UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055853 |
|---|---|
| Receipt number | R000063834 |
| Scientific Title | The effect of real-time gait feedback by inertial measurement units in patients with stroke |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2024/10/16 17:02:22 |
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Basic information
Public title
The effect of real-time gait feedback in patients with stroke
Acronym
The effect of real-time gait feedback in patients with stroke
Scientific Title
The effect of real-time gait feedback by inertial measurement units in patients with stroke
Scientific Title:Acronym
The effect of real-time gait feedback by inertial measurement units in patients with stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify whether joint angles during gait, activity, and quality of life change by feedback of joint angles during gait in patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Joint angle during gait.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Walking exercises with feedback of hip motion during walking by IMU are performed for 10 minutes/time for a total of 8 times for 1 month.
Interventions/Control_2
Perform normal walking exercises for 10 minutes/each time for a total of 8 times for 1 month.
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
1) The ability to walk independently for at least 16m
2) Stable medical condition
3) Have a history of stroke
Key exclusion criteria
Those with cognitive decline or hearing loss that makes it difficult to complete the task.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sota |
| Middle name | |
| Last name | Araki |
Organization
Touhokufukushi university
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
989-3201
Address
6-149-1, Kunimigaoka, Aoba-Ku, Sendai
TEL
0227286028
s-araki@tfu.ac.jp
Public contact
Name of contact person
| 1st name | Sota |
| Middle name | |
| Last name | Araki |
Organization
Touhokufukushi university
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
989-3201
Address
6-149-1, Kunimigaoka, Aoba-Ku, Sendai
TEL
0227286028
Homepage URL
s-araki@tfu.ac.jp
Sponsor or person
Institute
Touhokufukushi university
Institute
Department
Personal name
Sota Araki
Funding Source
Organization
self funding
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
Touhokufukushi university
Address
6-149-1, Kunimigaoka, Aoba-Ku, Sendai
Tel
0227286028
s-araki@tfu.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 | 10 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063834
