NCT01568957

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

5.6 years

First QC Date

March 25, 2012

Last Update Submit

December 8, 2017

Conditions

Keywords

GaitDual-taskObstacle avoidanceAttention allocation

Outcome Measures

Primary Outcomes (1)

  • Dual-task cost on gait speed

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

    4 weeks

Secondary Outcomes (4)

  • Executive function

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

  • Spontaneous physical activity

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

  • Kinematics of gait during obstacle crossing

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

  • Stroke Impact Scale

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

Study Arms (2)

Dual-task gait training

EXPERIMENTAL

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

Behavioral: Gait training

Single-task gait training

ACTIVE COMPARATOR

Gait training (without simultaneous cognitive task performance)

Behavioral: Gait training

Interventions

Gait trainingBEHAVIORAL

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.

Dual-task gait trainingSingle-task gait training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Prudence Plummer, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2012

First Posted

April 2, 2012

Study Start

September 1, 2011

Primary Completion

March 29, 2017

Study Completion

November 15, 2017

Last Updated

December 12, 2017

Record last verified: 2017-11

Locations