Dual Task Training in Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: Single Task Training; Other: Dual Task Training

• Registration Number: NCT04115683
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Study Start: 2019-10-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

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

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Single Task Training	-
Intervention Group	Dual Task Training	-

Primary Outcome Measures

Name	Time	Method
Balance-Postural Stability	8 weeks	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.
Montreal Cognitive Assessment (MoCA)	8 weeks	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.
Balance- Limits of Stability	8 weeks	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.
Balance- Modified Sensory Organization Tests	8 weeks	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.
Gait Speed	8 weeks	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.
Cadence	8 weeks	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.
Stride width	8 weeks	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.
Stride length	8 weeks	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.
Change in insulin like growth factor 1 (IGF-1) levels of serum	8 weeks	Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Change in brain derived neurotrophic factor (BDNF) levels of serum	8 weeks	Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Change in vascular endothelial growth factor (VEGF) levels of serum	8 weeks	Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.

Secondary Outcome Measures

Name	Time	Method
Stroop Test	8 weeks	Stroop test will be used to test cognitive function.
One-legged Stance Test	8 weeks	The duration participant is able to maintain their balance on one leg up to will be recorded.
Timed Up and Go (TUG) test	8 weeks	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.
Activities-Specific Balance Confidence (ABC) Scale	8 weeks	Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
Trail Making Test (TMT) Part A and B	8 weeks	The Trail Making Test is a measure of attention, speed and mental flexibility.
Unified Parkinson's Disease Rating Scale (UPDRS)	8 weeks	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.
Berg Balance Scale (BBS)	8 weeks	Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability.
Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)	8 weeks	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.
Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.	8 weeks	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.

Trial Locations

Locations (1)

Gazi University, Faculty of Health Sciences; 🇹🇷 Ankara, Turkey