Motor Activity
Conditions
Brief summary
The investigators propose a single-blind randomized clinical trial to determine if seniors show improved mobility (walking speed) and cognition following motor imagery (imagined walking) training. They hypothesize that imagined walking can be used as a rehabilitative tool for improving walking speed and cognition in the elderly, because it engages and strengthens similar neural systems as actual walking and cognition.
Detailed description
The proposed research aims to establish the efficacy of an imagined gait protocol for improving gait and cognition in the elderly. This imagined gait protocol involves imagined gait in single (imagined walking; iW) and dual-task (imagined walking while talking; iWWT) situations. A single-blind randomized clinical trial of 58 cognitively-healthy elderly with pre-post measures of gait, cognition, and functional Magnetic Resonance Imaging (fMRI) during imagined gait is proposed. The overall hypothesis is that imagined gait can be used as a rehabilitative tool for improving gait and cognition in the elderly because it engages and strengthens similar neural systems as actual gait and cognition. The first aim of this study is to establish the efficacy of our imagined gait protocol to improve gait and cognition in the elderly. We predict that our imagined gait intervention will improve gait velocity during actual walking and walking-while-talking conditions to a greater extent than the active control (visual imagery) intervention. We also predict that our imagined gait intervention will cognitive performance during dual-task walking conditions. The second aim of this study is to determine neuroplasticity changes in response to our imagined gait protocol. We predict that the neural systems engaged during imagined gait will change following our imagined gait intervention.
Interventions
BEHAVIORALImagined Gait Intervention
Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
BEHAVIORALVisual Imagery Intervention
Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Sponsors
National Institute on Aging (NIA)
National Center for Advancing Translational Sciences (NCATS)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults between 65 and 85 years and older, residing in the community. * Able to speak English at a level sufficient to undergo study procedures. * Plan to be in the area for the next 3 months.
Exclusion criteria
* Presence of dementia (telephone-based memory impairment screen \< 5 or Ascertain Dementia 8-item Informant Questionnaire score \> 1) * Presence of gait disorder diagnosed by clinician (e.g. neuropathy). * Any medical condition or chronic medication use (e.g. neuroleptics) that will compromise safety or affect cognitive functioning. * Terminal illness with life expectancy \<12 months. * Progressive, degenerative neurologic disease (e.g. Parkinson's disease, ALS). * Major psychiatric disorders such as Schizophrenia. * Pacemaker or any permanent metal implants like hip prosthesis (other than tooth fillings) and claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed During Single and Dual-task Walking Conditions | Baseline and 3 months | Change in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway. A positive mean value is indicative of an improvement (increase) in gait speed post-intervention, whereas a negative mean value is indicative of a decrease in gait speed post-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions | Baseline and 3 months | Change in blood-oxygen-level-dependent (BOLD) signal (neuroplasticity) during imagined walking and walking while talking (iWWT) conditions were measured using functional magnetic resonance imaging (fMRI). The mean values reported are changes in factor scores that reflect the overall change in BOLD signal pre- to post-intervention. Positive values reflect an increase in BOLD signal post-intervention, whereas, negative mean values reflect a decrease in BOLD signal post intervention. There are no minimum or maximum values or ranges or thresholds associated with the BOLD measure. |
| Change in Trail Making Test Form A | Baseline and 3 months | Change in Trail Making Test Form A (TMT-A), is a timed measurement of attention and processing speed. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter time indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-A uses all numbers (no letters) and includes correction of errors prompted by the examiner. |
| Change in Trail Making Test Form B | Baseline and 3 months | Change in Trail Making Test, Form B (TMT-B), is a timed measurement of attention, processing speed, and set-shifting. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter times indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-B alternates between numbers and letters requiring the participant to switch between numbers and letters in consecutive order and includes correction of errors prompted by the examiner. |
| Change in Trail Making Test Form B Minus Form A | Baseline and 3 months | Change in Trail Making Test Form B (TMT-B) minus Form A (TMT-A), a timed measure of set-shifting. Scoring is based on the change in time between completing Form B compared to Form A. A negative mean difference reflects an improvement post intervention. |
| Change in Letter Number Sequencing Task Score | Baseline and 3 months | Change in scoring in the letter number sequencing task, a measure of item manipulation, was derived from the letter number sequencing subtest of the working memory domain within the Wechsler Adult Intelligence Scale (WAIS) III battery, a widely used intelligence test for adults. Scoring is based on the number of correctly sequenced letters and numbers with increasing (positive) mean scores indicating an improvement in task performance post intervention. A negative mean score reflects a decrease in task performance post intervention. |
| Change in Cognitive Performance During Walking While Talking | Baseline and 3 months | Change in cognitive performance was assessed by the number of correct letters/time (in seconds) generated during walking while talking (WWT). This exercise consists of having the participant walk around a computerized walkway while reciting alternate letters of the alphabet (WWT), starting with the letter B. A positive mean value reflects an improvement in cognitive performance (increase in the number of correct letters/time generated) post-intervention; whereas, a negative mean value reflects worsening in cognitive performance (decrease in the number of correct letters/time generated) post-intervention. |
| Change in Flanker Interference Task | Baseline and 3 months | Change in the Flanker Interference Task measures how much interference is generated by the presentation of adjacent incongruent and congruent visual information. Scoring is based on the difference in reaction time (in milliseconds) between incongruent and congruent trials responded to correctly. A negative mean is indicative of improved interference post intervention and a positive mean value is indicative of worsening interference post intervention. |
| Change in Stride Length | Baseline and 3 months | Change in stride length were collected during walking while talking (WWT) conditions on an instrumented walkway. Stride length was defined as the distance between the heel points of 2 consecutive footfalls of the same foot and measured in centimeters (cm). |
| Change in Gait Variability | Baseline and 3 months | Change in gait variability is collected during walking while talking on an instrumented walkway. Gait variability, defined as the stride-to-stride fluctuations in walking, was measured by the coefficient of variation (CV) of the mean value of stride-to stride time. CV reflects the level of gait rhythmicity, with lower values indicating greater rhythmicity. A negative mean CV reflects improved (less) variability post intervention whereas a positive mean CV value reflects worse (increased) variability. Stride time CV is closely associated with falls |
| Change in Gait Domains | Baseline and 3 months | Change in gait domains (summary measures reported in standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal pace walking and walking while talking. Gait domain score is calculated by summing ratings for individual items and dividing by the maximum possible score for the domain, then multiplying by 100. The domain score ranges from 0 to 100, with higher scores reflecting more gait disturbance and lower scores reflecting less gait disturbance. |
| Change in Stroop Interference Test: Color-Word Minus Color Score | Baseline and 3 months | Change in Stroop Interference Test: Color-Word (incongruent trials) minus Color (congruent trials) scores were determined. It is a measure of response competition and interference. Scoring is based on the time it takes to read (complete) incongruent trials relative to congruent trials. A negative mean value reflects an improvement in performance after the intervention. A positive mean value reflects an decrease in performance after the intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in White Matter Integrity | Baseline and 3 months | Change in White Matter Integrity obtained from diffusion-weighted imaging. Increased white matter integrity is associated with improved cognitive performance whereas decreased white matter integrity is associated with decreased cognitive performance. |
| Change in Free Cued Serial Recall Test | Baseline and 3 months | Changes in free recall performance were based on the free cued serial recall test, a measure of verbal learning and memory. Scores range from 0 to 48. Mean values reflect the change in the number of items recalled pre and post intervention. A positive mean value indicates improved recall performance post intervention whereas a negative mean value reflects decreased performance post intervention. |
| Change in White Matter Hyperintensities | Baseline and 3 months | Change in White Matter Hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes. |
| Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Baseline and 3 months | Change in delayed figure copy recall performance from the RBANS assessment, a measure of spatial learning and memory. Figure copy recall scores range from 0 to 20. A positive mean is indicative of an increase in recall post intervention whereas a negative mean is indicative of a decrease in recall post intervention. |
| Change in Controlled Oral Word Fluency Test | Baseline and 3 months | Change in the number of correct words generated on the controlled oral word fluency test, a measure of language processing. Scores range from 0 to 36. A positive mean reflects an improvement in language processing post intervention whereas a negative mean reflects worsening of language processing post intervention |
| Change in Semantic Fluency Test | Baseline and 3 months | Change in the total number of correct words generated for each category on the semantic fluency test, a measure of language processing. Scores reflect the number of correct items generated in a 60 second window. A positive mean value reflects improved semantic fluency post intervention and a negative mean value reflects worsening of semantic fluency post intervention. |
| Change in Digit Symbol Substitution | Baseline and 3 months | Change in number of correct digit symbols generated on the digit symbol substitution test (DSST), a measure of processing speed, attention and working memory. The number of correct symbols within the allowed time in seconds is measured. A positive mean reflects an improvement in the number of correct digit symbols generated post intervention whereas a negative mean value reflects fewer correct digits generated post intervention. |
| Modified Short Physical Performance Battery (SPPB) at Baseline | Baseline | SPPB is a measure of lower extremity function and includes a balance test, a chair stand test and a gait speed test. Because gait speed/velocity was our primary outcome, only administered the balance and chair stand tests were administered. Thus, possible scores range from 0-8 (rather than the typical 0-12) with 0 being worst performance and 8 being best performance. |
| Change in Immediate Maze Task Performance | Baseline and 3 months | Change in mean immediate maze performance (time in seconds), a measure of spatial navigation and memory, were determined. A negative mean value represents an improvement in immediate maze performance post intervention whereas a positive mean value represents worsening of maze performance post intervention. |
| Change in Delayed Maze Task Performance | Baseline and 3 months | Change in mean delayed maze performance (time in seconds), a measurement of spatial navigation and memory, were determined. A negative mean value represents an improvement in delayed maze performance post intervention, whereas a positive mean performance time represents worsening delayed maze performance post intervention |
| Change in Errors on Maze Task | Baseline and 3 months | The number of errors during maze performance, a measure of spatial navigation and memory, will be assessed. A negative mean result is indicative of an improvement (fewer errors) post intervention whereas a positive mean result is indicative of a reduction in performance (more errors) post intervention. |
| Change in Geriatric Depression Scale | Baseline and 3 months | The Geriatric Depression Scale (GDS) will be used to to determine mean changes in depressive symptoms from baseline. Scores range from 0 to 30. Scores of 0 - 9 are considered normal, 10 - 19 indicate mild depression and 20 30 indicate severe depression. As such, higher scores are indicative of more severe depressive symptoms. A positive mean value reflects an increase in depressive symptoms post-intervention whereas a negative value reflects a decrease in depressive symptoms post intervention. |
| Change in Beck Anxiety Inventory | Baseline and 3 months | Change in symptoms of anxiety. Scores range from 0 to 84 with higher values reflecting more anxiety symptoms. A negative mean reflects a reduction in anxiety symptoms post intervention and a positive mean value reflects an increase in anxiety symptoms post intervention |
| Change in Gray Matter Cortical Thickness | Baseline and 3 months | Change in mean Cortical Thickness obtained from T1-weighted structural images. A positive mean value reflects an increase in cortical thickness post intervention and a negative mean value reflects a decrease in cortical thickness post intervention |
Countries
United States
Participant flow
Pre-assignment details
Randomization goal was 48 but two extra randomization slots were added as a buffer. Once 24 in each condition had been randomized, recruitment stopped, resulting in a total of 49 randomized participants.
Participants by arm
| Arm | Count |
|---|---|
| Imagined Gait Intervention During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. | 25 |
| Visual Imagery Intervention During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 7 |
| Overall Study | Study Suspension due to COVID pandemic | 1 | 3 |
Baseline characteristics
| Characteristic | Imagined Gait Intervention | Total | Visual Imagery Intervention |
|---|---|---|---|
| Age, Continuous | 72.92 years STANDARD_DEVIATION 5.28 | 72.86 years STANDARD_DEVIATION 5.02 | 72.79 years STANDARD_DEVIATION 4.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 39 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 22 Participants | 12 Participants |
| Region of Enrollment United States | 25 participants | 49 participants | 24 participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 17 Participants | 32 Participants | 15 Participants |
| Years of Education | 15.60 years STANDARD_DEVIATION 3.06 | 16.04 years STANDARD_DEVIATION 3.01 | 16.52 years STANDARD_DEVIATION 2.95 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 5 / 25 | 11 / 24 |
| serious Total, serious adverse events | 0 / 25 | 1 / 24 |
Outcome results
Primary
Change in Walking Speed During Single and Dual-task Walking Conditions
Change in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway. A positive mean value is indicative of an improvement (increase) in gait speed post-intervention, whereas a negative mean value is indicative of a decrease in gait speed post-intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagined Gait Intervention | Change in Walking Speed During Single and Dual-task Walking Conditions | Gait speed (normal pace) | -3.33 centimeters per second | Standard Deviation 14.13 |
| Imagined Gait Intervention | Change in Walking Speed During Single and Dual-task Walking Conditions | Gait speed (walking-while-talking) | 5.89 centimeters per second | Standard Deviation 20.44 |
