- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902990
The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease
April 3, 2019 updated by: Tugce Kocamal, Istanbul University
Effects of Dual Task Training And Treadmill Training on Physical and Cognitive Functions in Patients With Parkinson Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey, 34093
- Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual task
Treadmill training + cognitive tasks + standard exercise programme
|
The patients in the dual task group received cognitive tasks during treadmill training sessions.
Standard treadmill training
Standard exercise programme for Parkinson Disease
|
|
Active Comparator: Single task
Treadmill training + standard exercise programme
|
Standard treadmill training
Standard exercise programme for Parkinson Disease
|
|
Active Comparator: Control
Standard exercise programme
|
Standard exercise programme for Parkinson Disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10MWT
Time Frame: 12 weeks
|
10 Meter Walk Test on comfortable speed
|
12 weeks
|
|
10MWT with cognitive tasks
Time Frame: 12 weeks
|
10 Meter Walk Test with cognitive tasks
|
12 weeks
|
|
MoCA
Time Frame: 12 weeks
|
Montreal Cognitive Assessment
|
12 weeks
|
|
TUG
Time Frame: 12 weeks
|
Timed Up and Go Test
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PDQ-39
Time Frame: 12 weeks
|
Parkinson Disease Questionnaire 39
|
12 weeks
|
|
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.
|
12 weeks
|
|
Stroop Test
Time Frame: 12 weeks
|
Cognitive assessment for executive functions
|
12 weeks
|
|
FOGQ
Time Frame: 12 weeks
|
Freezing of Gait Questionnaire
|
12 weeks
|
|
Falls Diary
Time Frame: 4 weeks
|
Falls account
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
April 3, 2019
First Submitted That Met QC Criteria
April 3, 2019
First Posted (Actual)
April 4, 2019
Study Record Updates
Last Update Posted (Actual)
April 5, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20181443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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