NCT01895608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 19, 2017

Completed
Last Updated

June 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

June 19, 2013

Results QC Date

January 27, 2017

Last Update Submit

April 5, 2017

Conditions

Keywords

aged or aged 80 and overgait disorderattention

Outcome Measures

Primary Outcomes (1)

  • Change Scores in Timed up and go With Cognitive Task

    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 Outcomes (5)

  • 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

  • Change Scores in Sensory Organization Test (SOT)

    baseline and 6 weeks

  • Change Scores in Preferred Gait Speed

    baseline and 6 weeks

  • Change Scores in Activities-specific Balance-related Confidence

    baseline and 6 weeks

Study Arms (4)

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.

Behavioral: Balance rehabilitation + dual-tasking

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.

Behavioral: Standard balance rehabilitation

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.

Behavioral: Cognitive training (speed of processing)

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.

Behavioral: Cognitive training (general cognition)

Interventions

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

Balance rehabilitation + dual-tasking

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

Standard balance rehabilitation

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 (speed of processing)

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.

Cognitive training (general cognition)

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Mountain Home, Tennessee, 37684, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Courtney Hall
Organization
James H Quillen VAMC

Study Officials

  • Courtney D Hall, PhD PT

    Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2013

First Posted

July 10, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 19, 2017

Results First Posted

June 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations