UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044942 |
|---|---|
| Receipt number | R000051337 |
| Scientific Title | Effect of balance exercise by real-time postural feedback system for patients with chronic stroke |
| Date of disclosure of the study information | 2021/07/22 |
| Last modified on | 2023/07/23 22:06:45 |
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Basic information
Public title
Effect of balance exercise by real-time postural feedback system for patients with chronic stroke
Acronym
Effect of balance exercise by real-time postural feedback system for patients with chronic stroke
Scientific Title
Effect of balance exercise by real-time postural feedback system for patients with chronic stroke
Scientific Title:Acronym
Effect of balance exercise for patients with chronic stroke
Region
| Japan |
Condition
Condition
Patients with ischemic or hemorrhagic stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To show the effect of balance exercise using a real-time postural feedback system of long-term intervention in a randomized controlled trial (RCT) in comparison with traditional balance exercise
2) To confirm the sustained effect after the end of the intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Balance and walking ability
Key secondary outcomes
Knee extension muscle strength, self-efficacy for falling and walking
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Balance exercise (twice a week, two sets of 1 min per session, for a total of 2 min per session) by using the stabilometer installed with the function of disturbance generation (BASYS, Tec Gihan Co. Ltd., Kyoto, Japan) for 6 weeks
Interventions/Control_2
Balance exercise (twice a week, two sets of 1 min per session, for a total of 2 min per session) by using a polyurethane mat (StimUp Balance Pad, Celcom, Inc., Fukuoka, Japan) for 6 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
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ischemic or hemorrhagic stroke of at least 12 months duration
2) ability to walk at least 10 m with or without assistive devices
3) Able to communicate verbally
Key exclusion criteria
1) Patients with a history of treatment for orthopedic or musculoskeletal injuries affecting the lower extremities at the time of recruitment
2)Patients with a history of neurological dysfunction, such as seizure disorder, head injury, and peripheral neuropathy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Suzuki |
Organization
Matterhorn Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
7370046
Address
1-5-25, Nakado-ri, Kure 737-0046 Japan
TEL
0823226868
yt.suzuki28@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Suzuki |
Organization
Matterhorn Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
7370046
Address
1-5-25, Nakado-ri, Kure 737-0046 Japan
TEL
0823226868
Homepage URL
yt.suzuki28@gmail.com
Sponsor or person
Institute
Matterhorn Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matterhorn Rehabilitation Hospital
Address
1-5-25, Nakado-ri, Kure 737-0046 Japan
Tel
0823226868
matter@jasmine.ocn.ne.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
マッターホルンリハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
