Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05598918 |
| Other study ID # |
09.2021.118 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Many active and passive rehabilitation programs are applied in the rehabilitation processes
after flexor tendon repair. There is no clear rehabilitation program accepted by the whole
world. An accurate understanding of these injuries at the histological and biomechanical
level is necessary to improve rehabilitation outcomes. Mechanical properties of tendons, such
as their viscoelasticity, are affected by the increase in stiffness caused by the rupture,
repair, and healing process. Previous studies have shown that the mechanical properties of a
repaired tendon, such as stiffness, material properties and functionality of tendon tissue
Shear-wave elastography can detect pathological changes in tendinopathy before they are
visible on conventional Ultrasonography imaging. In addition, shear wave elastography allows
the evaluation of quantitative measurements and is considered more objective because it
provides reproducible results. Our aim in this study is to evaluate the changes in the
mechanical properties of the hand flexor tendons repaired using shear wave elastography (SWE)
during the rehabilitation process and natural process and their effect on functionality.
Description:
Patients' affected tendons will be evaluated by shear wave elastography within 3 - 5 days
after surgery. The tendons of the healthy hands of the patients will also be evaluated as the
control group.
Afterwards, patients will be randomized into two groups by computer-assisted randomization.
Group 1: early passive mobilization Within 3 to 5 days following surgery, patients will begin
using a dorsal forearm-based orthosis with 30* flexion of the wrist, 70* flexion of the
metacarpophalangeal (MCP) joints, full extension of the interphalangeal (IF) joints. Home
exercises will be performed as passive flexion and active extension exercises with rubber
band 10 times per hour on the postoperative 3rd day for 3 weeks. Passive flexion and
extension exercises will be performed ten times a day, four times a day, on the MCP +
Proximal Interphalangeal (PIP) + IF joints. The bands will be removed at night and the
fingers will be kept in full extension. In 3 weeks, the orthosis will be modified so that the
wrist is in a neutral position and the MCP joints are extended a little more. Approximately 3
weeks after the repair, the dorsal orthosis will be removed during the exercises, and
non-resistance active movement and tenodesis exercises will be started in the presence of a
physiotherapist. From the 6th week, the dorsal orthosis will be worn only at night, tendon
gliding exercises and blocking exercises will be started.
Group 2: early active mobilization Patients will begin to use a dorsal forearm-based orthosis
that positions the wrist in a neutral position, metacarpophalangeal (MCP) joints 50* -70*
flexion, IF joints in full extension within 3 to 5 days after surgery. After the flexion
active extension exercises, full passive flexion of the fingers with the other intact hand
and then gently keeping the fingers in the flexion position for 3-5 seconds when the
contralateral hand is raised will be performed for 3 weeks, no force will be applied on the
fingers. Passive flexion and extension exercises will be performed ten times a day, four
times a day, on the MCP + PIP + IF joints. These exercises will be organized as a home
exercise program. The patients will be evaluated by the physiotherapist and clinician once a
week in the first two weeks of the exercises, and 3 days a week in the third week, in terms
of monitoring the exercises, and the exercises will be shown again. The bands will be removed
at night and the fingers will be kept in full extension. Approximately 3 weeks after the
repair, the dorsal orthosis will be removed during the exercises, and the patients will be
started with non-resistance active movement and tenodesis exercises in the form of a home
exercise program 3 days a week with a physiotherapist on the remaining days. From the 6th
week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking
exercises will be started.
Patients will be evaluated by an investigator blinded to the treatment groups at week 8 and
week 12 using the following methods.
1. Tendon elasticity will be evaluated with shear wave elastography
2. Measurements of hand grip strength and pinch strength (only at 12 weeks) will be
evaluated with a dynamometer device.
3. Duruoz Hand Index will be filled.
4. Total active movements of the fingers will be calculated.
