Cognitive Training and Dual-task Ability in Older Adults

Gait Disorder Clinical Trial

— Cog training  

Official title:

Cognitive Training and Dual-task Ability in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895608
• Other study ID #: E7614-P
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: January 26, 2016
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gait Disorder

Intervention

Other:
• Balance rehabilitation + dual-task practice
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
Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.

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.
• 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.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia
United States	Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN	Mountain Home	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and go with secondary tasks	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 will be recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability.	12 weeks	No
Secondary	Walk while talk test	The walk while talk (WWT) test involves walking at preferred speed under the following conditions: no cognitive task (WWT), a simple cognitive task (reciting the alphabet; WWT-s) and a complex cognitive task (reciting every other letter of the alphabet; WWT-c).1 A verbal fluency task (WWT-v) and counting backwards by 3s (WWT-count) will be included.	12 weeks	No
Secondary	Dynamic gait index	Dynamic Gait Index assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability.	12 weeks	No
Secondary	Sensory organization test (SOT)	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.	12 weeks	No
Secondary	Preferred gait speed	Subjects walk at their preferred speed and time to walk 6 m is recorded.	12 weeks	No
Secondary	Activities-specific balance-related confidence	Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability.	12 weeks	No