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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

Tracking Information
First Submitted Date  ICMJE August 17, 2015
First Posted Date  ICMJE September 2, 2015
Results First Submitted Date  ICMJE July 16, 2018
Results First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 3, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Step length during gait [ Time Frame: Phase 1: baseline ]
  • Step length during gait [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
  • Walking speed during gait [ Time Frame: Phase 1: baseline ]
  • Walking speed during gait [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • 2 Minute Walk Test [ Time Frame: Phase 1: baseline ]
  • 2 Minute Walk Test [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
  • Limits of Stability test [ Time Frame: Phase 1: baseline ]
  • Limits of Stability test [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
  • Quality of Life in Neurological Disorders questionnaire [ Time Frame: Phase 1: baseline ]
  • Quality of Life in Neurological Disorders questionnaire [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
  • Activities-specific Balance Confidence Scale [ Time Frame: Phase 1: baseline ]
  • Activities-specific Balance Confidence Scale [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
  • Trail Making Test [ Time Frame: Phase 1: baseline ]
  • Trail Making Test [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
  • Reaction Time [ Time Frame: Phase 1: baseline ]
  • Reaction Time [ Time Frame: Phase 2: change from baseline to end of 8 week intervention and change from baseline to 4 weeks after the intervention ends ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Dual Task Training in Individuals With Parkinson's Disease
Official Title  ICMJE The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Behavioral: Dual Task Group
    Performing motor-motor or motor-cognitive tasks at the same time.
  • Behavioral: Single Task Group
    Performing motor or cognitive tasks alone.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Dual Task Group
  • 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.
    Intervention: Behavioral: Single Task Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
45
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
35
Actual Study Completion Date  ICMJE August 16, 2017
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02538029
Other Study ID Numbers  ICMJE 15-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jay Alberts, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Davis Phinney Foundation
Investigators  ICMJE
Principal Investigator: Jay Alberts, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP