The Effects of Dual Task Training in Individuals With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual Task Group
Single Task Group
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Dual tasking
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of idiopathic PD
- Able to provide informed consent
- Ability to ambulate ≥ 300ft with or without an assistive device
- Hoehn and Yahr stage 2-4
Exclusion Criteria:
- Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
- Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
- Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
- Inability to follow 2 step commands
- Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual Task Group
Single Task Group
Arm Description
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
Outcomes
Primary Outcome Measures
Step Length During Gait
The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length.
Walking Speed During Gait
Average self-selected walking speed without dual tasking.
Secondary Outcome Measures
2 Minute Walk Test
A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.
Quality of Life in Neurological Disorders Questionnaire
Quality of life questionnaire. Reported here is T-Score for the Lower Extremity domain. A T-score of 50 is the mean of the reference population, with higher scores indicating a better outcome.
Activities-specific Balance Confidence Scale
Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.
Trail Making Test
Cognitive task where the participant connects 25 dots in numerical order. Lower scores indicate better cognitive function. Reported here is total time to complete the task.
Reaction Time
Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.
Full Information
NCT ID
NCT02538029
First Posted
August 17, 2015
Last Updated
February 4, 2019
Sponsor
The Cleveland Clinic
Collaborators
Davis Phinney Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02538029
Brief Title
The Effects of Dual Task Training in Individuals With Parkinson's Disease
Official Title
The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Davis Phinney Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Dual tasking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual Task Group
Arm Type
Experimental
Arm Description
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
Arm Title
Single Task Group
Arm Type
Active Comparator
Arm Description
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Dual Task Group
Intervention Description
Performing motor-motor or motor-cognitive tasks at the same time.
Intervention Type
Behavioral
Intervention Name(s)
Single Task Group
Intervention Description
Performing motor or cognitive tasks alone.
Primary Outcome Measure Information:
Title
Step Length During Gait
Description
The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length.
Time Frame
Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Title
Walking Speed During Gait
Description
Average self-selected walking speed without dual tasking.
Time Frame
Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Secondary Outcome Measure Information:
Title
2 Minute Walk Test
Description
A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.
Time Frame
Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Title
Quality of Life in Neurological Disorders Questionnaire
Description
Quality of life questionnaire. Reported here is T-Score for the Lower Extremity domain. A T-score of 50 is the mean of the reference population, with higher scores indicating a better outcome.
Time Frame
Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Title
Activities-specific Balance Confidence Scale
Description
Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.
Time Frame
Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Title
Trail Making Test
Description
Cognitive task where the participant connects 25 dots in numerical order. Lower scores indicate better cognitive function. Reported here is total time to complete the task.
Time Frame
Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Title
Reaction Time
Description
Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.
Time Frame
Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of idiopathic PD
Able to provide informed consent
Ability to ambulate ≥ 300ft with or without an assistive device
Hoehn and Yahr stage 2-4
Exclusion Criteria:
Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
Inability to follow 2 step commands
Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Alberts, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31648204
Citation
Penko AL, Barkley JE, Rosenfeldt AB, Alberts JL. Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease. J Phys Act Health. 2019 Dec 1;16(12):1085-1091. doi: 10.1123/jpah.2018-0595. Epub 2019 Oct 24.
Results Reference
derived
PubMed Identifier
31103489
Citation
Rosenfeldt AB, Penko AL, Streicher MC, Zimmerman NM, Koop MM, Alberts JL. Improvements in temporal and postural aspects of gait vary following single- and multi-modal training in individuals with Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:280-285. doi: 10.1016/j.parkreldis.2019.05.021. Epub 2019 May 14.
Results Reference
derived
PubMed Identifier
31034314
Citation
Rosenfeldt AB, Penko AL, Bazyk AS, Streicher MC, Dey T, Alberts JL. The Two Minute Walk Test Overground and on a Self-Paced Treadmill Detects Dual Task Deficits in Individuals With Parkinson's Disease. J Aging Phys Act. 2019 Dec 1;27(4):843-847. doi: 10.1123/japa.2018-0264.
Results Reference
derived
Learn more about this trial
The Effects of Dual Task Training in Individuals With Parkinson's Disease
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