An interventional study of Cheetah Heel Cup and The X Brace in Sever's Disease, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 8 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
This study is to learn more about braces that may help young athletes diagnosed with Sever's disease. Young athletes with this diagnosis who are seen by a Sports Medicine doctor will be asked it they want to be a part of the study. Patients who want to be in the study will be randomly assigned to wear one of two kinds of braces to treat their foot pain via randomization scheme independently created by a statistician. The subjects will be given the brace for free. The subjects will also answer survey questions about the brace when they first see the doctor, then at one, two, and three months after their first visit. Data collected in this study will help doctors gain a better understanding of how to treat young athletes who do sports without shoes who are diagnosed with Sever's disease.
It is widely accepted and scientifically confirmed that physical activity improves child health with positive effects on adiposity, musculoskeletal health and fitness, and cardiovascular health. Beyond the health benefits of physical activity alone, participation in sports at this crucial age enhances psychological and social health outcomes. Athletes with Sever's symptoms are limited in their ability to participate in physical activity and athletics, and it is suggested that active intervention in the management of Sever's is most appropriate to improve quality of life and outcomes without substantial time lost from sport or physical activity. Therefore, efficient and effective treatment is essential, especially for active and competitive athletes.
Standard treatment for Sever's disease is placement of heel cups in shoes and stretching or physical therapy. These interventions are effective in reducing Sever's patients' heel pain. A retrospective study showed that with treatment with a heel cup or other foot orthoses, symptoms improved within 2 months. However, there remains a distinct lack of randomized control trials evaluating treatments for Sever's in the literature. For the many young athletes with Sever's who participate in barefoot sports such as gymnastics, dance, or tae kwan do, the standard treatment is inadequate. They cannot use the recommended heel cups, which are placed in an athletic shoe. Currently, two braces are commonly used for barefoot athletes with Sever's: Cheetah Heel Cups and The X Brace. Neither of these braces are currently FDA approved as they are not considered medical devices and are marketed as an insert. Health care providers often recommend barefoot athletes purchase these braces, but no published studies evaluating their effectiveness exist in the established literature. This study will compare these two braces in an investigator-blinded, randomized control trial in order to contribute to the understanding of standard treatment for barefoot athletes with Sever's disease and improve patient outcomes by affecting clinical practice. In light of the paucity of information on and the importance of optimizing patient outcomes to improve quality of life and maintain an active lifestyle for young barefoot athletes, this prospective, randomized treatment study will compare the effectiveness of two braces in decreasing pain severity in barefoot athletes diagnosed with Sever's disease.
University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.
Device: Cheetah Heel Cup
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
Device: The X Brace
The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve.
The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot.
Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores
The OxAFQ-C is used to measure subjective well-being for child patients (aged 5-16) affected by foot and ankle conditions using issues that are considered important to children. There are three domains to the OxAFQ-C: physical, school and play, and emotional well-being. The investigators will calculate the difference in OxAFQ-C Scores which range from 0 to 100 with higher scores indicating better functioning and higher well-being.
Time frame: Baseline and 3 months
Changes in the Visual Analog Scale Pain Score
The Visual Analog Scale pain score is on a scale from 0 (no pain) to 100 (most severe pain). The investigators will calculate the difference in Visual Analog Scale Pain Scores.
Time frame: Baseline and 3 months
| Milestone | Cheetah Heel Cup | The X Brace |
|---|---|---|
| Started | 21 | 22 |
| Completed | 16 | 16 |
| Not completed | 5 | 6 |
The OxAFQ-C is used to measure subjective well-being for child patients (aged 5-16) affected by foot and ankle conditions using issues that are considered important to children. There are three domains to the OxAFQ-C: physical, school and play, and emotional well-being. The investigators will calculate the difference in OxAFQ-C Scores which range from 0 to 100 with higher scores indicating better functioning and higher well-being.
| score on a scale | Cheetah Heel Cup | The X Brace |
|---|---|---|
| Physical | 0.27 ± 0.22 | 0.22 ± 0.18 |
| School and play | 0.19 ± 0.19 | 0.18 ± 0.25 |
| Emotional wellbeing | 0.13 ± 0.08 | 0.05 ± 0.11 |
The Visual Analog Scale pain score is on a scale from 0 (no pain) to 100 (most severe pain). The investigators will calculate the difference in Visual Analog Scale Pain Scores.
| score on a scale | Cheetah Heel Cup | The X Brace |
|---|---|---|
| At rest | -9.5 ± 23.1 | -7.4 ± 14.5 |
| Daily living activities | -25.4 ± 30.3 | -23.6 ± 23.2 |
| During sports | -42.4 ± 30.5 | -36.1 ± 25.8 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cheetah Heel Cup | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| The X Brace | 0/22 (0%) | 0/22 (0%) | 1/22 (4.5%) |
| Event | Cheetah Heel Cup | The X Brace |
|---|---|---|
| Heel pain with braceProduct Issues | 1/21 | 0/22 |
| No improvement in pain with braceProduct Issues | 0/21 | 1/22 |
Baseline characteristics data was only collected for participants who completed the study.
| Age, Continuous(years) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| Mean | 10.6 ± 1.6 | 10.1 ± 1.6 | 10.4 ± 1.6 |
| Sex: Female, Male(Participants) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 15 | 15 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 11 | 11 | 22 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
| Height(cm) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| Mean | 138.2 ± 10.7 | 138.6 ± 9.0 | 138.4 ± 10 |
| Weight(kg) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| Mean | 32.7 ± 7.6 | 31.4 ± 5.2 | 32.05 ± 6.4 |
| Diagnosed with Seber's disease(Participants) | Cheetah Heel Cup | The X Brace | Total |
|---|---|---|---|
| Count of participants | 3 | 5 | 8 |
1 further baseline measures are reported on the registry.
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Plan to share: No — No sharing. Data is stored in RedCAP and will only be available for listed authors.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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