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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031611
Receipt No. R000036041
Scientific Title Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome
Date of disclosure of the study information 2018/05/09
Last modified on 2018/05/09

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Basic information
Public title Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome
Acronym The effects of Sensorimotor training programs in patients with Scapular Downward Rotation Syndrome
Scientific Title Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome
Scientific Title:Acronym The effects of Sensorimotor training programs in patients with Scapular Downward Rotation Syndrome
Region
Asia(except Japan)

Condition
Condition Scapular Downward Rotation Syndrome
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the effects of six weeks sensorimotor training and sensorimotor plus passive interventions program on pain, electrical activity of selected scapular muscles and kinematics in people with scapular downward rotation syndrome (SDRS)
Basic objectives2 Others
Basic objectives -Others To evaluate the differences between intervention programs
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain, electrical activity of selected scapular muscles and kinematics.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervention 1: 6-week sensorimotor training program; 3 sessions per week (1 hour each session
Interventions/Control_2 Intervention 2: 6-week sensorimotor plus Passive Interventions program; 3 sessions per week (1 hour each session)
Interventions/Control_3 Control group; total of 3 hours per week home exercise program described postural correction on daily activities.
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
27 years-old >=
Gender Male
Key inclusion criteria The inclusion criteria were: (1) the downwardly rotated scapula (the inferior angle moves medially, and the glenoid fossa rotates to face caudally); (2) the acromioclavicular joint lower than the sternoclavicular joint; (3) the vertebral border of the scapula less than 3 inches from the spine with tape measure (measured from the midpoint of the vertebral border of the scapula to the corresponding thoracic spinous process); (4) previous history of neck pain at least for 6 weeks; and (5) VAS score at rest between 3 and 7 (severe pain).
Key exclusion criteria Subjects with cervical spinal fractures, neck rotation ROM of < 20 degrees, radiating pain to the upper extremity, history of unresolved cancer, neurological disorders and subjects with severe musculoskeletal disorders were excluded. Subjects were also excluded if they missed practice for three consecutive sessions or more due to neck or shoulder pain.
Target sample size 132

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Amir Letafatkar
Organization Kharazmi University
Division name Faculty of Physical Education and Sport Sciences
Zip code
Address Faculty of Physical Education, Kharazmi University, South Hesari St., Mirdamad Blvd., Tehran
TEL 00989357365993
Email amir.letafatkar@khu.ac.ir

Public contact
Name of contact person
1st name
Middle name
Last name Alireza Derakhshani
Organization Kharazmi University
Division name Faculty of Physical Education and Sport Sciences
Zip code
Address Faculty of Physical Education, Kharazmi University, South Hesari St., Mirdamad Blvd., Tehran
TEL 00989364331192
Homepage URL
Email std_alireza.derakhshani@khu.ac.ir

Sponsor
Institute Kharazmi university
Institute
Department

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
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
2018 Year 05 Month 09 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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2018 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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