UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045360 |
|---|---|
| Receipt number | R000051795 |
| Scientific Title | Characteristics of stroke patients walking on uneven terrain |
| Date of disclosure of the study information | 2021/09/23 |
| Last modified on | 2026/03/07 20:52:19 |
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Basic information
Public title
Characteristics of stroke patients walking on uneven terrain
Acronym
Characteristics of stroke patients walking on uneven terrain
Scientific Title
Characteristics of stroke patients walking on uneven terrain
Scientific Title:Acronym
Characteristics of stroke patients walking on uneven terrain
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate biomechanical parameters and muscle synergy in stroke patients compared to age-matched healthy controls during level and uneven terrain walking to identify uneven terrain-specific characteristics of gait in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
number of motor modules, fwhm
Key secondary outcomes
biomechanical parameters, muscle activity
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
Stroke patients:
1) unilateral cerebral lesions due to stroke confirmed by computed tomography or magnetic resonance imaging
2) the ability to follow verbal commands
3)Functional Independence Measure (FIM) Locomotion score more than 5
Healthy people:
1) the ability to follow verbal commands
2) community-dwelling
3) FIM Locomotion score more than 6
Key exclusion criteria
Stroke patients:
1) a history of circulatory, respiratory, and/or orthopedic problems interfering with gait
2) Mini Mental State Examination (MMSE) lower than 24 points
3) Those with severe sensory impairment
4) Those with ataxic symptoms
Healthy people:
1) History of severe orthopedic, cardiovascular, and respiratory diseases.
2) MMSE lower than 24points
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Inui |
Organization
Kio University
Division name
Department of Neurorehabilitation
Zip code
635
Address
4-2-2 Umaminaka, Koryo, Kitakatsuragi-gun, Nara
TEL
+81-745-54-1601
f1993538@kio.ac.jp
Public contact
Name of contact person
| 1st name | yasuhiro |
| Middle name | |
| Last name | inui |
Organization
Nara Prefecture General Rehabilitation Center
Division name
Department of Rehabilitation
Zip code
5450023
Address
722 Oazao, Tawaramotocho, Shiki-gun, Nara
TEL
+81-744-32-0200
Homepage URL
f1993538@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
kio 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
Nara Prefecture General Rehabilitation Center
Address
722 Oazao, Tawaramotocho, Shiki-gun, Nara
Tel
+81-744-32-0200
f1993538@kio.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 | 09 | Month | 23 | Day |
Related information
URL releasing protocol
linkinghub.elsevier.com/retrieve/pii/S0966-6362(23)00137-6
Publication of results
Published
Result
URL related to results and publications
linkinghub.elsevier.com/retrieve/pii/S0966-6362(23)00137-6
Number of participants that the trial has enrolled
40
Results
Gait speed decreased (p < 0.001) on uneven surfaces in both groups. Mediolateral RMS during swing (p < 0.001) and hip extension during stance (p = 0.023) showed interactions; post-hoc tests showed increased RMS and decreased hip extension in stroke patients on uneven surfaces. Soleus activity time during swing phase also showed an interaction (p = 0.041), with an increase observed only in stroke patients on the uneven surface.
Results date posted
| 2026 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 23 | Day |
Baseline Characteristics
Healthy controls: Age 68.2, Stroke patients: Age 68.9(Fugl-Meyer Assessment lower limb:31(4.8); Berg Balance Scale: 54(7.3))
Participant flow
Twenty patients with stroke and 20 healthy adults were enrolled in the study. All participants completed the measurements. No data were missing, and data from all 40 participants were included in the final analysis.
Adverse events
No adverse events related to this study were observed.
Outcome measures
Walking speed, root mean square of trunk acceleration, joint angles, and EMG during walking on even and uneven surfaces
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 09 | Month | 01 | Day |
Other
Other related information
Study design: Cross-sectional study
Method of recruitment of subjects: Patients in the subacute phase of hospitalization who are able to walk at a monitored level were recruited
Outcomes: biomechanical data on level and uneven terrain, muscle activity
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051795
