UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045652 |
|---|---|
| Receipt number | R000052116 |
| Scientific Title | Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement |
| Date of disclosure of the study information | 2021/10/04 |
| Last modified on | 2022/09/01 12:16:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Acronym
Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Scientific Title
Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Scientific Title:Acronym
Immediate effect of quick trunk movement on walking ability and lower limb function in stroke patients and mechanism of improvement of walking ability by quick trunk movement
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effect of quick trunk movement on lower limb function and walking ability in stroke patients and its mechanism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait speed
Key secondary outcomes
Coefficient of variation of gait
Gait symmetry
Muscle strength of knee extension
Rate of force development of knee extension
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
quick trunk movement/Number of interventions: 1/pre-intervention/post-intervention
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subacute stroke patients with hemiplegia
2. A person who is able to walk with light assistance or independence with a cane or self-walk
Key exclusion criteria
1. People with severe dementia or higher brain dysfunction who have difficulty understanding the task
2. Individuals with medical and surgical disease that affect the measurement of gait and lower extremity motor function to a degree that affects the measurement of gait and lower extremity motor function
3.Those who exceed the Anderson - Doi criteria by measuring lower extremity motor function
4. Those who received botulinum toxin therapy for the lower extremities within 6 months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | ito |
Organization
Sakurakai Hospital
Division name
rehabilitation department
Zip code
589-0011
Address
5-2610-1 Handa, Osakasayamashi, Osaka prefecture, Japan
TEL
072-366-5757
itoresearch283@gmail.com
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Ito |
Organization
Sakurakai Hospital
Division name
rehabilitation department
Zip code
589-0011
Address
5-2610-1 Handa, Osakasayamashi, Osaka prefecture, Japan
TEL
072-366-5757
Homepage URL
itoresearch283@gmail.com
Sponsor or person
Institute
Sakurakai Hospital
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
Sakurakai Hospital
Address
5-2610-1 Handa, Osakasayamashi, Osaka prefecture, Japan
Tel
072-366-5757
itoresearch283@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
| 2021 | Year | 10 | Month | 04 | 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
10
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | 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 | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052116
