UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035348 |
|---|---|
| Receipt number | 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 | 2021/06/18 12:31:17 |
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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
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
letafatkaramir@yahoo.com
Sponsor or person
Institute
kharazmi university
Institute
Department
Personal name
Funding Source
Organization
no 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
kharazmi uiversity
Address
tehran
Tel
982182883590
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
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040274
