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OpenTrials
Completed

NCT Number: NCT01568957

Training Dual-Task Walking After Stroke

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Gait training

Behavioral

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 outcomes

  1. Dual-task cost on gait speed

    Time frame: 4 weeks

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

Secondary outcomes

  1. Executive function

    Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention

    A computerized version of the Stroop task will be used to assess changes in executive function.

  2. Spontaneous physical activity

    Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention

    Spontaneous physical activity will be assessed with an activity monitor (PAMSys) worn for two consecutive days at each assessment timepoint.

  3. Kinematics of gait during obstacle crossing

    Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention

  4. Stroke Impact Scale

    Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • University of Arizona

Registry information

Official study title

Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Apr 2, 2012
Registry last updated
Dec 12, 2017

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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