Sever's DiseaseNCT04816188
Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
A study testing Exercise Therapy and Activity Modification in people with Sever's Disease and Achilles Tendinopathy, run by University of Delaware at 1 site in United States.
Trial summary
Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Sever's Disease, Achilles Tendinopathy, Insertional Achilles Tendinopathy
- What is being tested?
- Exercise Therapy and Activity Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Insidious onset of heel pain with running or jumping activities lasting at least three weeks
- Location of pain is focal at the calcaneus over the Achilles tendon attachment and/or the Achilles tendon
Who cannot join
- Subjects having an underlying diagnosis predisposing to heel pain (spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
- History of calcaneal fracture or foot/ankle surgery in the past 6 months
- Another injury that limits the ability to perform exercises on the injured leg
Trial locations and contacts
1 site in 1 country.
About this study
Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.
Read the detailed description
Investigators will recruit 30 subjects between ages 7-17 with heel pain and also invite their parent/guardian to participate in this research study. Participants will be evaluated at baseline, 4-weeks, 8-weeks and 12-weeks. Data collections at each assessment visit will be identical except for the baseline visit. The baseline evaluation will consist of questionnaires related to past medical history in addition to all other procedures. All evaluations will include patient-reported outcome measures, clinical measures, and measurement of tendon structure, mechanical properties, and muscle-tendon function Treatment sessions will occur immediately following the evaluation sessions (4 total). During treatment sessions, participants will be provided with education, therapeutic exercise instruction, and discussion of their training diary and home exercise program. Treatment sessions will last 30-45 minutes. In addition to the 4 in-person treatment sessions, virtual visits will take place 2 weeks in between each in-person visits, (one virtual visit maximum every 4 weeks) as needed. Virtual visits will be no longer than 30 minutes to discuss patient needs.
- Conditions
- Sever's Disease, Achilles Tendinopathy, Insertional Achilles Tendinopathy, Apophysitis; Calcaneus
- Being tested
- Exercise Therapy and Activity Modification
- Keywords
- Achilles tendon, Pain, Activity modification, Sever's disease, Achilles tendinopathy, Apophysitis, Exercise
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Therapy and Activity ModificationOther
Daily lower leg strengthening exercises Therapy and pain-guided activity modification.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Activity Modification | Experimental | Not described Receives: Other: Exercise Therapy and Activity Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
The VISA-A was specifically designed to assess symptom severity in individuals with Achilles tendinopathy and has demonstrated validity, reliability and responsiveness. Scores range from 0-100, where a higher score indicates less pain and symptoms with activity. This outcome measure has been used in previous trials with adolescents.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale
The PROMIS Pain Interference Scale assesses symptom severity and pain with daily activity. Raw scores range from 8-40, where lower scores indicate less pain interference.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Tendon Structure
Ultrasound images will be obtained using the LOGIQ e Ultrasound (GE Healthcare) system using a wide-band linear array probe (5.0-13.0 MHz). The subject will be prone lying with the hips and knees straight and the ankles hanging outside the treatment table. Three longitudinal images where the calcaneal insertion and as much of the tendon is visible will be saved. Three extended field of view images of the tendon between the insertion to the calcaneus and the start of the soleus muscle will be saved. Longitudinal and cross-sectional images will be taken at the area of tenderness to palpation on the injured side and at the same position on the contralateral side. These images will be used to evaluate tendon thickening, cross-sectional area, and the occurrence of hypoechoic areas.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Tendon Mechanical Properties
Subjects will be examined using continuous shear wave elastography (cSWE). This is a non-invasive technique that uses a low-amplitude vibration to mechanically perturbate the tendon. The resultant shear wave is imaged using ultrasound. The area of maximum tendon pathology will be identified using palpation and B mode ultrasound imaging. The distance from calcaneal insertion to this area will be measured to allow for identification of a comparable location on the asymptomatic side as well as to ensure the same area is assessed at each follow-up. The ultrasound probe for cSWE will be placed at this location and the actuator will be placed just proximal to the ultrasound probe.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Muscle-Tendon Function
Muscle-tendon function will be assessed by a functional test battery including a single-leg counter movement jump (CMJ), a single-leg drop CMJ, single-leg hopping, and the heel-rise endurance test. For jump tests, the jump height for three trials will be recorded using a light mat (MuscleLab®, Ergotest Innovations, Porsgrunn, Norway). The drop CMJ jump is performed on single leg by jumping from a 20cm high box, landing, and immediately jumping up for maximum height. Hopping is similar or jumping rope on one foot; two trials of 20 hops will be recorded using a light mat to calculate hop frequency, average height, and plyometric quotient (flight time / contact time). The heel-rise endurance test is a single-leg standing heel-rise test. The heel-rise test for endurance is performed on one leg at a time with the participant standing on a box with an incline of 10°. A metronome is used to maintain the frequency of 30 heel-rises per minute.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Compliance
Compliance will be tracked using training diaries. The number of training diaries and prescribed exercise sessions completed, and days in adherence with activity modification guidelines will be recorded. Compliance rates will be reported as a percentage, relative to the participants duration of participation in the study.
