Training Dual-Task Walking After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568957
• Other study ID #: 11SDG7270001
• Status: Completed
• Phase: N/A
• First received: March 25, 2012
• Last updated: December 8, 2017
• Start date: September 2011
• Est. completion date: November 15, 2017

Study information

• Verified date: November 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 15, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual-task cost on gait speed	The dual-task cost represents the difference between single and dual-task walking speed.	4 weeks
Secondary	Executive function	A computerized version of the Stroop task will be used to assess changes in executive function.	Measured at baseline, post intervention (4 weeks), 6 months post intervention
Secondary	Spontaneous physical activity	Spontaneous physical activity will be assessed with an activity monitor (PAMSys) worn for two consecutive days at each assessment timepoint.	Measured at baseline, post intervention (4 weeks), 6 months post intervention
Secondary	Kinematics of gait during obstacle crossing		Measured at baseline, post intervention (4 weeks), 6 months post intervention
Secondary	Stroke Impact Scale		Measured at baseline, post intervention (4 weeks), 6 months post intervention