Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05360316 |
| Other study ID # |
Firat Uni |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2020 |
| Est. completion date |
May 4, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Firat University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sensory and balance losses occur in hemiplegic patients. In some patients, sensory and
balance rehabilitations may vary depending on the treatment they receive, depending on the
treatment. It is a fact that the affected anatomic neuronal regions can cause different
damages for each person together with interneuronal relations. This study aims to sense
sensation with Extracorporeal Shock Wave Therapy to be applied to the plantar region.
Description:
Every year in England and Wales, 110,000 people experience first stroke and 30,000 people
experience other stroke events following the first stroke. Stroke is one of the most
important events causing severe distress and is shown as the third most common cause of death
in England. Most of the health and social care resources budget uses it to meet the acute and
chronic care of stroke patients. 5% of all hospital expenses are spent for the care of stroke
patients. Stroke causes 88% of the death causes of the 65 and over life group and 10-12% of
all deaths in industrial countries. Stroke can always be an obstacle in patients and cause
them to need long-term care. After the stroke, patients apply to the hospital due to
psychological, social and physical problems. The sudden loss of functionality creates strong
stress not only in the patient but also in the family. Neurological damage can also become
irreversible distress. Signs and symptoms related to stroke vary depending on the
localization and severity of the damage. Stroke often results in paralysis of one side of the
body. Paralysis of one side of the body occurs on the opposite side of the damaged side of
the brain. Stopping blood flow to the brain causes focal function loss up to various levels
in the patient. The most common motor is loss. Other neurological losses are visual, sensory,
communicative, swallowing and perceptual problems.
Kinesthesis and vibration losses are especially evident in the distal parts of the
extremities. Kinesthesis and loss of position sense cause irregular and excessively flawed
movements that are performed voluntarily with insufficient information about proprioception
to the sensory cortex. Such patients are able to stand or walk, although they are not very
balanced, as they can somewhat assess the position of their body parts with the sense of
vision; but they have great difficulty walking in the dark.
Shock waves have been used extensively to study their effects on sensory nerves and nerve
endings. Application of 1000 impulses of shock waves (0.08 mJ/mm, 2.4 Hz) resulted in the
degeneration of sensory nerve fibers and endings followed by reinnervation of the affected
skin areas These changes were accompanied by the reversible and rapid loss of the
immunohistochemical markers protein gene product 9.5 and calcitonin gene-related peptide.
However, a second application of the same dose of shock waves had a cumulative effect on the
treated nerves, leading to delayed reinnervation. It appears, therefore, that shock
wave-treated nerves develop a "memory effect" after the first treatment, and Extracorporeal
Shock Wave Therapy (ESWT) repeated shortly after the first treatment is not beneficial. It is
expected that ESWT induces subtle changes in the affected neurons whose axons have been
treated. Investigators detected an increased expression of activating transcription factor 3
(ATF-3) and growth-associated phosphoprotein 43 (GAP-43) in dorsal root ganglion neurons of
shock wave-treated rats, indicating that the molecular changes after ESWT are not restricted
to the treated axons: their cell bodies are also activated in a retrograde manner. The
question remains open as to whether doses of ESWT in the therapeutic range would induce
similar changes as the 2000 impulses applied in this study. ATF-3 and GAP-43 are markers
thought to be associated with the activation of neurons and glial cells (Schwann cells) after
peripheral nerve injuries.
As regards the dose-effect relationship of ESWT on peripheral nerves, a large body of
evidence suggests that shock wave doses greater than 900 impulses combined with a flux
density of 0.08 mJ/mm2 induce damage to the affected nerves, manifested in impaired
electrophysiological conduction parameters, a disrupted neurofilament staining pattern of the
treated axons, and degeneration of the myelin sheaths at the levels of light and electron
microscopy. These doses appeared to damage motor and sensory nerves equally. This
experimental and clinical experience indicates that the therapeutically applicable dose for
the promotion of nerve regeneration without side effects is likely to be lower than 500
impulses. The effect of such doses is highly dependent on the depth of the target tissue and
the treated surface area.
In this study, the effect of ESWT on sensory nerves will be used in individuals with
hemiplegia. Thus, mobility and plantar region sensory development of plantar sensory
stimulation will be evaluated in individuals with hemiplegia. A study specific to the
literature will be presented by evaluating the effect of evaluation results on the function.
