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.: PACTR202405620806243 Date of Approval: 13/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Posterior ankle pain in South African ballet dancers
Official scientific title Posterior ankle pain in South African ballet dancers
Brief summary describing the background and objectives of the trial A dancer’s ankle, specifically the posterior ankle, is one of the areas most frequently affected by injury. Dancers are commonly diagnosed with posterior ankle pain conditions such as PAIS and FHL pathologies. Due to the possible links between posterior ankle pain and chronic load, PAIS and posterior ankle pain conditions may be well-suited to an injury prevention approach. The Australian Ballet’s Artistic Health team developed a context-informed injury prevention programme that may have accounted for the reduced incidence of ankle pain and injury recorded in their professional ballet cohort. This injury prevention programme has, however, not been tested formally. By applying the core components of this injury prevention programme (IPP) in an adolescent dancer population, the risk of developing ankle pain in these dancers may also be reduced. Study design: FEASIBILITY STUDY (A single-blinded, non-randomised cluster pilot feasibility study) (No suitable option was available at the drop-down menu below.) Main aim: Determine the feasibility of an ankle IPP for adolescent ballet dancers. Primary objectives Determine the: • Adherence to injury surveillance by adolescent ballet dancers • Adherence to the ankle IPP by the adolescent ballet dancers • Fidelity of the ankle IPP by the ballet teachers • Acceptability of and satisfaction with the ankle IPP (including injury surveillance) amongst adolescent ballet dancers and ballet teachers • Safety of the ankle IPP Secondary objectives • Report on the injuries sustained by adolescent ballet dancers • Determine the calf muscle endurance of adolescent ballet dancers before and after the intervention • Determine the range of movement of the ankle and first metatarsophalangeal joint of the adolescent ballet dancers before and after the intervention • Determine the self-reported function of the adolescent ballet dancers • Determine the presence of self-reported ankle instability in adolescent ballet dancers
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ankle pain/ injury
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/09/2023
Actual trial start date 02/09/2023
Anticipated date of last follow up 11/12/2023
Actual Last follow-up date 11/12/2023
Anticipated target sample size (number of participants) 63
Actual target sample size (number of participants) 54
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Health Sciences Research Ethics Committee of the University of the Free State- Full approval number: UFS-HSD2022/0301/2607
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Supported intervention Participants allocated to this group were instructed to perform the exercises daily. Follow-up visits to the ballet schools by the primary investigator were conducted on a weekly basis for the first two weeks of the study and thereafter every second week. Participants were 16 dancers from 4 dance schools (therefore 4 dance teachers). 12 weeks The intervention consisted of 2 exercises and some advice. The following elements were included: heel raise exercises, intrinsic foot muscle exercises, advice on icing and wearing toe spacer (if applicable to the individual participant). Participants received training on the programme as well as access to an electronic resource which contained videos and descriptions of each of the intervention elements. Participants also received the equipment (e.g., a theraband) needed to perform the exercises and apply the advice. In addition to the above, the primary investigator visited the ballet schools allocated to this group on a weekly basis for the first two weeks of the study and thereafter every second week for the remainder of the study. 20
Experimental Group Unsupported intervention Participants allocated to this group was instructed to complete the exercises daily. No follow-up visits by the primary investigator were conducted. Participants included: 18 dancers from 2 dance schools (therefore 2 dance teachers) 12 weeks The intervention consisted of 2 exercises and some advice. The following elements were included: heel raise exercises, intrinsic foot muscle exercises, advice on icing and wearing toe spacer (if applicable to the individual participant). Participants received training on the programme as well as access to an electronic resource which contained videos and descriptions of each of the intervention elements. Participants also received the equipment (e.g., a theraband) needed to perform the exercises and apply the advice. 20
Control Group Control group Not applicable. Participants allocated to this group did not receive any intervention. Participants: 13 participants from 1 ballet school (therefore 1 dance teacher) 12 weeks Participants allocated to the control group did not receive any interventions. They continued with their normal dance classes and activities. The completed the weekly injury surveillance monitoring, but did not report on adherence to any exercises. At "Nature of control" a suitable option was not available - The participants did not receive any intervention during the study period. 14 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescent dancers:  Dancers between the ages of 10 and 19 years.  Dancers enrolled at dance schools offering ballet classes on a recreational or preprofessional basis in central South Africa.  Dancers taking part in at least one ballet class per week during a typical dancing week. Dancers will be included in the study even if ballet is not the only form of dance or sport that they take part in.  Dancers participating in ballet classes for at least two years prior to enrolment into the study. Ballet teachers: Ballet teachers teaching recreational and/or pre-professional ballet classes in central South Africa. Ballet teachers will be included even if ballet is not the only form of dancing that they teach. Adolescent dancers:  Dancers who are unable/ unwilling to participate in the study.  Dancers unable to participate in a lower limb exercise programme due to pain or injury.  Dancers not currently participating in ballet classes due to injury or illness. Ballet teachers:  Ballet teachers teaching only other forms of dance e.g. tap dancing, hip hop, etc.  Ballet teachers who are unable/ unwilling to participate in the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 80 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 04/07/2022 Health Sciences Research Ethics Committee HSREC of the University of the Free State
Ethics Committee Address
Street address City Postal code Country
University of the Free State, Bloemfontein campus Bloemfontein 9301 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to injury surveillance by adolescent ballet dancers Adherence to the ankle injury prevention programme by the adolescent ballet dancers Fidelity of the ankle injury prevention programme by the ballet teachers, Acceptability of and satisfaction with the ankle injury prevention programme (including injury surveillance) amongst adolescent ballet dancers and ballet teachers Safety of the ankle injury prevention programme Adherence: Weekly. Safety: Throughout the study. Fidelity, acceptability and satisfaction: At the end of the 12 week period.