Measured: Average compliance rate for each group over first year of study recruitment
Secondary outcomes (11)
PROMIS Pediatric Global Health questionnaire
The PROMIS Pediatric Global Health questionnaire will be used to assess self-reported impact of injury on mental and physical health. Raw scores range from 7-35, where higher scores indicate higher physical and mental health.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Pediatric Physical Activity Short Form questionnaire
The PROMIS Pediatric Physical Activity Short Form questionnaire will be used to assess self-reported capability over a 7 day period. Raw scores range from 8-40, where a higher score indicates higher physical activity levels.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
The Foot and Ankle Outcomes Score (FAOS)
Three subscales from The Foot and Ankle Outcomes Score (FAOS) will be used to measure foot and ankle-related quality of life (FOAS-QoL), symptoms (FAOS-S), and function in sport and recreation. Each subscale ranges from 0-100, where higher scores indicate better outcomes.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
The Fear of Pain Questionnaire Child Report (FOBQC)
The Fear of Pain Questionnaire Child Report (FOBQC) will assess fear of pain and avoidance of activities. Scores range from 0-96, where 0-34 indicates low fear and 51-96 indicates high fear.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
The Global Rating of Change (GROC) scale
The Global Rating of Change (GROC) scale, will be used to measure their satisfaction and perceived recovery of their child using a 10-point likert respectively ranging from -5 to +5 indicating a range between "not satisfied" to "very satisfied" and "much worse" to "much improved".
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Pain Intensity questionnaire
PROMIS Parent Proxy Pain Intensity will assess symptom severity from the parent's perspective. Parents are asked to rate their child's pain at it's worst on a scale of 0-10, where 0 is "no pain" and 10 is "worst pain imaginable".
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Pain Interference questionnaire
The PROMIS Parent Proxy Pain Interference Scale assesses symptom severity and pain with daily activity from the parent's perspective. Raw scores range from 8-40, where lower scores indicate less pain interference.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Global Health questionnaire
The PROMIS Parent Proxy Global Health questionnaire will assess the parent's perspective on the participant's mental and physical health. Raw scores range from 7-35, where higher scores indicate higher physical and mental health.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Physical Activity questionnaire
The PROMIS Parent Proxy Physical Activity form will be used to assess parent-reported capability of their child's physical activities over a 7 day period. Raw scores range from 4-20, where a higher score indicates higher physical activity level.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Fear of Pain Questionnaire Parent Report (FOBQP)
The Fear of Pain Questionnaire Parent Report (FOBQP) is a parent inventory to assess child pain-related fears. Scores range from 0-96, where 0-34 indicates low fear and 51-96 indicates high fear.
Measured: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Ankle range of motion
Ankle range of motion in non-weight bearing and weight bearing positions will be measured with a goniometer.
Measured: Change over time with evaluations at baseline, 4-weeks, 8-weeks,10-weeks, and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start15 Mar 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sever's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Silbernagel, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816188
- Sponsor's protocol ID
- 1652996
- Status last verified
- Jun 2024
- First submitted
- 18 Mar 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rachel JN, Williams JB, Sawyer JR, Warner WC, Kelly DM. Is radiographic evaluation necessary in children with a clinical diagnosis of calcaneal apophysitis (sever disease)? J Pediatr Orthop. 2011 Jul-Aug;31(5):548-50. doi: 10.1097/BPO.0b013e318219905c.
PubMed 21654464Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335.
