UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054211 |
|---|---|
| Receipt number | R000061901 |
| Scientific Title | Long-term impact of lateral truncal tilt training in sitting position with a wedge on learning postural control in patients with hemiplegia: A double-blind, randomized, crossover controlled trial. |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/21 12:26:22 |
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Basic information
Public title
Long-term impact of lateral truncal tilt training in sitting position with a wedge on learning postural control in patients with hemiplegia: A double-blind, randomized, crossover controlled trial.
Acronym
Long-term impact of lateral truncal tilt training in sitting position with a wedge on learning postural control in patients with hemiplegia: A double-blind, randomized, crossover controlled trial.
Scientific Title
Long-term impact of lateral truncal tilt training in sitting position with a wedge on learning postural control in patients with hemiplegia: A double-blind, randomized, crossover controlled trial.
Scientific Title:Acronym
Long-term impact of lateral truncal tilt training in sitting position with a wedge on learning postural control in patients with hemiplegia: A double-blind, randomized, crossover controlled trial.
Region
| Japan |
Condition
Condition
Cases with hemiplegia, pusher behavior and unilateral spatial neglect
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effects of the long-term impact of lateral truncal tilt training on learning postural control in patients with hemiplegia, pusher behavior, and unilateral spatial neglect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
center of pressure; CoP
Brain activity
Key secondary outcomes
Scale for contraversive Pushing; SCP
Trunk Control Test; TCT
Berg Balance Scale; BBS
Functional Independence Measure; FIM
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Specific trining; wedge training
Interventions/Control_2
Conventional training; without wedge training
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria are being able to sit when observing a person and having suffered the first-ever stroke.
Key exclusion criteria
The exclusion criteria are cerebellar lesions, multiple cerebral infarctions, poor instruction comprehension, and orthopedic history.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
TEL
+03-80-1207-9205
k-sawa@sbctmu.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
TEL
08012079205
Homepage URL
k-sawa@sbctmu.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
SBC Tokyo Medical University
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
SBC Tokyo Medical University
Address
5-8-1, Akemi, Urayasu, Chiba, Japan, 279-8567
Tel
08012079205
k-sawa@sbctmu.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
| 2024 | Year | 04 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 04 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061901
| 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 |
