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Clinical Trials/NCT01895608
NCT01895608CompletedNot Applicable

Cognitive Training and Dual-task Ability in Older Adults

VA Office of Research and Development2 sites in 1 country34 target enrollmentStarted: July 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
2
Primary Endpoint
Change Scores in Timed up and go With Cognitive Task

Study Overview

Brief Summary

The first goal of this study is to examine the extent to which the inclusion of dual-task practice to standard balance rehabilitation results in greater benefits to dual-task ability. The second goal of this study is to examine the extent to which the addition of cognitive training following balance rehabilitation results in greater benefits to dual-task ability.

Detailed Description

Historically, degradation of balance control in older adults has been attributed to impairments of the motor and/or sensory systems. As a result, therapy has focused on motor and sensory impairments. However, evidence suggests that an impaired ability to allocate attentional resources to balance during dual-task situations is a powerful predictor of falls. Despite this fact, few studies have examined whether interventions can improve older adults' dual-task ability. The goal of this study is to develop effective interventions to improve ability to allocate attention to balance and gait under dual-task conditions.

Older adults (n = 44) who have been referred to physical therapy (PT) for gait or balance impairments who have dual-task impairment will be randomized to receive either standard balance rehabilitation or balance rehabilitation with dual-task practice. Following PT, subjects will receive cognitive training (CT), either speed of processing or generalized cognitive training. Primary outcomes are ability to walk while performing four different cognitive tasks of varying difficulty. Assessment will occur at baseline, post-PT, post-CT.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Inclusion criteria include:
  • •> 60 years of age
  • •documented balance or mobility problems
  • •dual-task impairment (timed up and go with subtraction task > 15 s)

Exclusion Criteria

  • •Exclusion criteria include:
  • •cognitive impairment (> 2 errors on Short Portable Mental Status Questionnaire41)
  • •progressive medical issues that would impact mobility (e.g., Parkinson's disease).

Arms & Interventions

Balance rehabilitation + dual-tasking

Experimental

Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.

Intervention: Balance rehabilitation + dual-tasking (Behavioral)

Standard balance rehabilitation

Active Comparator

Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.

Intervention: Standard balance rehabilitation (Behavioral)

Cognitive training (speed of processing)

Experimental

Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.

Intervention: Cognitive training (speed of processing) (Behavioral)

Cognitive training (general cognition)

Active Comparator

General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.

Intervention: Cognitive training (general cognition) (Behavioral)

Outcomes

Primary Outcomes

Change Scores in Timed up and go With Cognitive Task

Time Frame: baseline and 6 weeks

Timed up and go test (TUG) has three conditions: no secondary task (TUG), cognitive (TUGc) and manual dual-tasks (TUG-m). Time to complete the task with the cognitive task was recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability.

Secondary Outcomes

  • Change Scores in Sensory Organization Test (SOT)(baseline and 6 weeks)
  • Change Scores in Activities-specific Balance-related Confidence(baseline and 6 weeks)
  • Change Scores in Preferred Gait Speed(baseline and 6 weeks)
  • Change Scores in Walk While Talk Test With Verbal Fluency Task(baseline and 6 weeks)
  • Change Scores in Dynamic Gait Index(baseline and 6 weeks)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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