Clinical trial NCT05837715: Effects of Cervical Stabilization Exercises and Vibration Application in Individuals With Parkinson's Disease
Official title: Investigation of the Effects of Cervical Stabilization Exercises and Vibration Application to the Cervical Region on Motor Symptoms and Sensory Profile in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: cervical
stabilization exercises
vibration
motor symptoms
impaired sensation
Parkinson disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is the second most common neurodegenerative disease that causes a progressive decrease in motor functions, which is caused by the influence of dopaminergic pathways in the substantia nigra (SN). Motor and non-motor symptoms seen in PD seriously affect patients negatively.

Proprioception, which is one of the deep senses, is known to help maintain body verticalization in the sense of posture and movement and has a primary importance in the regulation of motor activities. Depending on the progression of the disease, flexion of the body is triggered as a result of the deterioration of proprioception over time. It is suggested that the losses in proprioception may result from the inability to properly regulate motor control and body reflexes. Therefore, the assessment of proprioception plays an important role in assessing changes in postural instability, gait and fall risk.

It is said that while peripheral muscle feedback is preserved in Parkinson's patients, there is deterioration in integration in the central. Changes in the supraspinal processing of proprioceptive input in PD have been demonstrated by analyzing the effect of mechanical vibration applied to the tendon of a stretched muscle during voluntary movements. Vibrator stimulation activates muscle spindle afferents, particularly primary endings. It is also stated that muscle feedback is not only related to the movement performed, but also to the response induced by vibration.

In line with this information, vibration applications have been added to the treatment of PD in recent years with the aim of stimulating postural adjustments through the application of an external proprioceptive input.

It is selectively used in neurological rehabilitation because of the effect of local vibration training on spinal excitability. When the literature is examined, it has been determined that the studies on the effects of local vibration applied to the neck region on posture, balance, proprioception and other sensory profiles are insufficient, especially in individuals with Parkinson's disease.

In this project, it is aimed to guide professionals working with Parkinson's disease in the management of this disease by determining the effects of cervical stabilization and local vibration application to the cervical region on motor symptoms and sensory profile in individuals with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

1. Being diagnosed with idiopathic Parkinson's Disease
2. To be between the ages of 40-80,
3. The duration of the disease is 3 years or more,
4. Being between stage 2 and 3 according to the Modified Hoehn-Yahr Staging Scale \[Modified Hoehn \& Yahr Staging Scale: This scale examines the disease in 5 stages (82). These phases are:

   * Stage 1: Unilateral tremor, rigidity, akinesia or postural instability.
   * Stage 1.5: Unilateral and axial involvement.
   * Stage 2: Postural abnormalities with or without axial signs such as bilateral tremor, rigidity, akinesia or bradymia, swallowing difficulties, axial rigidity (especially neck), forward-bending posture, slow or shuffling gait, and general stiffness
   * Stage 2.5: Mild bilateral disease with improvement in tensile test
   * Stage 3: In addition to the findings in Stage 2, the patient has balance disorder, but the patient can perform all activities independently.
   * Stage 4: The patient needs help in some or all activities of daily living.
   * Stage 5: The patient is wheelchair or bed-bound\].
5. A score of 24 or higher on the Standardized Mini-Mental test, Standardized Mini-Mental Test: There are 19 items in this test, which consists of 5 main sections: orientation, recording memory, attention and calculation, recall and language. The total score of the test is evaluated out of 30 and 24 points are accepted as the threshold value for the diagnosis of mild dementia (83).
6. Not have any additional orthopedic, vestibular and/or neurological disease other than Parkinson's Disease that will affect muscle strength, sense, balance and coordination.
7. Not having undergone any surgical procedure that may affect the stabilization of the musculoskeletal system of the spinal column and lower extremity.

Exclusion Criteria:

1. Having a pacemaker,
2. Having a psychiatric disease, uncontrollable dyskinesia or motor fluctuations, postural hypotension that may affect balance, vision problems,
3. Individuals with orthopedic problems that may cause limitation of movement and inflammatory arthritis (such as fractures, osteoporosis, osteomyelitis) will be excluded from the study.

Primary outcomes:
measure: Change of Recording Demographic Data
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Movement Disorders Association, Unified Parkinson's Disease Rating Scale
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of cervical region joint position sense
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Vibration Sense
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Light touch-Pressure Sense
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Craniocervical Flexion Strength
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Endurance Cervical Flexor Muscles
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Respiratory Muscle Strength
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Balance
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Functional Reach Test
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of New York Posture Analysis
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Basic Digital Inclinometer - Inclinometer
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Baseline Inclinometer
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Freezing Scale While Walking
timeFrame: baseline - change at 6 weeks - 4 weeks later
Secondary outcomes:
measure: Change of Timed Get Up and Go Test
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of 2 Minute Walk Test
timeFrame: baseline - change at 6 weeks - 4 weeks later
measure: Change of Parkinson's Disease Questionnaire-39
timeFrame: baseline - change at 6 weeks - 4 weeks later
Other outcomes:
Locations:
Study officials:
References: