UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050379 |
|---|---|
| Receipt number | R000057365 |
| Scientific Title | Gait Analysis of Unilateral Nordic Pole and T-cane with Focus on Trunk Function in Stroke Hemiplegic Patients |
| Date of disclosure of the study information | 2023/02/18 |
| Last modified on | 2024/02/19 22:11:33 |
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Basic information
Public title
Gait analysis of long cane vs. single cane focusing on trunk function in stroke hemiplegic patients
Acronym
Gait analysis of long cane vs. single cane focusing on trunk function in stroke hemiplegic patients
Scientific Title
Gait Analysis of Unilateral Nordic Pole and T-cane with Focus on Trunk Function in Stroke Hemiplegic Patients
Scientific Title:Acronym
Gait Analysis of Unilateral Nordic Pole and T-cane with Focus on Trunk Function in Stroke Hemiplegic Patients
Region
| Japan |
Condition
Condition
Cerebrovascular disease (stroke)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare gait with unilateral Nordic Pole and gait with T-cane (single cane) in stroke paraplegic patients from kinematic and kinetic indices using a three-dimensional motion analyzer to clarify differences in trunk movement and general body movements during gait
Basic objectives2
Others
Basic objectives -Others
Kinematics and kinematics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absolute and relative trunk angles (flexion/extension/lateral bending/rotation) while walking
Pelvic angle during gait (forward/backward tilt/tilt/rotation)
Key secondary outcomes
Floor reaction force (vertical/forward/backward/left-right components, vertical component of cane/pole reaction force)
Center of gravity: COG (vertical/horizontal movement amplitude)
Lower limb joint moments (hip flexion/extension/adduction/adternal rotation/extension, knee flexion/extension, ankle plantar flexion/dorsiflexion)
Lower limb joint angles (hip flexion/extension/adternal abduction/adternal external rotation, knee flexion/extension, ankle plantar flexion/dorsiflexion)
Time-distance factor (stride length/step distance/walking speed, single-leg support phase time/load response phase time/pre-leg walking phase time, walking phase time)
Translated with www.DeepL.com/Translator (free version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Unilateral Nordic Pole gait training(2 weeks: physiotherapist rehabilitation time, T-cane independent patients use Nordic Pole in the ward if permission is granted)
Interventions/Control_2
T-cane gait training(2 weeks: physiotherapist rehabilitation time, T-cane independent patients continue to use T-cane in the ward)
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke patients in recovery phase (within 180 days of onset)
Brunnstrom Recovery Stage III/IV of the paralyzed lower extremity
Gait independence from proximal monitoring to independent level
Those using a T-cane(single cane)in everyday(ward life)and rehabilitation situations.
Those deemed by the attending physician to be safe to participate in the study
Key exclusion criteria
Those with severe higher brain dysfunction and difficulty in understanding verbal instructions.
(Those who score less than 5 on the Functional Independence Measure (FIM) cognitive items of expression, comprehension, social interaction, and problem solving, and less than 4 on the memory item.
(Those who score less than 5 points in expression, comprehension, social interaction, and problem solving, and less than 4 points in memory on the Functional Independence Measure: FIM)
Patients with complications that affect walking due to orthopedic diseases.
Translated with www.DeepL.com/Translator (free version)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
International University of Health and Welfare, Graduate School
Division name
Welfare Support Engineering
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo 107-8402
TEL
03-5574-3874
sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ishikawa |
Organization
Naka Izu Rehabilitation Center
Division name
Department of Physical Therapy
Zip code
410-2507
Address
1523-108, hiekawa, Izu-city, Shizuoka 410-2507, Japan
TEL
0558-83-2111
Homepage URL
22s3002@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Graduate School
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare, Graduate School
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
International University of Health and Welfare, Graduate School
Address
Akasaka, Minato-ku, Tokyo 107-8402
Tel
03-5574-3874
sumiko-y@iuhw.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
| 2023 | Year | 02 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 02 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057365
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| Registered date | File name |
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