Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05563909 |
| Other study ID # |
07/09/2020-142688 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome. It occurs as a
result of compression of the median nerve as it passes through a restricted osteofibrous
canal in the wrist. Known as the carpal tunnel, this canal contains the wrist bones,
transverse carpal ligament, median nerve, and digital flexor tendons. Edema, tendon
inflammation, hormonal changes, and manual activity can contribute to increased nerve
compression and sometimes cause pain.
In this research, the investigators aim to present the virtual reality-mediated exercise
program to patients non-immersive. It is planned to use the Leap Motion motion sensor to
detect hand and wrist movements and to monitor the gamified setup on the computer screen.
In the system that will be presented via computer and hand motion sensor, the patient will be
asked to perform therapeutic exercises for the diagnosis of CTS in a scenario developed
through virtual reality. The investigators predict that patients will actively participate in
virtual reality-mediated therapeutic exercise program with high motivation and their
functional results will be better than classical exercise programs.
In our research, the investigators aim to present the tendon and nerve gliding exercises with
proven effectiveness in patients with CTS, with non-immersive virtual reality systems, and to
compare their effectiveness with the classical exercise program.
Description:
Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome. It occurs as a
result of compression of the median nerve as it passes through a restricted osteofibrous
canal in the wrist. Known as the carpal tunnel, this canal contains the wrist bones,
transverse carpal ligament, median nerve, and digital flexor tendons. Edema, tendon
inflammation, hormonal changes, and manual activity can contribute to increased nerve
compression and sometimes cause pain. In more severe cases, weakness may occur in the muscles
innervated by the median nerve, resulting in weakness in hand muscle strength(1). In a
comprehensive study, the mean age for the diagnosis of CTS was found to be 50 years, and its
prevalence was found to be similar in men and women. However, the prevalence was higher in
women; The incidence in women aged 65-74 was found to be four times higher than in men(2).
Many different treatment methods are used in the treatment of CTS, and these treatments
include regulation of daily activities, use of splints, tendon and nerve gliding exercises,
ESWT, manual therapy, kinesiotaping, physical therapy agents, medical symptomatic treatments,
injections into the carpal tunnel and surgical treatment options. .
Suspected risk factors for CTS include diabetes mellitus, menopause, hypothyroidism, obesity,
arthritis, and pregnancy. Since hypothyroidism, menopause, and pregnancy are risk factors,
there is a strong suspicion that hormonal changes may play a role in the etiology of CTS;
however, no evidence was found to support this hypothesis.
In the diagnosis of CTS, a comprehensive and accurate clinical history should be taken
together with the exclusion of other possible causes. The syndrome is characterized by
intermittent and then increasing nocturnal paresthesia and dysesthesia findings. Later,
sensory loss develops with hand muscle weakness and muscle atrophy of the thenar region,
resulting from extensive axonal degeneration in the course of the disease. This set of
symptoms is quite typical and rarely occurs in disorders other than CTS. In severe CTS cases,
paresthesia symptoms may spread to the proximal forearm and upper arm, and sometimes to the
shoulder(3).
In the following periods, loss of strength and atrophy of the thenar region muscles may
occur. The diagnosis is made by clinical examination, electrophysiological methods (EMG) and
imaging methods (such as ultrasound, magnetic resonance imaging). The clinical examination
consists of sensory-motor examination and provocative tests. 1-2-3 on sensory examination.
numbness with touch (paresthesia) or low sense of touch (hypoesthesia) in the fingers are
detected. Motor examination may be normal in the early stage, and later on, weakness
(weakness) in the thumb abducting and opposing muscle is detected.
In the first of the provocative tests, when the inside of the patient's wrist is hit with a
reflex hammer, the patient usually feels an electric shock sensation in the first 3 fingers
of the hand or a tingling sensation spreading to these fingers. This is known as Tinel's
sign. In another clinical test, the patient is asked to flex both wrists (both wrists are
flexed and the backs of both hands are touching each other) for 1 minute. In case of numbness
and tingling spreading to the fingers, the test is considered positive (significant). , this
is called the 'Phalen test'. Another diagnostic method, EMG, is performed by recording and
evaluating electrical signals coming from nerves and muscles, using electricity and needles
to diagnose nerve and muscle diseases. In CTS, a decrease in the conduction velocity of the
median nerve is detected. In the diagnosis of CTS, the diagnosis is mostly made when the
clinical picture and electrophysiological findings are evaluated well, but magnetic resonance
imaging may be useful in some special cases (formations such as space-occupying tumors).
CTS treatment is divided into conservative and surgical. Conservative treatment methods
include splinting (an assistive device worn on the body to relieve the nerve), exercise
(sliding movements of the median nerve in the wrist and wrist flexor tendons), local
corticosteroid injection (corticosteroid injection into the carpal tunnel), and ultrasound
(deep with sound energy) from physical therapy applications. tissue heating), TENS (pain
relief by applying controlled low-voltage electric current to the nervous system through the
skin with electrodes placed on the skin), paraffin bath (immersion of the hand in a heated
paraffin pool), ergonomic arrangements. Surgical treatment includes decompression of the
nerve (4).
Virtual reality; It is defined as the use of interactive simulations created with computer
hardware and software to offer users opportunities to enter environments that look and feel
like real-world objects and events. With the feeling of being in that environment and the
possibility of interacting with the environment, it differs from products such as video and
television(5).
Virtual reality applications are grouped under 2 main headings as "immersive" and
"non-immersive" according to the level of user coverage of the environment. The degree of
inclusiveness of the offered virtual environment depends on the level of interaction, as well
as the ability to isolate the user from stimuli outside the virtual environment (such as
external sounds and lights). In immersive virtual reality systems, head-mounted screens (in
the form of head-mounted display; headgear, mask or glasses) are used, while non-immersive
virtual reality systems use screens(6). In this research the investigators aim to present the
virtual reality-mediated exercise program to patients non-immersive. It is planned to use the
Leap Motion motion sensor to detect hand and wrist movements and to monitor the gamified
setup on the computer screen. The Leap Motion sensor is a hand motion sensor that rests on a
stable platform and has no wearable or mountable parts on the patient. The Leap Motion
sensor, whose main use is to control computers hands-free, has no potential harm to patients.
Within the scope of this research, no part will be placed on the hand or wrist of the
patients, they will only be asked to move their hands at a distance of 30 cm from the
relevant sensor.
In the system that will be presented via computer and hand motion sensor, the patient will be
asked to perform therapeutic exercises for the diagnosis of CTS in a scenario developed
through virtual reality. The investigators predict that patients will actively participate in
virtual reality-mediated therapeutic exercise program with high motivation and their
functional results will be better than classical exercise programs.
The use of different rehabilitation protocols, which are also referred to as "serious games"
in the medical field, in gamification and treatment has recently attracted attention. Virtual
reality-mediated exercises are used for neurological rehabilitation to reduce disability
caused by different neurological diseases such as cerebral palsy, stroke, Parkinson's
Disease, multiple sclerosis, neurodegenerative diseases(7). In addition to neurological
diseases, virtual reality-based rehabilitation methods; It has also been used in studies for
scoliosis exercises, cardiac rehabilitation, chronic pain management, and pulmonary
rehabilitation and its effectiveness has been demonstrated (8,9,10).
In our research, the investigators aim to present the tendon and nerve gliding exercises with
proven effectiveness in patients with CTS, with non-immersive virtual reality systems, and to
compare their effectiveness with the classical exercise program.