PubMed 11579069Suryavanshi JR, Goto R, Jivanelli B; PRiSM Outcomes Measures Research Interest Group; Aberdeen J, Duer T, Lam KC, Franklin CC, MacDonald J, Shea KG, Fabricant PD. Age-Appropriate Pediatric Sports Patient-Reported Outcome Measures and Their Psychometric Properties: A Systematic Review. Am J Sports Med. 2019 Nov;47(13):3270-3276. doi: 10.1177/0363546518818822. Epub 2019 Jan 16.
PubMed 30649907Rathleff MS, Graven-Nielsen T, Holmich P, Winiarski L, Krommes K, Holden S, Thorborg K. Activity Modification and Load Management of Adolescents With Patellofemoral Pain: A Prospective Intervention Study Including 151 Adolescents. Am J Sports Med. 2019 Jun;47(7):1629-1637. doi: 10.1177/0363546519843915. Epub 2019 May 16.
PubMed 31095417Forrest CB, Bevans KB, Pratiwadi R, Moon J, Teneralli RE, Minton JM, Tucker CA. Development of the PROMIS (R) pediatric global health (PGH-7) measure. Qual Life Res. 2014 May;23(4):1221-31. doi: 10.1007/s11136-013-0581-8. Epub 2013 Nov 22.
PubMed 24264804Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004.
PubMed 11642530Simons LE, Sieberg CB, Carpino E, Logan D, Berde C. The Fear of Pain Questionnaire (FOPQ): assessment of pain-related fear among children and adolescents with chronic pain. J Pain. 2011 Jun;12(6):677-86. doi: 10.1016/j.jpain.2010.12.008. Epub 2011 Feb 26.
PubMed 21354866Silbernagel KG, Shelley K, Powell S, Varrecchia S. Extended field of view ultrasound imaging to evaluate Achilles tendon length and thickness: a reliability and validity study. Muscles Ligaments Tendons J. 2016 May 19;6(1):104-10. doi: 10.11138/mltj/2016.6.1.104. eCollection 2016 Jan-Mar.
PubMed 27331037Zellers JA, Bley BC, Pohlig RT, Alghamdi NH, Silbernagel KG. FREQUENCY OF PATHOLOGY ON DIAGNOSTIC ULTRASOUND AND RELATIONSHIP TO PATIENT DEMOGRAPHICS IN INDIVIDUALS WITH INSERTIONAL ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):761-769.
PubMed 31598414Cortes DH, Suydam SM, Silbernagel KG, Buchanan TS, Elliott DM. Continuous Shear Wave Elastography: A New Method to Measure Viscoelastic Properties of Tendons in Vivo. Ultrasound Med Biol. 2015 Jun;41(6):1518-29. doi: 10.1016/j.ultrasmedbio.2015.02.001. Epub 2015 Mar 19.
PubMed 25796414Silbernagel KG, Gustavsson A, Thomee R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1207-17. doi: 10.1007/s00167-006-0150-6. Epub 2006 Jul 21.
PubMed 16858560Silbernagel KG, Thomee R, Eriksson BI, Karlsson J. Continued sports activity, using a pain-monitoring model, during rehabilitation in patients with Achilles tendinopathy: a randomized controlled study. Am J Sports Med. 2007 Jun;35(6):897-906. doi: 10.1177/0363546506298279. Epub 2007 Feb 16.
PubMed 17307888Hanlon SL, Seymore KD, Potter MN, Bley BC, Silbernagel KG. The feasibility of a novel exercise therapy and activity modification intervention for patients with Sever's disease. Pilot Feasibility Stud. 2026 Jun 18. doi: 10.1186/s40814-026-01850-6. Online ahead of print.
PubMed 42316329
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
- ClinicalTrials.gov ID
- NCT04816188
- Acronym / sponsor ID
- 1652996
- Conditions
- Sever's Disease, Achilles Tendinopathy, Insertional Achilles Tendinopathy, Apophysitis; Calcaneus
- Keywords
- Achilles tendon, Pain, Activity modification, Sever's disease, Achilles tendinopathy, Apophysitis, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.
