Dual Task Training in Parkinson's Disease

NCT04115683 | Unknown

• 1 other identifier: 14.01.2019/35
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.

  8 weeks

• Unified Parkinson's Disease Rating Scale (UPDRS)

  8 weeks

• Berg Balance Scale (BBS)

  8 weeks

• One-legged Stance Test

  8 weeks

• Timed Up and Go (TUG) test

  8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Dual Task Training

Control Group

ACTIVE COMPARATOR

Other: Single Task Training

Interventions

Dual Task Training OTHER

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 Group

Single Task Training OTHER

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

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 40 years of age
• neurologist-diagnosed Parkinson's Disease
• Hoehn \& Yahr (H\&Y) stages 1 to 3
• or more mini mental status examination score.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences

Ankara, 06560, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Çağrı Gülşen, MSc

CONTACT

05555874415; fztcagri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 4, 2019
• Study Start: October 16, 2019
• Primary Completion: March 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)