Trials / Completed
CompletedNCT04816188
Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- University of Delaware · Academic / Other
- Sex
- All
- Age
- 7 Years – 17 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Exercise Therapy and Activity Modification | Daily lower leg strengthening exercises Therapy and pain-guided activity modification. |
Timeline
- Start date
- 2021-03-15
- Primary completion
- 2023-07-25
- Completion
- 2023-07-25
- First posted
- 2021-03-25
- Last updated
- 2024-06-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04816188. Inclusion in this directory is not an endorsement.