UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034262 |
|---|---|
| Receipt number | R000039062 |
| Scientific Title | Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain |
| Date of disclosure of the study information | 2019/05/06 |
| Last modified on | 2019/07/26 07:04:20 |
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Basic information
Public title
Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain
Acronym
Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain
Scientific Title
Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain
Scientific Title:Acronym
Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain
Region
| Asia(except Japan) |
Condition
Condition
university labratory
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain
Basic objectives2
Others
Basic objectives -Others
Comparison the effect of cognitive functional training with and without Movement System Impairment-Based Classification Treatment on functional status and gait mechanic in pations with nonspecific chronic low back pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain
Key secondary outcomes
disability, gait
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cognitive functional training(cft)According to this protocol, the person performed exercises each week in accordance with the program provided by the researchers. Based on this protocol, they carried out the above mentioned exercises for30 to 60minutes for 8 weeks , and the inter-set and inter-repetition rest time was adjusted at 1:3 and 1:1, respectively.
Interventions/Control_2
movment system impairment( MSI)
According to this protocol, the person performed exercises each week in accordance with the program provided by the researchers. Based on this protocol, they carried out the above mentioned exercises for 60 minutes for 8 weeks, and the inter-set and inter-repetition rest time was adjusted at 1:3 and 1:1, respectively.
Interventions/Control_3
control
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
age of 25-30 years old,
having low back pain more than 3 month.
Key exclusion criteria
neurological disease, major visual deficits, true leg-length discrepancy greater than 2 cm, and history of ankylosing spondylosis, disc herniation, tumor, infection or fracture, cauda equina syndrome, spine-fusion surgery, or any lower extremity orthopedic surgery within 1 year of the beginning of the study
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | sahar nazary soltan ahmad |
Organization
kharazmi University
Division name
department of biomechanics and sport injuries
Zip code
Address
tehran-mirdamad-sout razan street, faculty of PE
TEL
00989195394692
letafatkaramir@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | amir letafatkar |
Organization
kharazmi University
Division name
department of biomechanics and sport injuries
Zip code
Address
tehran-mirdamad-sout razan street, faculty of PE
TEL
00989195394692
Homepage URL
amir.letafatkar@khu.ac.ir
Sponsor or person
Institute
kharazmi university
Institute
Department
Personal name
Funding Source
Organization
author self funding
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
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 06 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039062
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| Registered date | File name |
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