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Training Dual-Task Walking After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait training
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Gait, Dual-task, Obstacle avoidance, Attention allocation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Within 3 years 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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual-task gait training

Single-task gait training

Arm Description

Gait training with simultaneous performance of cognitive tasks for 75% of training session.

Gait training (without simultaneous cognitive task performance)

Outcomes

Primary Outcome Measures

Dual-task cost on gait speed
The dual-task cost represents the difference between single and dual-task walking speed.

Secondary Outcome Measures

Executive function
A computerized version of the Stroop task will be used to assess changes in executive function.
Spontaneous physical activity
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
Stroke Impact Scale

Full Information

First Posted
March 25, 2012
Last Updated
December 8, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT01568957
Brief Title
Training Dual-Task Walking After Stroke
Official Title
Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 29, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Arizona

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Gait, Dual-task, Obstacle avoidance, Attention allocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-task gait training
Arm Type
Experimental
Arm Description
Gait training with simultaneous performance of cognitive tasks for 75% of training session.
Arm Title
Single-task gait training
Arm Type
Active Comparator
Arm Description
Gait training (without simultaneous cognitive task performance)
Intervention Type
Behavioral
Intervention Name(s)
Gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dual-task cost on gait speed
Description
The dual-task cost represents the difference between single and dual-task walking speed.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Executive function
Description
A computerized version of the Stroop task will be used to assess changes in executive function.
Time Frame
Measured at baseline, post intervention (4 weeks), 6 months post intervention
Title
Spontaneous physical activity
Description
Spontaneous physical activity will be assessed with an activity monitor (PAMSys) worn for two consecutive days at each assessment timepoint.
Time Frame
Measured at baseline, post intervention (4 weeks), 6 months post intervention
Title
Kinematics of gait during obstacle crossing
Time Frame
Measured at baseline, post intervention (4 weeks), 6 months post intervention
Title
Stroke Impact Scale
Time Frame
Measured at baseline, post intervention (4 weeks), 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Within 3 years 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prudence Plummer, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23113928
Citation
Plummer-D'Amato P, Kyvelidou A, Sternad D, Najafi B, Villalobos RM, Zurakowski D. Training dual-task walking in community-dwelling adults within 1 year of stroke: a protocol for a single-blind randomized controlled trial. BMC Neurol. 2012 Oct 31;12:129. doi: 10.1186/1471-2377-12-129.
Results Reference
derived

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Training Dual-Task Walking After Stroke

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