UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034807 |
|---|---|
| Receipt number | R000039696 |
| Scientific Title | The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis |
| Date of disclosure of the study information | 2018/12/31 |
| Last modified on | 2023/12/27 06:53:34 |
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Basic information
Public title
The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Acronym
The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Scientific Title
The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Scientific Title:Acronym
The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Region
| Japan |
Condition
Condition
Patients with hemiparesis due to stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between gait adaptability and physical activity or fall risk in patients with hemiparesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Giat speed, number of falls during 6-month, step count per day
Key secondary outcomes
Kinematic and kinetic data during gait
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) community-dwelling
4) Functional Independence Measure (FIM) Locomotion score more than 6
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) Stroke Impairment Assessment Set (SIAS) Visuospatial item lower than 2
4) SIAS Speech item lower than 1B
Healthy people:
1) MMSE lower than 24points
2) SIAS Visuospatial item lower than 2
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Shin-Ichi |
Organization
Tohoku University
Division name
Department of Physical Medicine and Rehabilitation
Zip code
9800872
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Honda |
Organization
Tohoku University Hospital
Division name
Department of Rehabilitation
Zip code
9808574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7677
Homepage URL
keita.honda.d2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2018 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039696
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fnhum.2021.762223/full
Number of participants that the trial has enrolled
26
Results
Walking activity significantly and positively correlated with the difference in paretic step length under the conditions of different surface properties in the poststroke patients (r = 0.65, p = 0.012) and step width in the healthy controls (r = 0.68, p = 0.015).
Results date posted
| 2023 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
14 hemiparesis after stroke (age:59.4, SD8.9 years; post-onset duration:70.7, SD53.5 months), 12 healthy controls (age:59.5, SD14.2 years)
Participant flow
For the uneven surface, the study used an artificial grass surface (7 m long, 2-cm leaf length). The subjects repeated even surface walking and the uneven surface walking trials at least two times at a comfortable speed. We collected spatiotemporal and kinematic gait parameters on both the even and uneven surfaces using a three-dimensional motion analysis system. After we measured gait, the subjects wore an accelerometer around the waist for at least 4 days. We measured the number of steps per day using the accelerometer to evaluate walking activity.
Adverse events
None
Outcome measures
gait parameters, walking activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: Prospective cohort study
Recruitment Methods: Poster in tohoku university and hospital
Outcomes: Gait data in the even and uneven ground, number of falls during 6-months, step counts per day
Management information
Registered date
| 2018 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039696
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