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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035348
Receipt No. R000040274
Scientific Title Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Date of disclosure of the study information 2019/07/10
Last modified on 2019/08/04

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Basic information
Public title Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Acronym Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Scientific Title Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Scientific Title:Acronym Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Region
Asia(except Japan)

Condition
Condition pre to post-intervention
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Basic objectives2 Others
Basic objectives -Others comparison the effect of corrective exercises with and without taping on pain, Electromyography, kinematics and muscle strength in female badminton players with scapular dyskinesia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes function-DASH score
kinematics
Penn Shoulder Score (Total, Pain, Satisfaction, and Function)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Medicine
Interventions/Control_1 Therapeutic Exercise with taping
Interventions/Control_2 Therapeutic Exercise alone
Interventions/Control_3 control: placebo
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
18 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria Participants were eligible for this study if they had SD based on observational examination and a positive scapular assistance test or reposition test, to ensure the SIS symptoms were related to SD.
Key exclusion criteria Participants were excluded if they had a history of surgery, fracture, or dislocation and traumatic onset of shoulder pain; existence of type 3 acromion; massive rotator cuff tear; a long head of bicep tendon tear; or degenerative joint disorder at the shoulder complex, any rheumatologic, systemic, or neurologic disorders; any neuro-musculoskeletal disorder (including cervical radiculopathy); a body mass index >30kg/m2; being pregnant, and, receiving steroid injections and physical therapy during the previous 6 months before the study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Sarvenaz
Middle name
Last name Kazemipour
Organization Kharazmi university
Division name department of biomechanics and sport injuries
Zip code 4352763633
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 009802122258084
Email kazempour.sarvenaz@yahoo.com

Public contact
Name of contact person
1st name amir
Middle name
Last name letafatkar
Organization kharazmi University
Division name department of biomechanics and sport injuries
Zip code 4353663663
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00989195394692
Homepage URL
Email letafatkaramir@yahoo.com

Sponsor
Institute kharazmi university
Institute
Department

Funding Source
Organization kharazmi university
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 kharazmi u iversity
Address gisha bridge, jalal aleahmad , tarbiatmodares university,tehran
Tel 982182883590
Email healthcontrol@kharazmi.ac.ir

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 07 Month 10 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 170
Results
Results date posted
Results Delayed
Results Delay Reason we are submission process to journalals
Date of the first journal publication of results
Baseline Characteristics
	TE+KT (n=40)	TE alone (n=40)	Control (n=40)	P value
Age, years; mean (SD)	35.4 (4.4)	40.5 (5.5)	37.5 (6.3)	0.209
Weight, kg; mean (SD)	76.1 (5.3)	73.7 (7.2)	69.4 (8.1)	0.398
Gender - female; n (%)	20 (50)	22 (55)	21 (52.5)	0.522
Arm Dominance - dominant; n (%)	11 (55)	12 (60)	12 (60)	0.528
Duration of symptoms; n (%)	-	-	-	-
6-12 weeks	14 (35)	14 (35)	13 (32.5)	0.675
Greater than 12 weeks	26 (65)	26 (65)	27 (67.5)	0.648
Participant flow
Adverse events
No significant adverse events were reported during the study. Subjects were advised to perform the exercises as long as they felt no pain or soreness. Some of the subjects (three in group 1 and four in group 2) experienced fatigue or self-limited soreness and required longer periods of rest between exercise repetitions, subsequently duration of exercise sessions was longer than stated at the outset and in some cases total dose of exercise prescription was not achieved during the first two weeks of the treatment.
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
2018 Year 08 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 20 Day
Last follow-up date
2019 Year 05 Month 10 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 12 Month 23 Day
Last modified on
2019 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040274

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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