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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028446
Receipt No. 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 2018/08/07

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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
Middle name
Last name Kazuhiro Fukata
Organization saitama medical university international medical center
Division name Department of Rehabilitation Center
Zip code
Address 1397-1, yamane, hidakashi, saitama
TEL 042-984-4367
Email fkazuhiro.68@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Fukata
Organization saitama medical university international medical center
Division name Department of Rehabilitation Center
Zip code
Address 1397-1, yamane, hidakashi, saitama
TEL 042-984-4367
Homepage URL
Email fkazuhiro.68@gmail.com

Sponsor
Institute saitama medical university international medical center
Institute
Department

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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 20 Day
Date of IRB
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
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.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


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