Detailed description
Investigators will recruit 30 subjects between ages 7-17 with heel pain and also invite their parent/guardian to participate in this research study. Participants will be evaluated at baseline, 4-weeks, 8-weeks and 12-weeks. Data collections at each assessment visit will be identical except for the baseline visit. The baseline evaluation will consist of questionnaires related to past medical history in addition to all other procedures. All evaluations will include patient-reported outcome measures, clinical measures, and measurement of tendon structure, mechanical properties, and muscle-tendon function Treatment sessions will occur immediately following the evaluation sessions (4 total). During treatment sessions, participants will be provided with education, therapeutic exercise instruction, and discussion of their training diary and home exercise program. Treatment sessions will last 30-45 minutes. In addition to the 4 in-person treatment sessions, virtual visits will take place 2 weeks in between each in-person visits, (one virtual visit maximum every 4 weeks) as needed. Virtual visits will be no longer than 30 minutes to discuss patient needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise and Activity Modification | Experimental | Other: Exercise Therapy and Activity Modification |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Insidious onset of heel pain with running or jumping activities lasting at least three weeks
- Location of pain is focal at the calcaneus over the Achilles tendon attachment and/or the Achilles tendon
Key exclusion criteria (3 listed)
- Subjects having an underlying diagnosis predisposing to heel pain (spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
- History of calcaneal fracture or foot/ankle surgery in the past 6 months
- Another injury that limits the ability to perform exercises on the injured leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Therapy and Activity ModificationDaily lower leg strengthening exercises Therapy and pain-guided activity modification. | Other | Exercise and Activity Modification |
Primary outcome
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
The VISA-A was specifically designed to assess symptom severity in individuals with Achilles tendinopathy and has demonstrated validity, reliability and responsiveness. Scores range from 0-100, where a higher score indicates less pain and symptoms with activity. This outcome measure has been used in previous trials with adolescents.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
The PROMIS Pain Interference Scale assesses symptom severity and pain with daily activity. Raw scores range from 8-40, where lower scores indicate less pain interference.
Tendon Structure
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Ultrasound images will be obtained using the LOGIQ e Ultrasound (GE Healthcare) system using a wide-band linear array probe (5.0-13.0 MHz). The subject will be prone lying with the hips and knees straight and the ankles hanging outside the treatment table. Three longitudinal images where the calcaneal insertion and as much of the tendon is visible will be saved. Three extended field of view images of the tendon between the insertion to the calcaneus and the start of the soleus muscle will be saved. Longitudinal and cross-sectional images will be taken at the area of tenderness to palpation on the injured side and at the same position on the contralateral side. These images will be used to evaluate tendon thickening, cross-sectional area, and the occurrence of hypoechoic areas.
Tendon Mechanical Properties
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Subjects will be examined using continuous shear wave elastography (cSWE). This is a non-invasive technique that uses a low-amplitude vibration to mechanically perturbate the tendon. The resultant shear wave is imaged using ultrasound. The area of maximum tendon pathology will be identified using palpation and B mode ultrasound imaging. The distance from calcaneal insertion to this area will be measured to allow for identification of a comparable location on the asymptomatic side as well as to ensure the same area is assessed at each follow-up. The ultrasound probe for cSWE will be placed at this location and the actuator will be placed just proximal to the ultrasound probe.
Muscle-Tendon Function
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Muscle-tendon function will be assessed by a functional test battery including a single-leg counter movement jump (CMJ), a single-leg drop CMJ, single-leg hopping, and the heel-rise endurance test. For jump tests, the jump height for three trials will be recorded using a light mat (MuscleLab®, Ergotest Innovations, Porsgrunn, Norway). The drop CMJ jump is performed on single leg by jumping from a 20cm high box, landing, and immediately jumping up for maximum height. Hopping is similar or jumping rope on one foot; two trials of 20 hops will be recorded using a light mat to calculate hop frequency, average height, and plyometric quotient (flight time / contact time). The heel-rise endurance test is a single-leg standing heel-rise test. The heel-rise test for endurance is performed on one leg at a time with the participant standing on a box with an incline of 10°. A metronome is used to maintain the frequency of 30 heel-rises per minute.
Compliance
Time frame: Average compliance rate for each group over first year of study recruitment
Compliance will be tracked using training diaries. The number of training diaries and prescribed exercise sessions completed, and days in adherence with activity modification guidelines will be recorded. Compliance rates will be reported as a percentage, relative to the participants duration of participation in the study.
11 secondary outcomes
PROMIS Pediatric Global Health questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Pediatric Physical Activity Short Form questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
The Foot and Ankle Outcomes Score (FAOS)
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
The Fear of Pain Questionnaire Child Report (FOBQC)
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
The Global Rating of Change (GROC) scale
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Pain Intensity questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Pain Interference questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Global Health questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
PROMIS Parent Proxy Physical Activity questionnaire
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Fear of Pain Questionnaire Parent Report (FOBQP)
Time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Ankle range of motion
Time frame: Change over time with evaluations at baseline, 4-weeks, 8-weeks,10-weeks, and 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 21654464Rachel JN, Williams JB, Sawyer JR, Warner WC, Kelly DM. Is radiographic evaluation necessary in children with a clinical diagnosis of calcaneal apophysitis (sever disease)? J Pediatr Orthop. 2011 Jul-Aug;31(5):548-50. doi: 10.1097/BPO.0b013e318219905c.
- Background: PubMed 11579069Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335.
- Background: PubMed 30649907Suryavanshi JR, Goto R, Jivanelli B; PRiSM Outcomes Measures Research Interest Group; Aberdeen J, Duer T, Lam KC, Franklin CC, MacDonald J, Shea KG, Fabricant PD. Age-Appropriate Pediatric Sports Patient-Reported Outcome Measures and Their Psychometric Properties: A Systematic Review. Am J Sports Med. 2019 Nov;47(13):3270-3276. doi: 10.1177/0363546518818822. Epub 2019 Jan 16.
- Background: PubMed 31095417Rathleff MS, Graven-Nielsen T, Holmich P, Winiarski L, Krommes K, Holden S, Thorborg K. Activity Modification and Load Management of Adolescents With Patellofemoral Pain: A Prospective Intervention Study Including 151 Adolescents. Am J Sports Med. 2019 Jun;47(7):1629-1637. doi: 10.1177/0363546519843915. Epub 2019 May 16.
- Background: PubMed 24264804Forrest CB, Bevans KB, Pratiwadi R, Moon J, Teneralli RE, Minton JM, Tucker CA. Development of the PROMIS (R) pediatric global health (PGH-7) measure. Qual Life Res. 2014 May;23(4):1221-31. doi: 10.1007/s11136-013-0581-8. Epub 2013 Nov 22.
- Background: PubMed 11642530Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004.
- Background: PubMed 21354866Simons LE, Sieberg CB, Carpino E, Logan D, Berde C. The Fear of Pain Questionnaire (FOPQ): assessment of pain-related fear among children and adolescents with chronic pain. J Pain. 2011 Jun;12(6):677-86. doi: 10.1016/j.jpain.2010.12.008. Epub 2011 Feb 26.
- Background: PubMed 27331037Silbernagel KG, Shelley K, Powell S, Varrecchia S. Extended field of view ultrasound imaging to evaluate Achilles tendon length and thickness: a reliability and validity study. Muscles Ligaments Tendons J. 2016 May 19;6(1):104-10. doi: 10.11138/mltj/2016.6.1.104. eCollection 2016 Jan-Mar.
- Background: PubMed 31598414Zellers JA, Bley BC, Pohlig RT, Alghamdi NH, Silbernagel KG. FREQUENCY OF PATHOLOGY ON DIAGNOSTIC ULTRASOUND AND RELATIONSHIP TO PATIENT DEMOGRAPHICS IN INDIVIDUALS WITH INSERTIONAL ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):761-769.
- Background: PubMed 25796414Cortes DH, Suydam SM, Silbernagel KG, Buchanan TS, Elliott DM. Continuous Shear Wave Elastography: A New Method to Measure Viscoelastic Properties of Tendons in Vivo. Ultrasound Med Biol. 2015 Jun;41(6):1518-29. doi: 10.1016/j.ultrasmedbio.2015.02.001. Epub 2015 Mar 19.
- Background: PubMed 16858560Silbernagel KG, Gustavsson A, Thomee R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1207-17. doi: 10.1007/s00167-006-0150-6. Epub 2006 Jul 21.
- Background: PubMed 17307888Silbernagel KG, Thomee R, Eriksson BI, Karlsson J. Continued sports activity, using a pain-monitoring model, during rehabilitation in patients with Achilles tendinopathy: a randomized controlled study. Am J Sports Med. 2007 Jun;35(6):897-906. doi: 10.1177/0363546506298279. Epub 2007 Feb 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy and Activity Modification in people with Sever's Disease and Achilles Tendinopathy, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire (time frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816188, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.