The Effect of the Reaction Training in Parkinson's Disease

Not Applicable

Not yet recruiting

• Conditions: Parkinson' Disease

• Registration Number: NCT06807385
• Lead Sponsor: Gazi University

Brief Summary

Parkinson's disease (PD) is one of the most common neurodegenerative diseases. Patients frequently experience decreased amplitude and speed of movements, balance, and gait problems. Although the basal ganglia have been the target neuroanatomical region for movement disorders in Parkinson's disease for many years, recent neuroscience studies have shown that the cerebellum also plays an important role in the disease and is an important alternative target for treatment applications. While medical applications are becoming current for this purpose, there is a significant deficiency in the literature in terms of physiotherapy applications. Reaction and dual task are activities that have been shown to naturally stimulate the cerebellum. The aim of this study is to examine the effects of combined exercise training, which includes dual skills and reaction activities that have been shown to stimulate the cerebellum in PD, on the reaction time, intuitive postural adjustments, and balance of PD. Our study is an original study that targets the cerebellum in PD with reaction training according to current neuroscience results, aims to contribute to the field of neuroscience and translational medicine, and has no previous example in the literature. This study will include patients diagnosed with idiopathic Parkinson's disease by a specialist physician. The PD patients included in the study will be randomly divided into two groups. The reaction group will be applied a combined reaction training program consisting of 15 exercises, including a light reaction measurement and an exercise system. The conventional group will be applied an exercise program consisting of only 15 exercises without reaction training. The patients included in the study will be subjected to reaction time, amplitude of intuitive postural adjustments, balance, and functional mobility assessments before and after the training. The light reaction measurement and exercise system will be applied for the measurement of reaction time of the volunteers, the static-dynamic balance assessment device for the assessment of intuitive postural adjustments, the Berg Balance Scale and the static-dynamic balance assessment device for balance assessments, and the Timed Up and Go Test will be applied to assess functional mobility. At the end of the study, we aim to demonstrate the effect of combined exercise training targeting the cerebellum compared to conventional exercise training in Parkinson's patients, to create clinical outcomes for the inclusion of the cerebellum in more physiotherapy programs in Parkinson's disease, and to provide clinical outcomes for physiotherapists for a new exercise protocol, as well as making scientific contributions to the fields of translational medicine and neuroscience.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Study Start: 2025-02-17
• Primary Completion: 2026-02-17
• Study Completion: 2026-03-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Being diagnosed with "Parkinson's Disease" by a specialist neurologist according to the diagnostic criteria of the Movement Disorders Association
• Being between stages 1-3 according to the Hoehn and Yahr Staging
• Having additional neurological (migraine etc.), orthopedic (osteoarthritis etc.), cardiovascular (hypertension, benign arrhythmias etc.) diseases

Exclusion Criteria

• Having a Standardized Mini-Mental Test score of >25
• Having a visual or hearing impairment that cannot be corrected with a device
• Having additional neurological (migraine etc.), orthopedic (osteoarthritis etc.), cardiovascular (hypertension, benign arrhythmias etc.) diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postural Stability Assessment	Eight weeks	Quantitative assessment of balance, allows the assessment of postural oscillations in different conditions such as two legs and one leg stance positions. For this purpose, a force platform (K-Force Platform, K-İnvent®) will be used for postural oscillations in different conditions. It will be done in two-leg stance with eyes open, in two-leg stance with eyes closed, and in one-leg stance. Each test will be performed 3 times.
Anticipatory Postural Adjustments Assessment	Eight weeks	A force platform (K-Force Plate, K-İnvent) will be used to determine the amount of pressure center shift during the participants' stepping. Participants will be asked to stand on the force platform with their legs hip-width apart, in a posture as upright and stable as possible, and looking ahead at eye level. An audio stimulus will be used as a signal to start the movement. The measurement for the pressure center will be started 30 seconds before the signal to start the movement. Participants will be asked to stand in as upright and stable a position as possible for 30 seconds. At the end of 30 seconds, they will be asked to take the correct step first without waiting and as quickly as possible when they hear the audio stimulus. For the position analysis, the average and standard deviation of the positions in the 30-second standing position will be calculated.
Reaction Time Measurement	Eight weeks	Measurement of reaction time will be done with the light reaction measurement and exercise system (Blazepod®) to be provided within the scope of the project for visual stimulus reaction training. There are two different concepts for reaction time: simple and choice. Simple reaction time is defined as the time between a single stimulus given and a single response. Choice reaction time is defined as the time between multiple stimuli given to the person and the appropriate response to the stimulus.
Movement Disorder Socity-Unified Parkinson's Disease Rating Scale	Eight weeks	It was developed specifically for Parkinson's disease by Fahn and Elton in order to evaluate Parkinson's patients in terms of four clinical features. The scale, which includes a section for each clinical feature, consists of four sections in total. The first section consists of items that evaluate mental and emotional status (4 items); the second section includes items that evaluate daily living activities (13 items); the third section includes items that evaluate the severity of motor disorders (14 items); and the fourth section includes items that evaluate treatment-related complications (11 items). Scoring is done between zero and four in the total of 42 items in the scale, and a higher score indicates a more severe disorder. 0 points = Normal, 1 point = Slight, 2 points = Mild, 3 points = Moderate, 4 points = Severe. The validity and reliability of the Turkish version of the UPDRS were demonstrated in the study conducted by Akbostancı et al.

Secondary Outcome Measures

Name	Time	Method
Time Up and Go Test	Eight weeks	The functional mobility of the patients will be assessed with the Timed Up and Go Test (TWG). In the test, the patient is asked to get up from the chair with the "walk" command, walk 3 m, turn around, and then sit back on the chair. The test is performed on a 3-meter flat surface.
Berg Balance Scale	Eight weeks	Berg Balance Scale, which is used to assess static and proactive balance and consists of 14 items, is a functional test with high reliability and validity used in the assessment of balance and falls in elderly individuals. Each item is scored between 0 and 4. If the activity can be performed according to the instructions, 4 points are received from the scale items, and 0 points are received if it cannot be performed at all..

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey