UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024979 |
|---|---|
| Receipt number | R000028711 |
| Scientific Title | Reliability and validity of the 2-minute walk test among spinal compression fracture patients |
| Date of disclosure of the study information | 2016/11/25 |
| Last modified on | 2019/03/14 15:37:07 |
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Basic information
Public title
Reliability and validity of the 2-minute walk test among spinal compression fracture patients
Acronym
Reliability and validity of the 2-minute walk test
Scientific Title
Reliability and validity of the 2-minute walk test among spinal compression fracture patients
Scientific Title:Acronym
Reliability and validity of the 2-minute walk test
Region
| Japan |
Condition
Condition
spinal compression fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the reliability and validity of the 2-minutes walk test among spinal compression fracture patients.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to examine the reliability and validity of the 2-minutes walk test among spinal compression fracture patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-minute walking test
Key secondary outcomes
>6-minute walking test
>HR
>Rating of Perceived Exertion scores for dyspnea and leg fatigue
>SpO2
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants included in the study had a spinal compression fracture at the thoracic, thoracolumbar or lumbar spine level. Inclusion criteria for participants were that they be 70 years of age or older, Japanese speaking, and able to ambulate at least 6 minutes without physical assistance from another person.
Key exclusion criteria
Participants were excluded from the study if they were unable to provide informed consent due to cognitive impairment, or if they had a history of disorder that neuromuscular disorder or cerebrovascular disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Goda |
Organization
Jyuzen Memorial Hosipital
Division name
Rehabilitation Center
Zip code
434-0041
Address
1700, Komatsu, Hamakitaku, Hamamatsu-shi, Shizuoka
TEL
+81-53-586-1115
12dr02@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Goda |
Organization
Jyuzen Memorial Hosipital
Division name
Rehabilitation Center
Zip code
434-0041
Address
1700, Komatsu, Hamakitaku, Hamamatsu-shi, Shizuoka
TEL
+81-53-586-1115
Homepage URL
12dr02@g.seirei.ac.jp
Sponsor or person
Institute
Jyuzen Memorial Hosipital
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
Jyuzen Memorial Hosipital
Address
1700, Komatsu, Hamakitaku, Hamamatsu-shi, Shizuoka
Tel
+81-53-586-1115
12dr02@g.seirei.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
| 2016 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 11 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 04 | Day |
Other
Other related information
Reliability and validity of the 2-minutes walk test among spinal compression fracture patients
Management information
Registered date
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028711
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
