Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06039904 |
| Other study ID # |
COA.MURA2021/292 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 8, 2021 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Ramathibodi Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
INTRODUCTION Knee supports, usually made with sponge cushion, are used to protect knee joint
and prevent its injury. Sponge has less elasticity and durability compared with natural
rubber. To our knowledge, there has been no study regarding effectiveness of natural rubber
and sponge for knee joint protection and injury prevention in children with bleeding
disorders.
AIMS The study aimed to compare the effectiveness and satisfaction between natural rubber and
sponge knee supports for knee joint protection among children with bleeding disorders METHODS
The study had three phases: 1) measurement of compression force, 2) fabrication of knee
supports, and 3) a randomized crossover trial. The supports were fabricated in 4 sizes, S, M,
L, and XL. They comprised two parts: body, made from stretchable cotton; and cushion
(protection part), made from either natural rubber or sponge. The trial included 8 weeks of
alternatively wearing natural rubber knee support and sponge knee support with a 4-week
wash-out period. Numbers of knee bleeds and satisfied users were recorded.
Description:
The study employed a prospective design, conducted at the Faculty of Medicine Ramathibodi
Hospital, a tertiary care hospital in Thailand, from April 2021 to September 2022; and
approved by the Hospital's Committee on Human Rights Related to Research Involving Human
Subjects (COA. MURA2021/292). Written informed consents were obtained from individual
patients and their legal guardians. The study was divided into three phases: measurement of
transmitted impact force, fabrication of knee supports, and randomized cross-over trial of
natural rubber and sponge knee supports.
Phase I: Transmitted impact forces were measured using an impact tester (Model DC Power
Supply GW Instek GPS-30300 and Multi-Meter Fluke DT-9208a). Three types of knee support
samples, size 30 x 30 x 1 cm (W x L x H), were prepared: with no barrier, with natural rubber
cushion, and with sponge cushion and tested. The test was performed using the same force in
the ballistic pendulum test (1 kg momentum ball with a radius of 50 cm). The test was
repeated three times, and the average results were recorded as force (Newton) and time (sec)
after the sphere hit the receptive sensor. Natural rubber used in this study was made from
natural rubber and polymer (Patent ID 74814).
Phase II: Knee supports were designed and fabricated in various sizes. Three measurements,
knee circumferences, patella sizes, and knee heights, were taken from 20 Thai children aged
between 9 months and 10 years and having body weights within the 50th to 75th percentile. The
knee support comprised two parts, the support body and the protective cushion. The width of
the support body was derived from half of the knee circumference, and the length was taken
from 80% of the knee height, measured from knee to medial malleolus. From those measurements,
final knee supports were categorized into four sizes, S, M, L and XL according to widths and
lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28
cm. The support body was made of stretchable natural cotton fabrics, which were comfortable,
breathable, washable, less irritant and flexible.22 Similarly, the protective cushion was
classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters)
of 5, 6, 7 and 8 cm, respectively. Cushions were made from either natural rubber or sponge
and inserted at the front of the support body (to cover the patellar). As a result, natural
rubber and sponge knee supports were fabricated, and they both had similar external
appearance.
Phase III: A randomized cross-over trial using natural rubber and sponge knee supports was
conducted among patients with bleeding disorders. The patients were divided into two groups,
A and B, by computer-generated randomization sequence using a box of ten. A total of 44
patients were enrolled with 21 in Group A and the other 23 in Group B. Later, two patients in
Group A were excluded due to loss of follow-ups. Therefore, the final number of patients in
the study was 42 with 19 in Group A and 23 in Group B. Group A was first assigned to
Treatment I of natural rubber knee support followed by Treatment II of sponge knee support,
while Group B was first assigned to Treatment II followed by Treatment I. Patients were
advised to use the supports during physical activities; for example, walking and crawling
among toddlers and playing sports among school-aged children. Each treatment covered a period
of eight weeks, with four weeks of wash-out period of cross-over from the first treatment to
the second. Survey data on demographics, number of bleeds, types of bleeding (extraarticular
or intraarticular), and user's satisfaction were collected. User's compliance and bleeding
data, including severity and activity when injury occurred, were collected weekly using
freeware application, online electronic form, or direct telephone contact. Satisfaction
survey was conducted following the Client Satisfaction with Device module of Orthotics and
Prosthetic User' Survey (CSD-OPUS)24 with Thai translation. The survey consisted of nine
aspects: fitting well, weight, comfort, ease to use, attractiveness, durability, irritation,
pain, and overall satisfaction. Patients aged >7 years and all parents were included in the
survey, sent to them in electronic format, twice; i.e., at the end of the two treatments.
Scores were graded in absolutely agree, agree, disagree, and absolutely disagree. At the end
of the second treatment, parents of both groups were asked to choose either the knee support
of Treatment I or Treatment II as a preference.
Patients The inclusion criteria were bleeding disorder patients, aged 9 months to 12 years
old, with written consents The enrolled patients had no coexisting diseases affecting their
activities, or bleeding episodes two weeks before the study. Children or parents who were not
able to continue the study until the end were excluded.
