Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304561563965 Date of Registration: 11/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of eccentric training on postural balance in athletes with patellar tendinopathy
Official scientific title Effect of progressive tendon-loading eccentric exercise therapy in athletes with patellar tendinopathy on postural control: a randomised clinical trial
Brief summary describing the background and objectives of the trial Patellar tendinopathy induces postural balance alterations in athletes. The impaired postural balance may increase subsequent injury risk in these athletes, which is the source of extended removal from sports participation and elevated medical cost. Therefore, it is important to enhance postural balance in athletes with patellar tendinopathy. Quadriceps strength deficits and pain, which are documented in athletes with patellar tendinopathy, are associated to postural balance. Excentric training enhances quadriceps strength and patellar tendon pain. Therefore, this training modality may decrease postural balance deficits in athletes with patellar tendinopathy. The aim of this study is to assess the effect of eccentric training on postural balance in athletes with patellar tendinopathy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2022
Actual trial start date 04/01/2022
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date 30/03/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Eccentric training Daily, with 3 sets of 15 repetitions for 12 weeks 3 months Static balance control is assessed using a force platform (PostureWin, Techno Concept, Cereste, France; 40-Hz frequency, 12-bits A/D conversion) to record the center of pressure (CoP) excursions. Dynamic balance is evaluated using the Y Balance Test. The maximal voluntary isometric contraction of the quadriceps is assessed with an isokinetic dynamometer. Patellar tendon pain is assessed using the Victorian Institute of Sports Assessment for the Patellar tendon (VISAP) questionnaire. Then, after baseline assessments, participants underwent an eccentric exercise program consisting of standing on the injured leg on a 25° decline board and slowly squat down for 12 weeks. They underwent another measurement session (follow-up) after 12 weeks. 15
Control Group no intervention 3 months At baseline, static balance control was assessed using a force platform (PostureWin, Techno Concept, Cereste, France; 40-Hz frequency, 12-bits A/D conversion) to record the center of pressure (CoP) excursions. Dynamic balance was evaluated using the Y Balance Test. The maximal voluntary isometric contraction of the quadriceps was assessed with an isokinetic dynamometer. Patellar tendon pain was assessed using the Victorian Institute of Sports Assessment for the Patellar tendon (VISAP) questionnaire. The control group didn’t do any intervention and we kept track of them through phone calls. They undergo another measurement (follow-up measurement) session after 12 weeks. 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria were as follows: -Athletes aged of 18 to 35 years -Clinical diagnosis of unilateral patellar tendinopathy conducted by an experienced sports physician: diagnosis was based mainly on clinical assessment (Malliaras et al., 2015; Owoeye et al., 2018; Rosen et al., 2021) -Participants had activity-related patellar tendon pain for at least 3 months (Lee et al., 2020) Exclusion criteria were the following: -Prior knee surgery -Corticosteroid injections for patellar tendinopathy in the last 12 months -History of lower-limb fracture -Any other coexisting knee pathology -Recovering from another lower-extremity injury -Concussions -Visual, vestibular or neurological disorders; or any other disease that may influence balance control Adult: 18 Year(s)-44 Year(s) 18 Year(s) 35 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/02/2020 committee of Protection of Persons in South
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postural balance Prior to intervention and after a 12-week follow-up period
Secondary Outcome strength, pain, proprioception and performance Prior to intervention and after a 12-week follow-up period
Secondary Outcome strength, pain, proprioception and performance Prior to intervention and after a 12-week follow-up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
medical sports center Road El Matar km 3.5 Sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Thouraya Fendri Taieb Mhiri Mahdia Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory EM2S road el Matar sfax Tunisia Laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thouraya Fendri thouraya.fendri.1@gmail.com +21627310743 Taib Mhiri
City Postal code Country Position/Affiliation
Mahdia Tunisia LR19JS01
