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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044086
Receipt No. R000048955
Scientific Title Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Date of disclosure of the study information 2021/05/01
Last modified on 2021/05/01

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Basic information
Public title Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Acronym Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Scientific Title Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Scientific Title:Acronym Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Vascular surgery Neurosurgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke
Basic objectives2 Others
Basic objectives -Others To analyse the trunk muscle activity during lateral seated reaching task in stroke patients
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Function in sitting test
Outcomes are evaluated before-intervention, 1 and 3 weeks after intervention
Key secondary outcomes Postural Assessment Stroke Scale (PASS)
Trunk impairment scale (TIS)
Stroke Impairment Assessment Set (SIAS)
Scale for Contraversive Pushing (SCP)
Burke Lateropulsion Scale (BLS)
Lateral sitting balance

Outcomes are evaluated before-intervention, 1 and 3 weeks after intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The experimental group 1 sit without leg support on a horizontal surface. The subjects were asked to move their trunk to non-paretic side. This training program is performed 40 times per session, with 4 to 6 sessions in 1 weeks. In addition, the subjects receive conventional physiotherapy.
Interventions/Control_2 The experimental group 2 sit without leg support on a surface tilted 10 degrees to paretic side. The subjects were asked to move their trunk to non-paretic side. This training program is performed 40 times per session, with 4 to 6 sessions in 1 weeks. In addition, the subjects receive conventional physiotherapy.
Interventions/Control_3 Control group perform conventional physical therapy.
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) within 30 days from onset
2) infarction of hemorrahage
3) over 20 years old
4) sitting is not independently
5) stable neurological symtome
6) ability to undertand instructions
Key exclusion criteria 1)none of the above
Target sample size 42

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, Hidaka, Saitama 350-1298, Japan
TEL 0429844367
Email 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, Hidaka, Saitama 350-1298, Japan
TEL +81429844367
Homepage URL
Email fkazuhiro.68@gmail.com

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (KAKENHI)
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 Saitama Medical University International Medical Center
Address 1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel 0429844367
Email imc_irb@saitama-med.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
2021 Year 05 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 Enrolling by invitation
Date of protocol fixation
2020 Year 12 Month 25 Day
Date of IRB
2021 Year 04 Month 16 Day
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2023 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
2021 Year 05 Month 01 Day
Last modified on
2021 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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