Dual Task Training in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.

Detailed Description
-----------------
20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group. And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks. Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks. In order to evaluate the effects of the training, evaluations will be performed before and after the training period.

Official Title
-----------------
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Dual Task Training
* Other: Single Task Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 40 years of age neurologist-diagnosed Parkinson's Disease Hoehn & Yahr (H&Y) stages 1 to 3 24 or more mini mental status examination score. Exclusion Criteria: other neurologic disorder cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program had deep brain stimulation history visual, auditory, orientational problems that could affect study results

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Other: Dual Task Training<br>* 45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.<br>|
| Active Comparator: Control Group<br> | Other: Single Task Training<br>* 45 minutes of single task training consisting of same motor activities (walking, balance... etc.)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance-Postural Stability | Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately. Total stability index score will obtained as the test result. | 8 weeks | 
| Balance- Limits of Stability | Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position. Total direction control score will obtained as the test result. | 8 weeks | 
| Balance- Modified Sensory Organization Tests | Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position. It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface. Stability index scores will obtained as the test result. | 8 weeks | 
| Gait Speed | Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed. | 8 weeks | 
| Cadence | Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed. | 8 weeks | 
| Stride width | Stride width will be evaluated by using the BTS-G Walk system and recorded as meters. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed. | 8 weeks | 
| Stride length | Stride length will be evaluated by using the BTS-G Walk system and recorded as meters. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed. | 8 weeks | 
| Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes. | 8 weeks | 
| Change in brain derived neurotrophic factor (BDNF) levels of serum | Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit. | 8 weeks | 
| Change in vascular endothelial growth factor (VEGF) levels of serum | Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit. | 8 weeks | 
| Change in insulin like growth factor 1 (IGF-1) levels of serum | Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoehn and Yahr Scale for level of physical disability in Parkinson's disease. | Hoehn and Yahr Scale is measures level of physical disability in Parkinson's disease and stages patients between level 1 level 5. Higher level indicates worse physical condition. | 8 weeks | 
| Unified Parkinson's Disease Rating Scale (UPDRS) | The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment). Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score. The UPDRS total score ranges between 0 and 199 points. Higher points indicates worse outcome. | 8 weeks | 
| Berg Balance Scale (BBS) | Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability. | 8 weeks | 
| One-legged Stance Test | The duration participant is able to maintain their balance on one leg up to will be recorded. | 8 weeks | 
| Timed Up and Go (TUG) test | Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again. | 8 weeks | 
| Activities-Specific Balance Confidence (ABC) Scale | Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady. | 8 weeks | 
| Stroop Test | Stroop test will be used to test cognitive function. | 8 weeks | 
| Trail Making Test (TMT) Part A and B | The Trail Making Test is a measure of attention, speed and mental flexibility. | 8 weeks | 
| Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) | The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total score ranges from 0 to 32. Higher scores indicates poorer quality of life. | 8 weeks |