Dual Task Training in Parkinson's Disease

Sponsor
Gazi University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04115683
Collaborator
(none)
20
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20.5
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dual Task Training
  • Other: Single Task Training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease
Actual Study Start Date :
Oct 16, 2019
Anticipated Primary Completion Date :
Mar 30, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

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.)

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. One-legged Stance Test [8 weeks]

    The duration participant is able to maintain their balance on one leg up to will be recorded.

  5. 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.

  6. 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.

  7. Stroop Test [8 weeks]

    Stroop test will be used to test cognitive function.

  8. Trail Making Test (TMT) Part A and B [8 weeks]

    The Trail Making Test is a measure of attention, speed and mental flexibility.

  9. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University, Faculty of Health Sciences Ankara Turkey 06560

Sponsors and Collaborators

  • Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Çağrı Gülşen, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier:
NCT04115683
Other Study ID Numbers:
  • 14.01.2019/35
First Posted:
Oct 4, 2019
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2019