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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Stony Brook University
Sponsor:
Information provided by (Responsible Party):
Lisa Muratori, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01917903
First received: July 30, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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 Intervention
Parkinson's Disease
Huntington's Disease
Multiple Sclerosis
Traumatic Brain Injury
Behavioral: Gait-cognitive training
Behavioral: Identification of at risk variables

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HEALTHY VOLUNTEERS OR
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917903

Contacts
Contact: Lisa M Muratori, PT, EdD 6314446583 lisa.muratori@stonybrook.edu

Locations
United States, New York
Stony Brook University RRAMP Laboratory Recruiting
Stony Brook, New York, United States, 11794-6018
Contact: Lisa Muratori, PT, EdD    631-444-6583    lisa.muratori@stonybrook.edu   
Principal Investigator: Lisa Muratori, PT, EdD         
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Lisa M Muratori Stony Brook University
  More Information

No publications provided

Responsible Party: Lisa Muratori, Clinical Associate Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT01917903     History of Changes
Other Study ID Numbers: 64249
Study First Received: July 30, 2013
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
walking
Parkinson's disease
traumatic brain injury
multiple sclerosis
physical therapy
falls
memory
attention
multitasking
exercise

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

ClinicalTrials.gov processed this record on October 21, 2014