UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055612 |
|---|---|
| Receipt number | R000063457 |
| Scientific Title | Exploratory study for the effect of curved carbon cane use in patients with hemiplegic stroke |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/09/20 19:25:31 |
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Basic information
Public title
Effect of curved carbon cane use in patients with hemiplegic stroke
Acronym
Effect of curved carbon cane
Scientific Title
Exploratory study for the effect of curved carbon cane use in patients with hemiplegic stroke
Scientific Title:Acronym
Exploratory study for the effect of curved carbon cane
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of curved carbon cane use in patients with hemiplegic stroke by using gait motion analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
step length
Key secondary outcomes
walking speed, cadence, walking pattern (joint angle, trajectory for center of gravity, spatial-temporal parameters)
physical function assessment (Stroke Impairment Assessment Set (SIAS), Standing test for Imbalance and DisEquilibrium (SIDE), Timed Up & Go Test (TUG), Functional Ambulation Categories (FAC)), Functional Independence Measure (FIM)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Gait exercise with a curved carbon cane for at least 20 minutes per day for 2 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hemiplegic stroke admitted to our convalescent rehabilitation ward
Key exclusion criteria
Severe cognitive impairment, bilateral motor dysfunction, brain damage limited to the cerebellum, history of a condition that may affect walking (neurological disease, spinal cord injury, severe osteoarthritis, etc.), severe visual or hearing impairment, use of a forearm-supporting cane, restriction of exercise load due to severe medical disease (myocardial infarction, heart failure, etc.), body weight over 100 kg
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka, Obu Aichi, Japan
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka, Obu Aichi, Japan
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Syupoon Inc.
Name of secondary funder(s)
Syupoon Inc.
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka, Obu Aichi, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
国立研究開発法人 国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 30 | 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 | 08 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063457
