01 | Month | 13 | 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
10
Results
Ten subacute stroke patients underwent RVS-guided gait training for 2 weeks (30 min/day, 7 days/week). Post-intervention, the 10m maximal gait test showed significant improvements in gait speed (p=0.00126), cadence (p=0.00213), and stride length (p=0.0015). The mGES (p=0.0615) and Symmetry Ratio (p=0.398) showed positive trends but no significant differences. RVS gait training may effectively improve spatiotemporal parameters in this population.
Results date posted
| 2026 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten stroke patients admitted to Sonodakai Neurorehabilitation Hospital who met the predefined eligibility criteria were enrolled in this study (n = 10). The baseline demographic and clinical characteristics of the study cohort included a mean age of 71.9 +/- 11.5 years, comprising 5 males and 5 females. Regarding stroke etiology, 8 participants had a cerebral infarction and 2 had an intracerebral hemorrhage, with a mean time since stroke onset of 92.1 +/- 30.5 days. The neurological and functional statuses evaluated at baseline were as follows: Brunnstrom Recovery Stage for the lower extremity was Stage III in 1 participant, Stage IV in 3, Stage V in 4, and Stage VI in 2; Functional Ambulation Categories (FAC) was Category 4 in 6 participants and Category 5 in 4; the mean Mini-Mental State Examination (MMSE) score for cognitive function was 27.0 +/- 2.1; and lower-limb orthosis utilization was present in 2 participants. The inclusion criteria required individuals to have a stroke, a Brunnstrom Recovery Stage for the lower extremity of >= III, a Functional Ambulation Categories of >= 3, and the ability to ambulate without assistive devices other than a cane, though the use of a lower-limb orthosis was permitted. Individuals were excluded if they presented with cognitive impairment (Mini-Mental State Examination score < 24), higher brain dysfunction, or sensory deficits that rendered the perception of vibrotactile stimulation difficult.
Participant flow
A total of 10 participants were screened and provided written informed consent for enrollment in this single-center, single-arm study, and all 10 participants were subsequently allocated to the rhythmic vibrotactile stimulation (RVS) intervention group (n = 10). All 10 participants successfully completed the designated 2-week intervention program without any dropouts or withdrawals. Consequently, data from all 10 allocated participants (n = 10) were included in the final statistical analysis, with no missing data or exclusions.
Adverse events
No serious adverse events or device-related complications associated with the application of the vibrotactile device or the gait training protocol were reported or documented during the study period.
Outcome measures
The primary outcome measures were the spatiotemporal gait parameters derived from the 10-meter maximal gait test assessed at baseline and post-intervention, which included maximal gait speed (m/sec), cadence (steps/min), and stride length (cm). The secondary outcome measures consisted of the Symmetry Ratio (SR), calculated based on the stance phase percentage of the gait cycle using a three-dimensional motion analysis system (myoMOTION; Sakai Med Co., Ltd.), and psychological gait efficacy, evaluated using the total score of the Japanese version of the modified Gait Efficacy Scale (mGES).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2025 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064811
