Dual Task Training in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04115683
• Other study ID #: 14.01.2019/35
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2019
• Source: Gazi University
• Contact: Çagri Gülsen, MSc
• Phone: 05555874415
• Email: fztcagri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• Single Task Training
45 minutes of single task training consisting of same motor activities (walking, balance... etc.)

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	One-legged Stance Test	The duration participant is able to maintain their balance on one leg up to will be recorded.	8 weeks
Secondary	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
Secondary	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
Secondary	Stroop Test	Stroop test will be used to test cognitive function.	8 weeks
Secondary	Trail Making Test (TMT) Part A and B	The Trail Making Test is a measure of attention, speed and mental flexibility.	8 weeks
Secondary	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