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Completed

NCT Number: NCT01895608

Cognitive Training and Dual-task Ability

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.

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Key information

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Balance rehabilitation + dual-tasking

Behavioral

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

Standard balance rehabilitation

Behavioral

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

Cognitive training (speed of processing)

Behavioral

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.

Cognitive training (general cognition)

Behavioral

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.

Primary outcomes

  1. 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

  1. Change Scores in Walk While Talk Test With Verbal Fluency Task

    Time frame: baseline and 6 weeks

    The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.

  2. Change Scores in Dynamic Gait Index

    Time frame: baseline and 6 weeks

    Dynamic Gait Index (DGI) assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability.

    Each of the 8 conditions is scored on a scale from 0 (indicating severe impairment) to 3 (indicating normal ability). The total score is used for statistical analysis with a maximum score of 24 and a minimum score of 0 with a higher score indicating better performance. A total DGI score less than 20 out of 24 indicates fall risk.

  3. Change Scores in Sensory Organization Test (SOT)

    Time frame: baseline and 6 weeks

    SOT is organized into a series of 6 conditions of increasing difficulty: 3 involve a firm surface with eyes open, eyes closed and with vision sway-referenced and 3 involve a sway-referenced surface with eyes open, eyes closed, and with vision sway-referenced. SOT has good reliability and differentiates fallers and nonfallers.

    The SOT composite score is used for statistical analysis with a maximum score of 100 (indicating perfect stability) and a minimum score of 0 (indicating severe instability). Higher scores indicate better performance (i.e., greater postural stability) and SOT composite scores less than 38 out of 100 indicate fall risk.

  4. Change Scores in Preferred Gait Speed

    Time frame: baseline and 6 weeks

    Subjects walk at their preferred speed and time to walk 6 m is recorded.

  5. Change Scores in Activities-specific Balance-related Confidence

    Time frame: baseline and 6 weeks

    Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability. Sixteen activities are each assessed on a scale ranging from 0 to 100, where higher scores indicate greater confidence in performing the activity. Item scores are averaged to arrive at a final score, where average scores <67% indicate a greater fall risk.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Cognitive Training and Dual-task Ability in Older Adults

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2013
Registry last updated
Jun 19, 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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