UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000038672
Receipt No. R000044077
Scientific Title Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Date of disclosure of the study information 2020/12/09
Last modified on 2019/11/25 (Ver. 1)

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Basic information
Public title Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Acronym Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Scientific Title Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Scientific Title:Acronym Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Region
Asia(except Japan)

Condition
Condition pre-post control
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes dynamic knee valgus

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 hip and knee strengthening/
Interventions/Control_2 hip and knee strengthening /instruction
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
18 years-old <=
Age-upper limit
32 years-old >=
Gender Male and Female
Key inclusion criteria they had anterior knee pain
for at least 3 months
reported increase pain
for 2 or more activities
These activities included
ascending and descending stairs
Key exclusion criteria neurological disorder
injury to the hip,
ankle, or
lumbosacral region
heart condition
previous surgery involving the
lower extremities
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Amir
Middle name
Last name Letafatkar
Organization kharazmi university
Division name department of corrective exercises and sport injuries
Zip code 4352763633
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 009802122258084
Email letafatkaramir@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 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 kharazmi u iversity
Address gisha bridge, jalal aleahmad , kharazmi 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
2020 Year 12 Month 09 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_rec_f5.cgi
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled 90
Results 
https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_up_rec_f5.cgi
Results date posted
2019 Year 11 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
NA
Participant flow 
NA
Adverse events 
No
Outcome measures 
NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 04 Month 04 Day
Date of IRB
2018 Year 05 Month 09 Day
Anticipated trial start date
2018 Year 06 Month 10 Day
Last follow-up date
2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 25 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044077