UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028446 |
|---|---|
| Receipt number | R000031199 |
| Scientific Title | Effect of Sitting Balance Training on Diagonal Plane in Patients with Acute stroke |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/08/12 21:08:36 |
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Basic information
Public title
Effect of Sitting Balance Training on Diagonal Plane in Patients with Acute stroke
Acronym
Effect of Sitting Balance Training on Diagonal Plane in Patients with Acute stroke
Scientific Title
Effect of Sitting Balance Training on Diagonal Plane in Patients with Acute stroke
Scientific Title:Acronym
Effect of Sitting Balance Training on Diagonal Plane in Patients with Acute stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the short term effects of sitting balance training in diagonal plane in patients with stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Function in Sitting Test
*Primary outcome is assessed before the first intervention and 8 days later.
Key secondary outcomes
Stroke Impairment Assessment Set (SIAS)
Subjective Postural Vertical(SPV)
Trunk control Test (TCT)
Trunk impairment scale(TIS)
Functinal Independence Measure (FIM)
*Secondary outcomes are assessed before the first intervention and 8 days later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The experimental groups sit without leg support on a platform tilted 10 degrees diagonally to back ward paretic side, while the controls seat on horizontal platform. The subjects were asked to move their trunk giagonally to forward non-paretic side. This training program is performed 40 times per session, with 7 sessions in 8 days. The subjects in both groups received conventional physiotherapy and occupational therapy for 1 hour each per day.
Interventions/Control_2
The control groups sit without leg support on a horizontal platform. The subjects were asked to move their trunk giagonally to forward non-paretic side. This training program is performed 40 times per session, with 7 sessions in 8 days. The subjects in both groups received conventional physiotherapy and occupational therapy for 1 hour each per day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) no history of stroke
2) over 20 years old
3) within 60 days from onset
4) the score of FIST is 1 or 2 or 3
5) difisulty of independent standing posture
6) stable neurological symtom
7) no history of neurological and orthopedic problem
8) no history of dimentia and psychiatric disorder
9)ability to undertand instructions
Key exclusion criteria
1)none of the above
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
saitama medical university international medical center
Division name
Department of Rehabilitation Center
Zip code
350-1298
Address
1397-1, yamane, hidakashi, saitama
TEL
042-984-4367
fkazuhiro.68@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
saitama medical university international medical center
Division name
Department of Rehabilitation Center
Zip code
350-1298
Address
1397-1, yamane, hidakashi, saitama
TEL
042-984-4367
Homepage URL
fkazuhiro.68@gmail.com
Sponsor or person
Institute
saitama medical university international medical center
Institute
Department
Personal name
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
Saitama International University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel
0429844367
fkazuhiro.68@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
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/abs/10.1080/09638288.2019.1688873
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/abs/10.1080/09638288.2019.1688873
Number of participants that the trial has enrolled
33
Results
Treatment effects differed significantly: mean differences between groups for FIST (total score, static, dynamic, scooting, and reactive) were 8.96, 2.35, 3.01, 1.27, and 1.72 points, for the mean SPV value was 1.82 degree, and for the TIS (total score and static) were 1.87 and 1.58 points, respectively. These results were more favourable in the experimental group.
Results date posted
| 2020 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The demographic data of the two groups
are no significant difference on age, sex, Time from stroke onset, lesion side, etiology.
Participant flow
Thirty-three stroke patients were randomly allocated into 16 intervention group and 17 control group.
Adverse events
None
Outcome measures
Function in sitting test (FIST)
subjective postural vertical (SPV) on the diagonal plane
Trunk impairment scale (TIS)
Stroke impairment stroke set(SIAS)
Trunk control test(TCT)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 30 | Day |
Last modified on
| 2020 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/07/12 | participants data.xlsx |