Secondary Outcome Number of injuries sustained by adolescent ballet dancers Calf muscle endurance of adolescent ballet dancers before and after the intervention Range of movement of the ankle and first metatarsophalangeal joint of the adolescent ballet dancers before and after the intervention Self-reported function of the adolescent ballet dancers Presence of self-reported ankle instability in adolescent ballet dancers Number of injuries: Weekly. Other outcomes: At beginning of the study as well as after the 12 week study period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of the Free State CR de Wet-Bophelong building, UFS, Bloemfontein Campus Bloemfontein South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Staff study support grant from the University of the Free State University of the Free State, Bloemfontein campus Bloemfontein South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None NA NA NA South Africa No sponsor
COLLABORATORS
Name Street address City Postal code Country
Professor Roline Barnes University of the Free State Bloemfontein South Africa
Dr Katia Ferrar Flinders Centre for Innovation in Cancer Adelaide Australia
Dr Sue Mayes The Australian Ballet Melbourne Australia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cherezane Stander MaraisC2@ufs.ac.za 27514017895 University of the Free State, Bloemfontein Campus
City Postal code Country Position/Affiliation
Bloemfontein 9301 South Africa Lecturer
Role Name Email Phone Street address
Public Enquiries Cherezane Stander MaraisC2@ufs.ac.za 27514017895 University of the Free State, Bloemfontein Campus
City Postal code Country Position/Affiliation
Bloemfontein 9301 South Africa Lecturer
Role Name Email Phone Street address
Scientific Enquiries Cherezane Stander MaraisC2@ufs.ac.za 27514017895 University of the Free State, Bloemfontein Campus
City Postal code Country Position/Affiliation
Bloemfontein 9301 South Africa Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes According the HSREC of the University of the Free State guidelines, individual participant data may not be shared. De-identified data was shared only with the biostatistician at the University of the Free State for analysis. A summary of results will be uploaded when available. Informed Consent Form Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable Yes 20/11/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/11/2024
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 Trial description 04/05/2024 Reviewer requested background information to be added. Study design: FEASIBILITY STUDY (A single-blinded, non-randomised cluster pilot feasibility study) (No suitable option was available at the drop-down menu below.) Main aim: Determine the feasibility of an ankle injury prevention programme for adolescent ballet dancers. Primary objectives  Determine the adherence to injury surveillance by adolescent ballet dancers  Determine the adherence to the ankle injury prevention programme by the adolescent ballet dancers  Determine the fidelity of the ankle injury prevention programme by the ballet teachers  Determine the acceptability of and satisfaction with the ankle injury prevention programme (including injury surveillance) amongst adolescent ballet dancers and ballet teachers  Determine the safety of the ankle injury prevention programme Secondary objectives  Report on the injuries sustained by adolescent ballet dancers  Determine the calf muscle endurance of adolescent ballet dancers before and after the intervention  Determine the range of movement of the ankle and first metatarsophalangeal joint of the adolescent ballet dancers before and after the intervention  Determine the self-reported function of the adolescent ballet dancers  Determine the presence of self-reported ankle instability in adolescent ballet dancers A dancer’s ankle, specifically the posterior ankle, is one of the areas most frequently affected by injury. Dancers are commonly diagnosed with posterior ankle pain conditions such as PAIS and FHL pathologies. Due to the possible links between posterior ankle pain and chronic load, PAIS and posterior ankle pain conditions may be well-suited to an injury prevention approach. The Australian Ballet’s Artistic Health team developed a context-informed injury prevention programme that may have accounted for the reduced incidence of ankle pain and injury recorded in their professional ballet cohort. This injury prevention programme has, however, not been tested formally. By applying the core components of this injury prevention programme (IPP) in an adolescent dancer population, the risk of developing ankle pain in these dancers may also be reduced. Study design: FEASIBILITY STUDY (A single-blinded, non-randomised cluster pilot feasibility study) (No suitable option was available at the drop-down menu below.) Main aim: Determine the feasibility of an ankle IPP for adolescent ballet dancers. Primary objectives Determine the: • Adherence to injury surveillance by adolescent ballet dancers • Adherence to the ankle IPP by the adolescent ballet dancers • Fidelity of the ankle IPP by the ballet teachers • Acceptability of and satisfaction with the ankle IPP (including injury surveillance) amongst adolescent ballet dancers and ballet teachers • Safety of the ankle IPP Secondary objectives • Report on the injuries sustained by adolescent ballet dancers • Determine the calf muscle endurance of adolescent ballet dancers before and after the intervention • Determine the range of movement of the ankle and first metatarsophalangeal joint of the adolescent ballet dancers before and after the intervention • Determine the self-reported function of the adolescent ballet dancers • Determine the presence of self-reported ankle instability in adolescent ballet dancers
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 04/05/2024 The information was added after discussion with the study supervisor based on the reviewers comments. According the HSREC of the University of the Free State guidelines, individual participant data may not be shared. De-identified data was shared only with the biostatistician at the University of the Free State for analysis. As this study forms part of a PhD project, no summary of results or links may be provided until the degree has been conferred. According the HSREC of the University of the Free State guidelines, individual participant data may not be shared. De-identified data was shared only with the biostatistician at the University of the Free State for analysis. A summary of results will be uploaded when available.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 20/11/2024 The registry requires a summary of the results within 12 months after trial completion. No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 20/11/2024 The registry requires a summary of the results within 12 months after trial completion. 30465_21085_1045.pdf