Clinical trial NCT06807385: The Effect of the Reaction Training in Parkinson's Disease
Official title: Investigation of the Effect of the Reaction Training on Reaction Time, Anticipatory Postural Adjustment, and Balance in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson&#39; Disease
Keywords: balance
reaction time
postural adjustments
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postural Stability Assessment
timeFrame: Eight weeks
measure: Anticipatory Postural Adjustments Assessment
timeFrame: Eight weeks
measure: Reaction Time Measurement
timeFrame: Eight weeks
measure: Movement Disorder Socity-Unified Parkinson's Disease Rating Scale
timeFrame: Eight weeks
Secondary outcomes:
measure: Time Up and Go Test
timeFrame: Eight weeks
measure: Berg Balance Scale
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
citation: Lewis MM, Galley S, Johnson S, Stevenson J, Huang X, McKeown MJ. The role of the cerebellum in the pathophysiology of Parkinson's disease. Can J Neurol Sci. 2013 May;40(3):299-306. doi: 10.1017/s0317167100014232.
citation: Gündüz, A. G., Otman, A. S., Köse, N., Bilgin, S., & Elibol, B. (2009). Parkinson hastalığında farklı denge ölçeklerinin karşılaştırılması. Fizyoterapi Rehabilitasyon, 20(1), 17-24.
citation: Gao L, Zhang J, Hou Y, Hallett M, Chan P, Wu T. The cerebellum in dual-task performance in Parkinson's disease. Sci Rep. 2017 Mar 30;7:45662. doi: 10.1038/srep45662.
citation: Lupinacci NS, Rikli RE, Jones CJ, Ross D. Age and physical activity effects on reaction time and digit symbol substitution performance in cognitively active adults. Res Q Exerc Sport. 1993 Jun;64(2):144-50. doi: 10.1080/02701367.1993.10608791.
citation: Akbostanci MC, Bayram E, Yilmaz V, Rzayev S, Ozkan S, Tokcaer AB, Saka E, Durmaz Celik FN, Barut BO, Tufekcioglu Z, Acarer A, Balaban H, Erer S, Dogu O, Kibaroglu S, Aydin N, Hanagasi H, Elibol B, Emre M, Stebbins GT, Goetz CG. Turkish Standardization of Movement Disorders Society Unified Parkinson's Disease Rating Scale and Unified Dyskinesia Rating Scale. Mov Disord Clin Pract. 2017 Nov 16;5(1):54-59. doi: 10.1002/mdc3.12556. eCollection 2018 Jan-Feb.