Exercise Therapy and Physical Activity Modification for Patients With Sever's Disease
NCT07928232, Phase 2, Recruiting, California State University, Fullerton
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exercise Therapy and Physical Activity Modification for Patients With Sever's Disease | ClinicalTrials.gov |
| NCT number | NCT07928232 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | California State University, Fullerton | ClinicalTrials.gov |
| Conditions | Apophysitis; Calcaneus | ClinicalTrials.gov |
| Interventions | Exercise, Active Control | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Self-reported Achilles tendon or heel pain and Symptoms with Activity | Baseline, 6 weeks, and 12 weeks after randomization. | The Victorian Institute of Sport Assessment-Achilles (VISA-A) will be used. Survey completed via participant interview at baseline. Survey completed online by participants for follow-up visits. | ClinicalTrials.gov |
| Secondary | Single-leg Countermovement Jump Height | Baseline, 6 weeks, and 12 weeks after randomization. | Participants will be instructed to keep their arms behind their back and jump as high as possible on a flat surface. Jump height will be measured in cm via the MuscleLab contact grid. | ClinicalTrials.gov |
| Secondary | Single-leg Drop Countermovement Jump Height | Baseline, 6 weeks, and 12 weeks after randomization. | The drop CMJ is performed by standing on the edge of a 20cm box, then stepping off to land and immediately rebounding as high as possible. Jump height will be measured in cm via the MuscleLab contact grid. | ClinicalTrials.gov |
| Secondary | Total Heel-rise Work | Baseline, 6 weeks, and 12 weeks after randomization. | The heel-rise endurance test is performed barefoot while standing on a single leg on a slant board fixed at 10 degrees of dorsiflexion. Participants will be instructed to perform as many heel-rises as possible while maintaining a straight knee and a slight forward lean, lifting the heel as high as possible, to a metronome set at 60 beats/min (30 heel-rises/min). Participants will place only two fingers from each hand on the wall to maintain balance. The test will conclude when the participant is unable maintain the test cadence, elect to stop due to fatigue or pain, or perform consistent repetitions with compensation. A linear encoder will be taped to the posterior calcaneus, which records linear displacement (heel-rise height, cm) for each repetition. Total heel-rise work will be calculated in Joules by summing the displacement for each repetition, multiplied by body mass and the force of gravity. | ClinicalTrials.gov |
| Secondary | Achilles Tendon Cross-sectional Area | Baseline, 6 weeks, and 12 weeks after randomization. | B-mode ultrasound imaging (GE P9 Xdclear R4.5, GE Healthcare) will be used to assess the Achilles tendon cross-sectional area in short-axis images. CSA will be measured at the thickest portion of the free Achilles tendon. | ClinicalTrials.gov |
| Secondary | Shear Wave Velocity | Baseline, 6 weeks, and 12 weeks after randomization. | Shear wave velocity (SWV) will be measured using Ultrasound Shear Wave Elastography. SWV is a measurement of resistance to deformation (stiffness) in tendon. Participants will be positioned prone, with legs past the mid-shank suspended over the edge of the exam table and feet resting against a custom wall-mounted slant board to fix the ankles at 15 degrees of dorsiflexion. The region of interest will be between the anterior-posterior borders of the Achilles tendon visualized on b-mode ultrasound imaging in longitudinal axis and centered over the thickest portion of the free Achilles tendon. This distance will be documented from the cephalad border of the Achilles tendon osteotendinous junction (calcaneal notch). In cases of uniform thickness, the ROI will be standardized to 2cm proximal to the calcaneal notch. The average of three trials will be analyzed. | ClinicalTrials.gov |
| Secondary | Achilles Tendon Echogenicity | Baseline, 6 weeks, and 12 weeks after randomization. | The percentage of white to greyscale pixels (range 0-255) is calculated within a region of interest using the LAX Achilles tendon thickness images. | ClinicalTrials.gov |
| Secondary | Daily Step Count | 2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization. | Number of steps taken during waking hours measured using a wearable accelerometer- and inclinometer-based sensor (ActivPAL). Participants will wear the device continuously for 7 days at each study time point. | ClinicalTrials.gov |
| Secondary | Daily Activity Minutes | 2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization. | Daily minutes/day spent sitting, standing, stepping, and being sedentary will be averaged for each participant across all valid days using a wearable accelerometer- and inclinometer-based sensor (ActivPAL4+). Participants will wear the device continuously for 7 days at each study time point. Additionally, daily minutes at a moderate-to-vigorous activity stepping cadence will be analyzed. | ClinicalTrials.gov |
| Secondary | Foot and Ankle Outcome Score | Baseline, 6 weeks, and 12 weeks after randomization. | Assesses foot and ankle-related symptoms, function, participation, and quality of life | ClinicalTrials.gov |
| Secondary | Tampa Scale For Kinesiophobia | Baseline, 6 weeks, and 12 weeks after randomization. | ClinicalTrials.gov | |
| Secondary | Oxford Foot And Ankle Questionnaire Child Version | Baseline, 6 weeks, and 12 weeks after randomization. | ClinicalTrials.gov | |
| Secondary | Global Rating of Change | 6 weeks, and 12 weeks after randomization. | "Please rate the overall change in your condition from the time that you began the study until now." Measured on an 11-point likert scale, where -5 is "A very great deal worse", 0 is "No change", and +5 is "A very great deal better". | ClinicalTrials.gov |
| Secondary | Global Rating of Function | 6 weeks, and 12 weeks after randomization. | "On a scale of 0 - 100, please rate the use/function of your injured body part?" 0 is No Function/Unable to Use Injured Body Part, and 100 is ull Function/ Full use of Injured Body Part. | ClinicalTrials.gov |
| Secondary | Satisfaction | 6 weeks, and 12 weeks after randomization. | "How satisfied are you with the current use/function of your injured body part?" 0-10 scale, where 0 is "Not satisfied" and 10 is "Very satisfied". | ClinicalTrials.gov |
| Secondary | Patient Acceptable Symptom Scale | 6 weeks, and 12 weeks after randomization. | "Considering all the activities and sports you do each day, how much you hurt, and what you can do with and without pain, are you satisfied with your current condition?" Yes/No answer. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42316329 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)