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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000047921
Receipt No. R000054632
Scientific Title Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Date of disclosure of the study information 2022/06/02
Last modified on 2022/06/01

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Basic information
Public title Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Acronym Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Scientific Title Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Scientific Title:Acronym Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Region
Asia(except Japan)

Condition
Condition pretesr-posttest
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain
Disability
Key secondary outcomes Single-Leg Landing Task (Kinematic)
Single Leg Hop Test

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 exercise with EMS
Interventions/Control_2 exercise without EMS
Interventions/Control_3
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
30 years-old >=
Gender Male and Female
Key inclusion criteria symptoms of anterior knee pain for at least one month; (2) average pain level of four or more on a 10-cm visual analogue scale during squatting; and (3) presence of two of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test and completing the consent form
Key exclusion criteria any history of knee surgery; (2) history of patellar dislocation or subluxation or ligament laxity; (3) orthopedic and nerve injuries; (4) history of other abnormalities such as leg length inequalities (> 2 cm); and (5) medication as a part of the treatment 50. Participants were also excluded from the study if they underwent other types of therapy, specific work activities, or regular treatments (e.g., stretching, tape, braces, orthoses and/or acupuncture) or if they failed in two consecutive sessions or three non-consecutive sessions, n = 1 male) or if they failed in the post-test phase (n = 1 male)
Target sample size 44

Research contact person
Name of lead principal investigator
1st name amir
Middle name
Last name letafatkar
Organization Kharazmi Univrsity
Division name Sport medicine
Zip code 6664743
Address tehran
TEL 00989195394692
Email letafatkaramir@yahoo.com

Public contact
Name of contact person
1st name amir
Middle name
Last name letafatkar
Organization Kharazmi University
Division name sport medicine
Zip code 6664743
Address tehran
TEL 00989357465993
Homepage URL
Email letafatkaramir@yahoo.com

Sponsor
Institute "NO"
Institute
Department

Funding Source
Organization 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 Ethics Committee of the Polytechnic Institute of Santarem, Portugal (N6-2022ESDRM)
Address Portugal
Tel 2322 7250
Email rafaeloliveira@esdrm.ipsantarem.pt

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
2022 Year 06 Month 02 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 42
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
2021 Year 02 Month 02 Day
Date of IRB
2021 Year 09 Month 02 Day
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 01 Day
Last modified on
2022 Year 06 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054632

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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