UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041596 |
|---|---|
| Receipt number | R000047486 |
| Scientific Title | Effect of unstable board intervention on non-paralyzed lower limbs on trunk function and activities of daily living for severe stroke patients |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2022/07/04 08:01:28 |
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Basic information
Public title
Effect of unstable board intervention on non-paralyzed lower limbs on trunk function and activities of daily living for severe stroke patients
Acronym
Efficacy of intervention with unstable plates for patients with severe stroke
Scientific Title
Effect of unstable board intervention on non-paralyzed lower limbs on trunk function and activities of daily living for severe stroke patients
Scientific Title:Acronym
Efficacy of intervention with unstable plates for patients with severe stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Vascular surgery | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of physiotherapy combined with unstable plate for severe stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Index of Postural Stability,Angles of the neck, trunk and both lower legs in the standing reaction to a lateral tilt stimulus, Distance of center of gravity shift during RR for lateral tilt stimulus, Trunk Impairment Scale, Functional Independent Measure
Key secondary outcomes
Brunnstrom Recovery Stage,Sensory,Function Ambulation Categories
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention with unstable boards
15-20 minutes a day 3 times a week
Interventions/Control_2
Normal intervention
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
| 21 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
first ever stroke cases (lesions on the tent) admitted to recovery wards, Able to hold a sitting position for at least 1 minute under supervision, able to understand instructions, Motor items on the Functional Independence Measure (FIM) less than 46 points, Difficulty walking and using a knee ankle foot orthosis (KAFO).
Key exclusion criteria
Those who have a history of orthopedic diseases, those who have internal medical disorders that interfere with getting out of bed, those who have orthostatic hypotension, and those who have lesions that cause balance disorders such as the brain stem and cerebellum.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Nagai |
Organization
Hanahata Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
121-0061
Address
5-12-29, Hanabata, Adachi-ku, Tokyo, Japan
TEL
03-5242-1108
baseballer.k.n891106@gmail.com
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Nagai |
Organization
Hanahata Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
121-0061
Address
5-12-29, Hanabata, Adachi-ku, Tokyo, Japan
TEL
03-5242-1108
Homepage URL
baseballer.k.n891106@gmail.com
Sponsor or person
Institute
Hanahata Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Hanahata Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sonodakai Ethics Committee
Address
1-21-10 Hokima, Adachi-ku, Tokyo, Japan
Tel
03-5831-1811
irb@sonodakai.or.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
医療法人社団苑田会 花はたリハビリテーション病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047486
