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The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease

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ClinicalTrials.gov Identifier: NCT03902990
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tugce Kocamal, Istanbul University

Brief Summary:
The ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Dual task Other: Treadmill Training Other: Standard exercise programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this prospective, randomized, controlled, double-blinded study the patients were randomized to three groups as; dual-task group, single-task group and control group. All of the patients were scheduled on standard exercise programme. The patients in dual-task group received treadmill training with cognitive tasks and the patients in single-task group received treadmill training alone in addition to standard exercise programme. The training was scheduled as 30 minute sessions under supervision of a specialist, three times in a week for four weeks.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Dual Task Training And Treadmill Training on Physical and Cognitive Functions in Patients With Parkinson Disease
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dual task
Treadmill training + cognitive tasks + standard exercise programme
Other: Dual task
The patients in the dual task group received cognitive tasks during treadmill training sessions.

Other: Treadmill Training
Standard treadmill training

Other: Standard exercise programme
Standard exercise programme for Parkinson Disease

Active Comparator: Single task
Treadmill training + standard exercise programme
Other: Treadmill Training
Standard treadmill training

Other: Standard exercise programme
Standard exercise programme for Parkinson Disease

Active Comparator: Control
Standard exercise programme
Other: Standard exercise programme
Standard exercise programme for Parkinson Disease




Primary Outcome Measures :
  1. 10MWT [ Time Frame: 12 weeks ]
    10 Meter Walk Test on comfortable speed

  2. 10MWT with cognitive tasks [ Time Frame: 12 weeks ]
    10 Meter Walk Test with cognitive tasks

  3. MoCA [ Time Frame: 12 weeks ]
    Montreal Cognitive Assessment

  4. TUG [ Time Frame: 12 weeks ]
    Timed Up and Go Test


Secondary Outcome Measures :
  1. PDQ-39 [ Time Frame: 12 weeks ]
    Parkinson Disease Questionnaire 39

  2. FES-I [ Time Frame: 12 weeks ]
    To evaluate fear of falling, all patients filled the Falls Efficacy Scale-International (FES-I). A series of 16 questions assesses the respondent's fear of falling for a range of ADLs. Each question was rated on a four-point scale.

  3. Stroop Test [ Time Frame: 12 weeks ]
    Cognitive assessment for executive functions

  4. FOGQ [ Time Frame: 12 weeks ]
    Freezing of Gait Questionnaire

  5. Falls Diary [ Time Frame: 4 weeks ]
    Falls account



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The patients with Idiopathic Parkinson Disease on medication who has

  • Hoehn-Yahr 1-3
  • Mini Mental Test score 20 and above
  • Functional Ambulation Category 2 and above
  • No changes in medication in last 3 months
  • No rehabilitation programme in last 3 months

Exclusion Criteria:

  • Diagnosis of Parkinsonism other than Idiopathic Parkinson Disease
  • Global aphasia
  • Severe cognitive dysfunction
  • Other neurologic/orthopedic diseases
  • Limiting cardiovascular or pulmonary disease
  • Visual impairment
  • Hearing loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902990


Locations
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Turkey
Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Ayse Yaliman, Prof Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
Study Director: Ekin Ilke Sen, MD Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation

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Responsible Party: Tugce Kocamal, Assistant Doctor, Istanbul University
ClinicalTrials.gov Identifier: NCT03902990     History of Changes
Other Study ID Numbers: 20181443
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Tugce Kocamal, Istanbul University:
dual task, treadmill, cognitive rehabilitation

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases