UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031611 |
|---|---|
| Receipt number | 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 23:01:21 |
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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
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
std_alireza.derakhshani@khu.ac.ir
Sponsor or person
Institute
Kharazmi university
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036041
