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The Effects of Dual Task Training in Individuals With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02538029
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Davis Phinney Foundation
Information provided by (Responsible Party):
Jay Alberts, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Dual Task Group Behavioral: Single Task Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease
Study Start Date : August 2015
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dual Task Group
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.
Behavioral: Dual Task Group
Performing motor-motor or motor-cognitive tasks at the same time.

Active Comparator: Single Task Group
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.
Behavioral: Single Task Group
Performing motor or cognitive tasks alone.




Primary Outcome Measures :
  1. Step Length During Gait [ Time Frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    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.

  2. Walking Speed During Gait [ Time Frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    Average self-selected walking speed without dual tasking.


Secondary Outcome Measures :
  1. 2 Minute Walk Test [ Time Frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.

  2. Quality of Life in Neurological Disorders Questionnaire [ Time Frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    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.

  3. Activities-specific Balance Confidence Scale [ Time Frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.

  4. Trail Making Test [ Time Frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    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.

  5. Reaction Time [ Time Frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks ]
    Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02538029


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Davis Phinney Foundation
Investigators
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Principal Investigator: Jay Alberts, PhD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Jay Alberts, The Cleveland Clinic:
Study Protocol  [PDF] September 6, 2016
Statistical Analysis Plan  [PDF] January 31, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jay Alberts, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02538029    
Other Study ID Numbers: 15-1000
First Posted: September 2, 2015    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jay Alberts, The Cleveland Clinic:
Dual tasking
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
Synucleinopathies
Neurodegenerative Diseases