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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dual task
Treadmill Training
Standard exercise programme
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring dual task, treadmill, cognitive rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Dual task

Single task

Control

Arm Description

Treadmill training + cognitive tasks + standard exercise programme

Treadmill training + standard exercise programme

Standard exercise programme

Outcomes

Primary Outcome Measures

10MWT
10 Meter Walk Test on comfortable speed
10MWT with cognitive tasks
10 Meter Walk Test with cognitive tasks
MoCA
Montreal Cognitive Assessment
TUG
Timed Up and Go Test

Secondary Outcome Measures

PDQ-39
Parkinson Disease Questionnaire 39
FES-I
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.
Stroop Test
Cognitive assessment for executive functions
FOGQ
Freezing of Gait Questionnaire
Falls Diary
Falls account

Full Information

First Posted
April 3, 2019
Last Updated
April 3, 2019
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03902990
Brief Title
The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease
Official Title
Effects of Dual Task Training And Treadmill Training on Physical and Cognitive Functions in Patients With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
dual task, treadmill, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual task
Arm Type
Experimental
Arm Description
Treadmill training + cognitive tasks + standard exercise programme
Arm Title
Single task
Arm Type
Active Comparator
Arm Description
Treadmill training + standard exercise programme
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard exercise programme
Intervention Type
Other
Intervention Name(s)
Dual task
Intervention Description
The patients in the dual task group received cognitive tasks during treadmill training sessions.
Intervention Type
Other
Intervention Name(s)
Treadmill Training
Intervention Description
Standard treadmill training
Intervention Type
Other
Intervention Name(s)
Standard exercise programme
Intervention Description
Standard exercise programme for Parkinson Disease
Primary Outcome Measure Information:
Title
10MWT
Description
10 Meter Walk Test on comfortable speed
Time Frame
12 weeks
Title
10MWT with cognitive tasks
Description
10 Meter Walk Test with cognitive tasks
Time Frame
12 weeks
Title
MoCA
Description
Montreal Cognitive Assessment
Time Frame
12 weeks
Title
TUG
Description
Timed Up and Go Test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PDQ-39
Description
Parkinson Disease Questionnaire 39
Time Frame
12 weeks
Title
FES-I
Description
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.
Time Frame
12 weeks
Title
Stroop Test
Description
Cognitive assessment for executive functions
Time Frame
12 weeks
Title
FOGQ
Description
Freezing of Gait Questionnaire
Time Frame
12 weeks
Title
Falls Diary
Description
Falls account
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Yaliman, Prof
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ekin Ilke Sen, MD
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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