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Completed

NCT Number: NCT02538029

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual Task Group

Behavioral

Performing motor-motor or motor-cognitive tasks at the same time.

Single Task Group

Behavioral

Performing motor or cognitive tasks alone.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Davis Phinney Foundation

Registry information

Official study title

The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2015
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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