UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047264 |
|---|---|
| Receipt number | R000053907 |
| Scientific Title | Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome |
| Date of disclosure of the study information | 2023/06/06 |
| Last modified on | 2022/03/23 16:46:40 |
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Basic information
Public title
Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Acronym
Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Scientific Title
Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Scientific Title:Acronym
Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Region
| Asia(except Japan) |
Condition
Condition
Rehabilitation
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
All narrative objectives were appropriate.
Basic objectives2
Others
Basic objectives -Others
Rehabilitation, prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS scale (pain intensity) was assessed before and after intervention
Key secondary outcomes
Knee valgus kinematic and performance were assessed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and 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
| Other |
Interventions/Control_1
Exercise plus EMS suit,
Exercises for eight weeks, three times a week, the duration of each training session was 45-60 minutes.
The training protocol consisted of 16 exercises.
Interventions/Control_2
Exercise without EMS suit,
Exercises for eight weeks, three times a week, the duration of each training session was 45-60 minutes.
The training protocol consisted of 16 exercises.
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
(1) symptoms of anterior knee pain for at least 1 month and (2) average pain level of 4 or more on a 10-cm visual analogue scale during squatting with the diagnosis of an experienced physiotherapist (3) presence of 2 of the following clinical criteria on assessment.
Key exclusion criteria
(1) 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).
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Hadi |
| Middle name | |
| Last name | Mohammadi Nia Samakosh |
Organization
Kharazmi university
Division name
Khu
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
shahramsamakosh92@yahoo
Public contact
Name of contact person
| 1st name | Hadi |
| Middle name | |
| Last name | Mohammadi Nia Samakosh |
Organization
Kharazmi university
Division name
Khu
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
https://www.linkedin.com/in/hadi-shahram-mohammadi-nia-samakosh-308091194
shahramsamakosh92@yahoo
Sponsor or person
Institute
Kharazmi university
Institute
Department
Personal name
Funding Source
Organization
Kharazmi university
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
Kharazmi university
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel
989336487376
shahramsamakosh92@yahoo
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
| 2023 | Year | 06 | Month | 06 | 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
44
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 | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 29 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053907
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