UMIN-CTR Clinical Trial

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
Email	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
Email	amir.letafatkar@khu.ac.ir

Sponsor
Institute	kharazmi university
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039062