UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063330 |
|---|---|
| Receipt number | R000072429 |
| Scientific Title | Effects of Eyes-Closed Standing Training on a Foam Surface on Postural Control in Patients With Stroke: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/25 |
| Last modified on | 2026/10/18 18:14:20 |
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Basic information
Public title
Effects of Eyes-Closed Standing Training on a Foam Surface on Postural Control in Patients With Stroke: A Multicenter Randomized Controlled Trial
Acronym
Effects of Eyes-Closed Standing Training on a Foam Surface in Stroke
Scientific Title
Effects of Eyes-Closed Standing Training on a Foam Surface on Postural Control in Patients With Stroke: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
Effects of Eyes-Closed Standing Training on a Foam Surface on Postural Control in Patients With Stroke: A Multicenter Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the short-term effects of one week of eyes-closed standing training on a foam surface on static standing postural control and balance performance in patients with stroke, compared with usual rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief-BESTest total score
The Brief-BESTest will be assessed at baseline and after the 1-week intervention. Changes in the total score will be compared between the Mat and Control groups.
Key secondary outcomes
1. Scores of individual Brief-BESTest items
2. Trunk acceleration measures during quiet standing: root mean square (RMS) acceleration in the anteroposterior (AP) and mediolateral (ML) directions, jerk, frequency characteristics, power spectral density (PSD), mean or median frequency, and acceleration trajectory area.
Quiet standing will be assessed under three conditions: eyes open on a firm surface, eyes closed on a firm surface, and eyes closed on a foam surface. All outcomes will be assessed at baseline and after the 1-week intervention and compared between groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The Mat group will receive standing training using a standardized balance mat (manufactured by Hapquitous Inc., EquiTest-compliant, and designed for frailty and vestibular function assessment) as part of a 60-minute usual rehabilitation session. The standing task will be performed primarily with eyes closed, with the feet positioned 10 cm apart and the arms crossed over the chest. Training will consist of up to six 30-second sets per session, five times per week for one week. After each intervention session, subjective task difficulty will be assessed using a Visual Analog Scale (VAS).
The intervention will be discontinued if the Borg Scale score reaches 15 or higher, if the participant is unable to maintain standing safely, if the participant requests discontinuation, or if the treating physical therapist determines that continuation is unsafe.
Interventions/Control_2
The Control group will receive 60 minutes of usual rehabilitation. No additional standing training on an unstable support surface will be provided as part of the study. Usual rehabilitation may include range-of-motion exercises, muscle strengthening exercises, standing and balance training, gait training, and activities of daily living (ADL) training. The content of usual rehabilitation in both groups will be recorded using a standardized checklist.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with first-ever stroke.
2. Hospitalized patients undergoing rehabilitation.
3. Patients who are able to perform standing tasks under appropriate safety supervision.
4. Patients who are able to understand the instructions for the study tasks.
5. Patients who provide written informed consent after receiving an explanation of the study.
Key exclusion criteria
1. Patients with orthopedic disorders that substantially affect standing and balance performance.
2. Patients with neurological disorders other than stroke.
3. Patients with comorbidities, such as severe heart failure, that may compromise the safe performance of standing tasks.
4. Patients who have difficulty understanding or performing the study tasks due to severe cognitive impairment or other conditions.
5. Patients who are judged by the treating physician or physical therapist to be unable to participate in the study for other reasons.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Rai |
| Middle name | |
| Last name | Sugiyama |
Organization
Fukuoka rehabilitation hospital
Division name
Department of Rehabilitation
Zip code
819-8551
Address
7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka 819-8551, Japan
TEL
092-812-1555
25624007@edu.cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Sugiyama |
| Middle name | |
| Last name | Rai |
Organization
Fukuoka Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
819-8551
Address
7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka 819-8551, Japan
TEL
819-8551
Homepage URL
25624007@edu.cc.saga-u.ac.jp
Sponsor or person
Institute
Fukuoka Rehabilitation Hospital
Institute
Department
Personal name
Rai Sugiyama
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saga Rehabilitation Hospital
Yohkoh Rehabilitation Hospital
Yanagawa Rehabilitation Hospital
Yamagata Saisei Hospital
Fukuoka Sanno Hospital
Kyushu University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Fukuoka Rehabilitation Hospital
Address
7-770 Nokata, Nishi-ku, Fukuoka, Fukuoka 819-8551, Japan
Tel
092-812-1555
25624007@edu.cc.saga-u.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
| 2026 | Year | 10 | Month | 25 | 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
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | 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
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072429
