Walking While Talking: The Effect of Doing Two Things at Once in Individuals With Neurological Injury or Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01917903
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2013
Last Update Posted : November 10, 2016
Information provided by (Responsible Party):
Lisa Muratori, Stony Brook University

Brief Summary:
This study will evaluate gait when individuals with Parkinson's disease (PD) are walking while talking to see how walking changes when challenged to perform a functional cognitive task simultaneously. By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD. Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty. Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention. The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Huntington's Disease Multiple Sclerosis Traumatic Brain Injury Behavioral: Gait-cognitive training Behavioral: Identification of at risk variables Not Applicable

Detailed Description:
In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone. Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking. During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into one of the three training groups and asked to come to the lab three times a week for four weeks during the intervention. One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit. The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Walking While Talking: The Effects of Dual Task on Gait and Cognition in Individuals With Neurological Injury or Disease.
Study Start Date : April 2013
Estimated Primary Completion Date : April 2020

Arm Intervention/treatment
Experimental: Identification of at risk variables
Individuals will come in for a single visit to perform all tasks / conditions. Measurements will be taken of spatial and temporal features of walking with and without a secondary task. In addition, cognitive tests of memory and attention will be performed. Outcomes will narrow measures to those most likely to show clinically significant change.
Behavioral: Identification of at risk variables
Participants will complete walking under three conditions: walking alone, walking while talking to an investigator in person, and walking while talking to an investigator on a cell phone. Spatiotemporal measures of gait will be collected.

Experimental: Gait-Cognitive training
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
Behavioral: Gait-cognitive training
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.

Primary Outcome Measures :
  1. Spatiotemporal measures of gait across conditions and over time. [ Time Frame: Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training) ]
    Changes in gait parameters are a key measure of the difficulty of performing two tasks at once. Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.

Secondary Outcome Measures :
  1. Changes in cognitive performance measured with serial sevens. [ Time Frame: Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training) ]
    Participants will count backward by sevens from a digit between 90 and 100. The ability to perform the task will be used as a measure of cognitive trade-off relative to walking performance.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's disease, mild traumatic brain injury, multiple sclerosis or Huntington's disease
  • ambulatory for at least 200 feet without an assistive device (cane, walker, etc)

Exclusion Criteria:

  • recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
  • concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
  • cardiac insufficiency limiting ability to participate in walking study

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 identifier (NCT number): NCT01917903

United States, New York
Stony Brook University RRAMP Laboratory
Stony Brook, New York, United States, 11794-6018
Sponsors and Collaborators
Stony Brook University
Principal Investigator: Lisa M Muratori Stony Brook University

Responsible Party: Lisa Muratori, Associate Professor, Stony Brook University Identifier: NCT01917903     History of Changes
Other Study ID Numbers: 64249
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016

Keywords provided by Lisa Muratori, Stony Brook University:
Parkinson's disease
traumatic brain injury
multiple sclerosis
physical therapy

Additional relevant MeSH terms:
Wounds and Injuries
Parkinson Disease
Multiple Sclerosis
Brain Injuries
Brain Injuries, Traumatic
Huntington Disease
Trauma, Nervous System
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Craniocerebral Trauma
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders