Training Dual-Task Walking After Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northeastern University
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Prudence Plummer-D'Amato, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01568957
First received: March 25, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).


Condition Intervention
Stroke
Behavioral: Gait training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control

Further study details as provided by Northeastern University:

Primary Outcome Measures:
  • Dual-task cost on gait speed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The dual-task cost represents the difference between single and dual-task walking speed.


Secondary Outcome Measures:
  • Executive function [ Time Frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention ] [ Designated as safety issue: No ]
    A computerized version of the Stroop task will be used to assess changes in executive function.

  • Spontaneous physical activity [ Time Frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention ] [ Designated as safety issue: No ]
    Spontaneous physical activity will be assessed with an activity monitor (PAMSys) worn for two consecutive days at each assessment timepoint.

  • Kinematics of gait during obstacle crossing [ Time Frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual-task gait training
Gait training with simultaneous performance of cognitive tasks for 75% of training session.
Behavioral: Gait training
Twelve 30-minute sessions plus 10-minute stretching and warm up, provided 3 times per weeks for 4 weeks. Up to 6 weeks are allowed to complete the 12 sessions.
Active Comparator: Single-task gait training
Gait training (without simultaneous cognitive task performance)
Behavioral: Gait training
Twelve 30-minute sessions plus 10-minute stretching and warm up, provided 3 times per weeks for 4 weeks. Up to 6 weeks are allowed to complete the 12 sessions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Within 12 months of stroke onset
  • Living in the community, operationally defined as living in one's own home, or the home of a friend, relative, or caregiver
  • Walking speed 0.6-1.1 m/s determined during 10-meter walk test
  • Walk without the assistance of another person
  • Medically stable and approved for participation by study physician
  • Intact global cognition indicated by score > 23 on Montreal Cognitive Assessment
  • Living in the community prior to stroke

Exclusion Criteria:

  • Pre-existing neurological disorders (e.g., Parkinson's disease, Multiple Sclerosis, dementia, traumatic brain injury)
  • Previous stroke with residual motor deficit
  • Uncontrolled hypertension
  • Inability to follow 3-step command
  • Primary uncontrolled hearing impairment
  • Severe uncontrolled visual impairment
  • Any speech-language impairment affecting ability to respond verbally to auditory stimuli
  • Timed Up and Go test > 15 seconds
  • Lower extremity amputation
  • Any orthopedic problem affecting gait
  • Concurrent participation in another clinical trial
  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: NCT01568957

Contacts
Contact: Prudence Plummer, PhD 919-843-8658 pplummer@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Prudence Plummer, PhD    919-843-8658    pplummer@med.unc.edu   
Principal Investigator: Prudence Plummer, PhD         
Sponsors and Collaborators
Northeastern University
University of Arizona
Investigators
Principal Investigator: Prudence Plummer-D'Amato, PhD Northeastern University
  More Information

No publications provided

Responsible Party: Prudence Plummer-D'Amato, Assistant Professor of Physical Therapy, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01568957     History of Changes
Other Study ID Numbers: 11SDG7270001
Study First Received: March 25, 2012
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northeastern University:
Gait
Dual-task
Obstacle avoidance
Attention allocation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014