- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807385
The Effect of the Reaction Training in Parkinson's Disease
Investigation of the Effect of the Reaction Training on Reaction Time, Anticipatory Postural Adjustment, and Balance in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Gazi University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Reaction Training Group
In this group, we will use a reaction training and measurement system (Blazepod) for visual stimuli reaction training.
Each exercise duration will be three minutes.
The experimental group will apply reaction training two times a week for eight weeks.
Each session will complet in 60 minutes.
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Active Comparator: Control Group
The exercises used in reaction training will be applied as in conventional training without visual aids.
The difficulty of the exercise will be increased by changing the support surface and ground properties, taking the difficulty perceived by the individual as the criterion, as in reaction training.
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The exercises used in reaction training will be applied as in conventional training without reaction training system. The difficulty of the exercise will be increased by changing the support surface and ground properties, taking the difficulty perceived by the individual as the criterion, as in reaction training. The exercise list consists of 15 different exercises that aim to improve stability with upper and lower extremity movements in different positions. In addition, the program includes both dual motor tasks and difficulties that require the physiotherapist to give the patient constantly changing motor tasks and a second cognitive task. Each station will be worked for 3 minutes, with at least 1 minute of rest between stations. Sessions will be planned by selecting the exercises in the exercise list for 60 minutes. Appropriate modifications will be made to the station so that the difficulty of the exercise in the relevant station will be moderate (12-15 points for Borg Scale). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Stability Assessment
Time Frame: 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.
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Eight weeks
|
|
Anticipatory Postural Adjustments Assessment
Time Frame: 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.
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Eight weeks
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Reaction Time Measurement
Time Frame: Eight weeks
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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.
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Eight weeks
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Movement Disorder Socity-Unified Parkinson's Disease Rating Scale
Time Frame: Eight weeks
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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.
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Eight weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time Up and Go Test
Time Frame: 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.
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Eight weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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