Cognitive Training and Dual-task Ability

April 5, 2017 updated by: VA Office of Research and Development

Cognitive Training and Dual-task Ability in Older Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical and Rehab Center, Decatur, GA
    • Tennessee
      • Mountain Home, Tennessee, United States, 37684
        • Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balance rehabilitation + dual-tasking
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.
Behavioral: Balance rehabilitation + dual-tasking
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
Active Comparator: Standard balance rehabilitation
Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Behavioral: Standard balance rehabilitation
Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Experimental: Cognitive training (speed of processing)
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.
Behavioral: Cognitive training (speed of processing)
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.
Active Comparator: Cognitive training (general cognition)
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.
Behavioral: Cognitive training (general cognition)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 weeks
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.
baseline and 6 weeks
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.
baseline and 6 weeks
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.
baseline and 6 weeks
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.
baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7614-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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