Gait Disorder
Conditions
Keywords
aged or aged 80 and over, gait disorder, attention
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.
Interventions
BEHAVIORALBalance 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
BEHAVIORALStandard 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.
BEHAVIORALCognitive 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.
BEHAVIORALCognitive 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Scores in Timed up and go With Cognitive Task | 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
| Measure | Time frame | Description |
|---|---|---|
| Change Scores in Walk While Talk Test With Verbal Fluency Task | baseline and 6 weeks | The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task. |
| Change Scores in Dynamic Gait Index | 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. |
| Change Scores in Sensory Organization Test (SOT) | 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. |
| Change Scores in Preferred Gait Speed | baseline and 6 weeks | Subjects walk at their preferred speed and time to walk 6 m is recorded. |
| Change Scores in Activities-specific Balance-related Confidence | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 can safely perform the primary balance or gait task.
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 | 10 |
| 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.
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. | 7 |
| 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 (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. | 11 |
| 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.
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. | 6 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | change in health status | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Balance Rehabilitation + Dual-task Practice | Standard Balance Rehabilitation | Cognitive Training (Speed of Processing) | Cognitive Training (General Cognition) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 77.0 years STANDARD_DEVIATION 8.3 | 81.9 years STANDARD_DEVIATION 7.9 | 78.1 years STANDARD_DEVIATION 6.7 | 80.7 years STANDARD_DEVIATION 11.1 | 79.0 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 7 Participants | 11 Participants | 6 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 9 Participants | 5 Participants | 28 Participants |
| Region of Enrollment United States | 10 participants | 7 participants | 11 participants | 6 participants | 34 participants |
| Sex: Female, Male Female | 8 Participants | 0 Participants | 5 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 6 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 1 / 6 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 8 | 0 / 6 |
Outcome results
Primary
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.
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balance Rehabilitation + Dual-task Practice | Change Scores in Timed up and go With Cognitive Task | -0.89 seconds | Standard Deviation 3.36 |
| Standard Balance Rehabilitation | Change Scores in Timed up and go With Cognitive Task | -0.37 seconds | Standard Deviation 2.24 |
| Cognitive Training (Speed of Processing) | Change Scores in Timed up and go With Cognitive Task | -0.64 seconds | Standard Deviation 1.62 |
| Cognitive Training (General Cognition) | Change Scores in Timed up and go With Cognitive Task | -1.42 seconds | Standard Deviation 1.92 |
Comparison: Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.p-value: 0.562Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.p-value: 0.414Wilcoxon (Mann-Whitney)
Secondary
Change Scores in 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. 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.
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balance Rehabilitation + Dual-task Practice | Change Scores in Activities-specific Balance-related Confidence | 10.70 overall percentage of confidence | Standard Deviation 14.44 |
| Standard Balance Rehabilitation | Change Scores in Activities-specific Balance-related Confidence | 3.16 overall percentage of confidence | Standard Deviation 7.04 |
| Cognitive Training (Speed of Processing) | Change Scores in Activities-specific Balance-related Confidence | -0.31 overall percentage of confidence | Standard Deviation 7.88 |
| Cognitive Training (General Cognition) | Change Scores in Activities-specific Balance-related Confidence | -8.59 overall percentage of confidence | Standard Deviation 13.62 |
Comparison: Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.p-value: 0.263Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.p-value: 0.181Wilcoxon (Mann-Whitney)
Secondary
Change Scores in Dynamic Gait Index
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.
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balance Rehabilitation + Dual-task Practice | Change Scores in Dynamic Gait Index | 2.50 units on a scale | Standard Deviation 2.07 |
| Standard Balance Rehabilitation | Change Scores in Dynamic Gait Index | 1.50 units on a scale | Standard Deviation 4.64 |
| Cognitive Training (Speed of Processing) | Change Scores in Dynamic Gait Index | -0.38 units on a scale | Standard Deviation 1.92 |
| Cognitive Training (General Cognition) | Change Scores in Dynamic Gait Index | 0.00 units on a scale | Standard Deviation 2.45 |
Comparison: Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.p-value: 0.662Wilcoxon (Mann-Whitney)
Secondary
Change Scores in Preferred Gait Speed
Subjects walk at their preferred speed and time to walk 6 m is recorded.
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balance Rehabilitation + Dual-task Practice | Change Scores in Preferred Gait Speed | 0.07 meters per second | Standard Deviation 0.29 |
| Standard Balance Rehabilitation | Change Scores in Preferred Gait Speed | 0.24 meters per second | Standard Deviation 0.4 |
| Cognitive Training (Speed of Processing) | Change Scores in Preferred Gait Speed | 0.05 meters per second | Standard Deviation 0.51 |
| Cognitive Training (General Cognition) | Change Scores in Preferred Gait Speed | 0.16 meters per second | Standard Deviation 0.18 |
Comparison: Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.p-value: 0.313Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.p-value: 0.852Wilcoxon (Mann-Whitney)
Secondary
Change Scores in 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. 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.
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balance Rehabilitation + Dual-task Practice | Change Scores in Sensory Organization Test (SOT) | 6.44 units on a scale | Standard Deviation 12.03 |
| Standard Balance Rehabilitation | Change Scores in Sensory Organization Test (SOT) | -1.50 units on a scale | Standard Deviation 5.65 |
| Cognitive Training (Speed of Processing) | Change Scores in Sensory Organization Test (SOT) | -0.50 units on a scale | Standard Deviation 20.28 |
| Cognitive Training (General Cognition) | Change Scores in Sensory Organization Test (SOT) | 8.60 units on a scale | Standard Deviation 6.19 |
Comparison: Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.p-value: 0.05Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.p-value: 0.171Wilcoxon (Mann-Whitney)
Secondary
Change Scores in Walk While Talk Test With Verbal Fluency Task
The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balance Rehabilitation + Dual-task Practice | Change Scores in Walk While Talk Test With Verbal Fluency Task | 1.76 seconds | Standard Deviation 3.48 |
| Standard Balance Rehabilitation | Change Scores in Walk While Talk Test With Verbal Fluency Task | -3.83 seconds | Standard Deviation 9.66 |
| Cognitive Training (Speed of Processing) | Change Scores in Walk While Talk Test With Verbal Fluency Task | -2.73 seconds | Standard Deviation 4.67 |
| Cognitive Training (General Cognition) | Change Scores in Walk While Talk Test With Verbal Fluency Task | 3.01 seconds | Standard Deviation 10.04 |
Comparison: Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.p-value: 0.181Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.p-value: 1Wilcoxon (Mann-Whitney)