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Dual Task Training in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dual Task Training
Single Task Training
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gazi University, Faculty of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
One-legged Stance Test
The duration participant is able to maintain their balance on one leg up to will be recorded.
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.
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.
Stroop Test
Stroop test will be used to test cognitive function.
Trail Making Test (TMT) Part A and B
The Trail Making Test is a measure of attention, speed and mental flexibility.
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.

Full Information

First Posted
September 30, 2019
Last Updated
November 15, 2019
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04115683
Brief Title
Dual Task Training in Parkinson's Disease
Official Title
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dual Task Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Single Task Training
Intervention Description
45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
Primary Outcome Measure Information:
Title
Balance-Postural Stability
Description
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.
Time Frame
8 weeks
Title
Balance- Limits of Stability
Description
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.
Time Frame
8 weeks
Title
Balance- Modified Sensory Organization Tests
Description
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.
Time Frame
8 weeks
Title
Gait Speed
Description
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.
Time Frame
8 weeks
Title
Cadence
Description
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.
Time Frame
8 weeks
Title
Stride width
Description
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.
Time Frame
8 weeks
Title
Stride length
Description
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.
Time Frame
8 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
8 weeks
Title
Change in brain derived neurotrophic factor (BDNF) levels of serum
Description
Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
8 weeks
Title
Change in vascular endothelial growth factor (VEGF) levels of serum
Description
Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
8 weeks
Title
Change in insulin like growth factor 1 (IGF-1) levels of serum
Description
Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
Description
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.
Time Frame
8 weeks
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
8 weeks
Title
Berg Balance Scale (BBS)
Description
Berg Balance Scale (BBS) is a scale that using for assess postural stability. It ranges 0-56 with higher score indicates better stability.
Time Frame
8 weeks
Title
One-legged Stance Test
Description
The duration participant is able to maintain their balance on one leg up to will be recorded.
Time Frame
8 weeks
Title
Timed Up and Go (TUG) test
Description
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.
Time Frame
8 weeks
Title
Activities-Specific Balance Confidence (ABC) Scale
Description
Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
Time Frame
8 weeks
Title
Stroop Test
Description
Stroop test will be used to test cognitive function.
Time Frame
8 weeks
Title
Trail Making Test (TMT) Part A and B
Description
The Trail Making Test is a measure of attention, speed and mental flexibility.
Time Frame
8 weeks
Title
Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Çağrı Gülşen, MSc
Phone
05555874415
Email
fztcagri@gmail.com
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Çağrı Gülşen
Phone
05555874415
Email
fztcagri@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Dual Task Training in Parkinson's Disease

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