UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054578 |
|---|---|
| Receipt number | R000062365 |
| Scientific Title | Factors affecting the left-right gait asymmetry in stroke patients |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2025/06/06 10:26:38 |
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Basic information
Public title
Factors affecting the left-right gait asymmetry in stroke patients
Acronym
Factors affecting the left-right gait asymmetry in stroke patients
Scientific Title
Factors affecting the left-right gait asymmetry in stroke patients
Scientific Title:Acronym
Factors affecting the left-right gait asymmetry in stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to investigate factors affecting the left-right asymmetry of trunk movement during gait in subacute stroke patients.
Basic objectives2
Others
Basic objectives -Others
Evaluation of gait stability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An index of trunk asymmetry calculated from acceleration during walking (Lissajous Index)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with a first-time stroke.
(2)The ability to walk independently for > 12 m without assistance.
Key exclusion criteria
(1) a history of orthopedic or neurological diseases other than stroke
(2) the presence of ataxia
(3) the presence of dementia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshino |
| Middle name | |
| Last name | Terui |
Organization
Akita University Graduate School of Health Sciences
Division name
Physical Therapy
Zip code
010-8543
Address
Hondo, Akita City, Akita
TEL
018-884-6504
terui@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshino |
| Middle name | |
| Last name | Terui |
Organization
Akita University Graduate School of Health Sciences
Division name
Physical Therapy
Zip code
010-8543
Address
1-1, Hondo, Akita City, Akita
TEL
018-884-6504
Homepage URL
terui@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita Prefectural Center for Rehabilitation and Psychiatric Medicine
Address
352, Kyowa, Daisen City, Akita
Tel
018-892-3751
info@akita-hos.or.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 | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://malque.pub/ojs/index.php/msj/article/view/4608
Publication of results
Published
Result
URL related to results and publications
https://malque.pub/ojs/index.php/msj/article/view/4608
Number of participants that the trial has enrolled
52
Results
Lissajous Index evaluates the left-right symmetry during walking. The Lissajous Index at 2 months after baseline was significantly lower than that at baseline (p < 0.05). A multiple regression analysis showed that the effect of trunk muscle strength was significantly greater than those of the upper- and lower-extremity motor functions.
Results date posted
| 2025 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 52 survivors of stroke (mean age, 63 years; time since stroke, 72.6 days) at Akita prefectural center for rehabilitation and psychiatric medicine. The patients had ability to walk independently for > 12 m without assistance.
Participant flow
Measurements started when participants were able to walk more than 12 m after admission to the rehabilitation unit, and were conducted three times: the baseline measurement, one month later, and two months later.
Adverse events
Nothing.
Outcome measures
Ambulatory trunk movements had been recorded by an accelerometer attached to the lower back at the L3 vertebra level. The Lissajous index (LI) calculated with the medio-lateral and vertical acceleration values was used to evaluate the trunk asymmetry during gait. A smaller LI would indicate that the gait is closer to being bilaterally symmetrical. Upper- and lower-extremity motor function, the muscle tone, lower-limb muscle strength, standing balance and trunk muscle strength were assessed the patients' physical functions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants: Patients with first-onset cerebrovascular disease (sub-acute)
Outcomes: Gait Asymmetry, Paralysis, Spasticity, Strength of trunk and lower-extremity, Balance
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062365
