Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05465603 |
Other study ID # |
001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2022 |
Est. completion date |
December 14, 2022 |
Study information
Verified date |
January 2023 |
Source |
Hand Therapy Barcelona |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Introduction: Flexion contracture is one of the most frequent complications in finger trauma.
The use of orthoses to obtain the best total end range time (TERT) is the most popular method
to treat this pathology . Until now, no orthosis applied for longer than 3 weeks had been
able to achieve TERT longer than 12 hours.
Purpose of the study: To assess whether the elastic tension digital neoprene orthosis
(ETDNO), using a serial dynamic program, can achieve a better result in ROM and TERT than
other orthoses described in the literature.
Methods: analysis of outcomes in a sample of 30 patients with PIP joint flexion contracture
treated with the ETDNO and serial dynamic program.
Description:
In this study the researcher will compare the efect of daily TERT treatment on the proximal
interphalangeal joint contracture using an ETDNO. The investigator will treat two different
groups one with a dose of from 11 to 13 hours of the ETDNO while the other one is treated
with a dose of from 20 to 22 hours of daily TERT with the same device. This treatment will
last three weeks and will be evalauted the first day, the he first week and the third week.
At the end of the study the researcher will quantify the improvement on both groups to know
which dailyTERT dose is the best option.