Role Name Email Phone Street address
Public Enquiries Thouraya Fendri thouraya.fendri.1@gmail.com +21627310743 Taib Mhiri
City Postal code Country Position/Affiliation
Mahdia Tunisia LR19JS01
Role Name Email Phone Street address
Scientific Enquiries Thouraya Fendri thouraya.fendri.1@gmail.com +21627310743 Taib Mhiri
City Postal code Country Position/Affiliation
Mahdia Tunisia LR19JS01
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after identification (text, tables, figures, and appendices) Informed Consent Form 12 months following article's publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/04/2023 We a revision asking about the actual trial start date and completion date?: Authors response: We apologize for this missing. The actual start date was on January the 4th 2022 and the completion date was on march the 30th 2022. 04 Jan 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 06/04/2023 We a revision asking about the actual trial start date and completion date?: Authors response: We apologize for this missing. The actual start date was on January the 4th 2022 and the completion date was on march the 30th 2022. 30 Mar 2022
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 06/04/2023 Reviewer's comment: Please enter each inclusion and exclusion criterion in its own line. Authors' response: We thank the reviewer for the comment and we changed the inclusion and exclusion criterion to put each one in its own line. Inclusion criteria were as follows: athletes aged of 18 to 35 years (Breda et al., 2021) and clinical diagnosis of unilateral PT by an experienced sports physician. PT diagnosis was based mainly on clinical assessment (Malliaras et al., 2015; Owoeye et al., 2018; Rosen et al., 2021). Participants had activity-related patellar tendon pain for at least 3 months (Lee et al., 2020). Inclusion criteria were as follows: -Athletes aged of 18 to 35 years -Clinical diagnosis of unilateral patellar tendinopathy conducted by an experienced sports physician: diagnosis was based mainly on clinical assessment (Malliaras et al., 2015; Owoeye et al., 2018; Rosen et al., 2021) -Participants had activity-related patellar tendon pain for at least 3 months (Lee et al., 2020)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/04/2023 Reviewer's comment: Please enter each inclusion and exclusion criterion in its own line. Authors' response: We thank the reviewer for the comment and we changed the inclusion and exclusion criterion to put each one in its own line. Exclusion criteria were the following: prior knee surgery; corticosteroid injections for PT in the last 12 months; history of lower-limb fracture; any other coexisting knee pathology; recovering from another lower-extremity injury; concussions; visual, vestibular or neurological disorders; or any other disease that may influence balance control. Exclusion criteria were the following: -Prior knee surgery -Corticosteroid injections for patellar tendinopathy in the last 12 months -History of lower-limb fracture -Any other coexisting knee pathology -Recovering from another lower-extremity injury -Concussions -Visual, vestibular or neurological disorders; or any other disease that may influence balance control
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 31/03/2026 PACTR Admin Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/04/2023 We received a comment asking why is the description for both groups the same, please clarify. Authors response: -The description was the same for the conducted measurements only (at baseline and at follow-up: after 12 weeks): static balance control assessment, dynamic postural control assessment, maximal voluntary isometric contraction of the quadriceps, patellar tendon pain assessment. However, the intervention was not the same. The control group didn’t do any intervention. Then, after 12 weeks, the follow-up measurements were conducted. However, the experimental group underwent an eccentric exercise program consisting of standing on the injured leg on a 25° decline board and slowly squat down for 12 weeks. After 12 weeks of eccentric training, they underwent another measurement session. In order to clarify that, more details have been added to the intervention description for both groups. Experimental Group, Eccentric training, Daily, with 3 sets of 15 repetitions for 12 weeks , 3 months, Static balance control is assessed using a force platform (PostureWin, Techno Concept, Cereste, France; 40-Hz frequency, 12-bits A/D conversion) to record the center of pressure (CoP) excursions. Dynamic balance is evaluated using the Y Balance Test. The maximal voluntary isometric contraction of the quadriceps is assessed with an isokinetic dynamometer. Patellar tendon pain is assessed using the Victorian Institute of Sports Assessment for