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Protection of Knee Joints in Bleeding Disorder Patients

NCT06039904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-09-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Natural rubber knee support

The knee support comprised two parts, the support body and the protective cushion. Which 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. 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 and inserted at the front of the support body (to cover the patellar).

DEVICE

Sponge knee support

The knee support comprised two parts, the support body and the protective cushion. Which 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. 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 sponge and inserted at the front of the support body (to cover the patellar).

Sponsors & Collaborators

  • Ramathibodi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
9 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2022-04-01
Completion
2022-09-01

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039904 on ClinicalTrials.gov