UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019380 |
|---|---|
| Receipt number | R000022410 |
| Scientific Title | The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2017/04/17 11:00:51 |
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Basic information
Public title
The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients
Acronym
The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients
Scientific Title
The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients
Scientific Title:Acronym
The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The stroke patients that are outdoor walking as a subject in the lower limbs brace and t-shaped cane in everyday life, a total of gait training (1 day at the slow speed of 1 hour per day using a conventional t-shaped cane and Nordic pole the number of steps is 5000 steps the target) three times a week, the difference between the effect of a total of 8 weeks of gait training, are evaluated by the 6-minute walk test, which was fitted with a portable breath gas analyzer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After 8 weeks training,
pain and numbness of the hand using the visual analogue scale, average walking speed, walking distance, number of steps, average heart rate and average V02/body weight/min of 6 minutes walking test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the t-cane, three times a week, one hour per day, is performed a total of 8 weeks of training.
They use a t-cane in everyday life during walking.
Interventions/Control_2
Using the Nordic pole, three times a week, one hour per day, is performed a total of 8 weeks of training.
They use the Nordic pole in everyday life during walking.
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
stroke patients who usually use the lower extremity brace and t-shaped cane in everyday life by doing an outdoor walking, the severity of the paralysis of the lower limbs is Brunnstrom stage 3, 4.
Key exclusion criteria
Patients who suffers from walking due to cardiopulmonary or musculoskeletal diseases.
Patients who take a medicine that affect the exercise stress.
Patients participating in other clinical research within registered 28 days prior to.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Takahashi |
Organization
Saitama medical university international center
Division name
rehabilitation medicine
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
+81-422-984-4111
taka1959@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Takahashi |
Organization
Saitama medical university international center
Division name
rehabilitation medicine
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
+81-422-984-4111
Homepage URL
taka1959@saitama-med.ac.jp
Sponsor or person
Institute
Hidetoshi Takahashi
Institute
Department
Personal name
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
Address
Tel
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
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | 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
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022410
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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