the Patellar tendon (VISAP) questionnaire. Then, participants undergo an eccentric exercise program consisting of standing on the injured leg on a 25° decline board and slowly squat down. They undergo another measurement session after 12 weeks., 15, Experimental Group, Eccentric training, Daily, with 3 sets of 15 repetitions for 12 weeks , 3 months, Static balance control is assessed using a force platform (PostureWin, Techno Concept, Cereste, France; 40-Hz frequency, 12-bits A/D conversion) to record the center of pressure (CoP) excursions. Dynamic balance is evaluated using the Y Balance Test. The maximal voluntary isometric contraction of the quadriceps is assessed with an isokinetic dynamometer. Patellar tendon pain is assessed using the Victorian Institute of Sports Assessment for the Patellar tendon (VISAP) questionnaire. Then, after baseline assessments, participants underwent an eccentric exercise program consisting of standing on the injured leg on a 25° decline board and slowly squat down for 12 weeks. They underwent another measurement session (follow-up) after 12 weeks., 15,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/04/2023 Reviewer comment: Why is the description for both groups the same, please clarify Authors response: -The description was the same for the conducted measurements only (static balance control assessment, dynamic postural control assessment, maximal voluntary isometric contraction of the quadriceps, patellar tendon pain assessment) at baseline and at follow-up (after 12 weeks). However, the intervention was not the same. The control group didn’t do any intervention. Then, after 12 weeks, the follow-up measurements were conducted. However, the experimental group underwent an eccentric exercise program consisting of standing on the injured leg on a 25° decline board and slowly squat down. After 12 weeks of eccentric training, they underwent another measurement session. In order to clarify that, the following sentence was added to the intervention description of the control group: "The control group didn’t do any intervention." Control Group, no intervention, , 3 months, Static balance control assessed using a force platform (PostureWin, Techno Concept, Cereste, France; 40-Hz frequency, 12-bits A/D conversion) to record the center of pressure (CoP) excursions. Dynamic balance was evaluated using the Y Balance Test. The maximal voluntary isometric contraction of the quadriceps assessed with an isokinetic dynamometer. Patellar tendon pain was assessed using the Victorian Institute of Sports Assessment for the Patellar tendon (VISAP) questionnaire. Then, we will keep track of them through phone calls. They will undergo another measurement session after 12 weeks. , 15, Uncontrolled Control Group, no intervention, , 3 months, At baseline, static balance control was assessed using a force platform (PostureWin, Techno Concept, Cereste, France; 40-Hz frequency, 12-bits A/D conversion) to record the center of pressure (CoP) excursions. Dynamic balance was evaluated using the Y Balance Test. The maximal voluntary isometric contraction of the quadriceps was assessed with an isokinetic dynamometer. Patellar tendon pain was assessed using the Victorian Institute of Sports Assessment for the Patellar tendon (VISAP) questionnaire. The control group didn’t do any intervention and we kept track of them through phone calls. They undergo another measurement (follow-up measurement) session after 12 weeks. , 15, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 13/12/2025 We forgot to put some secondary outcomes Secondary Outcome, strength and pain, Prior to intervention and after a 12-week follow-up period Secondary Outcome, strength, pain, proprioception and performance, Prior to intervention and after a 12-week follow-up period
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/04/2023 PACTR Admin TRUE, committee of Protection of Persons in South, Road Manzel Cheker, Sfax, 3029, Tunisia, , 08 Feb 2020, +21671783828, thouraya.fendri.1@gmail.com, 25421_24245_4737.pdf TRUE, committee of Protection of Persons in South, Road Manzel Cheker, Sfax, 3029, Tunisia, , 08 Feb 2020, +21671783828, thouraya.fendri.1@gmail.com, 25421_24245_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/04/2023 reveiewer's comment: Why is the ethics email addressed to an individual, please revise. Autors' response: A mistake was made during data entry. We apologize for this mistake and we revised it. TRUE, committee of Protection of Persons in South, Road Manzel Cheker, Sfax, 3029, Tunisia, , 08 Feb 2020, +21671783828, thouraya.fendri.1@gmail.com, 25421_24245_4737.pdf TRUE, committee of Protection of Persons in South, Road Manzel Cheker, Sfax, 3029, Tunisia, , 08 Feb 2020, +21671783828, cnem@rns.tn, 25421_24245_4737.pdf