Trial Outcomes & Findings for Comparison of Braces for Treatment of Sever's Disease (NCT NCT03494647)
NCT ID: NCT03494647
Last Updated: 2022-05-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2022-05-25
Participant Flow
Participant milestones
| Measure |
Cheetah Heel Cup
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.
Cheetah Heel Cup: 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
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
The X Brace: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Braces for Treatment of Sever's Disease
Baseline characteristics by cohort
| Measure |
Cheetah Heel Cup
n=16 Participants
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.
Cheetah Heel Cup: 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
n=16 Participants
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
The X Brace: 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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 1.6 • n=93 Participants
|
10.1 years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
10.4 years
STANDARD_DEVIATION 1.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Height
|
138.2 cm
STANDARD_DEVIATION 10.7 • n=93 Participants
|
138.6 cm
STANDARD_DEVIATION 9.0 • n=4 Participants
|
138.4 cm
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Weight
|
32.7 kg
STANDARD_DEVIATION 7.6 • n=93 Participants
|
31.4 kg
STANDARD_DEVIATION 5.2 • n=4 Participants
|
32.05 kg
STANDARD_DEVIATION 6.4 • n=27 Participants
|
|
Diagnosed with Seber's disease
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Days from consent signed to beginning use of brace
|
6.8 Days
STANDARD_DEVIATION 4.2 • n=93 Participants
|
5.1 Days
STANDARD_DEVIATION 3.9 • n=4 Participants
|
5.95 Days
STANDARD_DEVIATION 4.05 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsThe 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.
Outcome measures
| Measure |
Cheetah Heel Cup
n=16 Participants
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.
Cheetah Heel Cup: 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
n=16 Participants
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
The X Brace: 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
Physical
|
0.27 score on a scale
Standard Deviation 0.22
|
0.22 score on a scale
Standard Deviation 0.18
|
|
Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores
School and play
|
0.19 score on a scale
Standard Deviation 0.19
|
0.18 score on a scale
Standard Deviation 0.25
|
|
Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores
Emotional wellbeing
|
0.13 score on a scale
Standard Deviation 0.08
|
0.05 score on a scale
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsThe 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.
Outcome measures
| Measure |
Cheetah Heel Cup
n=16 Participants
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.
Cheetah Heel Cup: 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
n=16 Participants
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
The X Brace: 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 Visual Analog Scale Pain Score
During sports
|
-42.4 score on a scale
Standard Deviation 30.5
|
-36.1 score on a scale
Standard Deviation 25.8
|
|
Changes in the Visual Analog Scale Pain Score
At rest
|
-9.5 score on a scale
Standard Deviation 23.1
|
-7.4 score on a scale
Standard Deviation 14.5
|
|
Changes in the Visual Analog Scale Pain Score
Daily living activities
|
-25.4 score on a scale
Standard Deviation 30.3
|
-23.6 score on a scale
Standard Deviation 23.2
|
Adverse Events
Cheetah Heel Cup
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
The X Brace
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cheetah Heel Cup
n=21 participants at risk
Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.
Cheetah Heel Cup: 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
n=22 participants at risk
Subjects randomly assigned to this group will receive the X Brace at their initial visit.
The X Brace: 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.
|
|---|---|---|
|
Product Issues
Heel pain with brace
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/22 • 3 months
|
|
Product Issues
No improvement in pain with brace
|
0.00%
0/21 • 3 months
|
4.5%
1/22 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place