Dual Task Training in Parkinson's Disease

November 15, 2019 updated by: Çağrı Gülşen, Gazi University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Recruiting
        • Gazi University, Faculty of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Intervention Group
Other: Dual Task Training
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.
Active Comparator: Control Group
Other: Single Task Training
45 minutes of single task training consisting of same motor activities (walking, balance... etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance-Postural Stability
Time Frame: 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.
8 weeks
Balance- Limits of Stability
Time Frame: 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.
8 weeks
Balance- Modified Sensory Organization Tests
Time Frame: 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.
8 weeks
Gait Speed
Time Frame: 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.
8 weeks
Cadence
Time Frame: 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.
8 weeks
Stride width
Time Frame: 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.
8 weeks
Stride length
Time Frame: 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.
8 weeks
Montreal Cognitive Assessment (MoCA)
Time Frame: 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.
8 weeks
Change in brain derived neurotrophic factor (BDNF) levels of serum
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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.
Time Frame: 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.
8 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 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.
8 weeks
Berg Balance Scale (BBS)
Time Frame: 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.
8 weeks
One-legged Stance Test
Time Frame: 8 weeks
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 Frame: 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.
8 weeks
Activities-Specific Balance Confidence (ABC) Scale
Time Frame: 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.
8 weeks
Stroop Test
Time Frame: 8 weeks
Stroop test will be used to test cognitive function.
8 weeks
Trail Making Test (TMT) Part A and B
Time Frame: 8 weeks
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)
Time Frame: 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2019

Primary Completion (Anticipated)

March 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.01.2019/35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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