| Visual Imagery Intervention | Change in Walking Speed During Single and Dual-task Walking Conditions | Gait speed (normal pace) | -0.53 centimeters per second | Standard Deviation 25.77 |
| Visual Imagery Intervention | Change in Walking Speed During Single and Dual-task Walking Conditions | Gait speed (walking-while-talking) | -10.55 centimeters per second | Standard Deviation 15.68 |
Comparison: A linear mixed effects model was used to compare changes in normal pace gait speed pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-19.36, 15.12]
Comparison: A linear mixed effects model was used to compare changes in gait speed during walking while talking pre and post intervention95% CI: [1.4, 32.97]
Secondary
Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions
Change in blood-oxygen-level-dependent (BOLD) signal (neuroplasticity) during imagined walking and walking while talking (iWWT) conditions were measured using functional magnetic resonance imaging (fMRI). The mean values reported are changes in factor scores that reflect the overall change in BOLD signal pre- to post-intervention. Positive values reflect an increase in BOLD signal post-intervention, whereas, negative mean values reflect a decrease in BOLD signal post intervention. There are no minimum or maximum values or ranges or thresholds associated with the BOLD measure.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the Visual Imagery group and 2 participants in the Imagined Gait group due to incomplete tasks/sessions or corrupted data files.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions | -2.98 Factor score for BOLD signal | Standard Deviation 19.35 |
| Visual Imagery Intervention | Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions | -3.07 Factor score for BOLD signal | Standard Deviation 11.89 |
Comparison: Linear mixed effects model were used to compare changes in the functional activation/deactivation pattern (factor score) during imagery of walking-while talking (relative to walking and talking alone) pre and post intervention - as a function of of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-12.04, 16.85]
Secondary
Change in Cognitive Performance During Walking While Talking
Change in cognitive performance was assessed by the number of correct letters/time (in seconds) generated during walking while talking (WWT). This exercise consists of having the participant walk around a computerized walkway while reciting alternate letters of the alphabet (WWT), starting with the letter B. A positive mean value reflects an improvement in cognitive performance (increase in the number of correct letters/time generated) post-intervention; whereas, a negative mean value reflects worsening in cognitive performance (decrease in the number of correct letters/time generated) post-intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the Visual Imagery group and 7 participants in the Imagined Gait group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Cognitive Performance During Walking While Talking | 0.19 correct letters/second | Standard Deviation 1.46 |
| Visual Imagery Intervention | Change in Cognitive Performance During Walking While Talking | -1.54 correct letters/second | Standard Deviation 1.5 |
Comparison: A linear mixed effects model was used to compare changes in correct letters generated pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [0.21, 2.99]
Secondary
Change in Flanker Interference Task
Change in the Flanker Interference Task measures how much interference is generated by the presentation of adjacent incongruent and congruent visual information. Scoring is based on the difference in reaction time (in milliseconds) between incongruent and congruent trials responded to correctly. A negative mean is indicative of improved interference post intervention and a positive mean value is indicative of worsening interference post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 7 participants in the Visual Imagery Group and 13 participants in the Imagined Gait group due to incomplete tasks/sessions or corrupted data files.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Flanker Interference Task | -49.55 milliseconds | Standard Deviation 108.85 |
| Visual Imagery Intervention | Change in Flanker Interference Task | -94.69 milliseconds | Standard Deviation 93.97 |
Comparison: A linear mixed effects model was used to compare changes in flanker interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-149.94, 163.47]
Secondary
Change in Gait Domains
Change in gait domains (summary measures reported in standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal pace walking and walking while talking. Gait domain score is calculated by summing ratings for individual items and dividing by the maximum possible score for the domain, then multiplying by 100. The domain score ranges from 0 to 100, with higher scores reflecting more gait disturbance and lower scores reflecting less gait disturbance.
Time frame: Baseline and 3 months
Population: Data were unable to be accurately computed for Gait Domain outcome measure due to incomplete data collection of the individual gait variable measurements which would have been summed to generate a Gait Domain Score. Since there was not enough data overall for the models to converge Gait Domain data was not able to be collected.
Secondary
Change in Gait Variability
Change in gait variability is collected during walking while talking on an instrumented walkway. Gait variability, defined as the stride-to-stride fluctuations in walking, was measured by the coefficient of variation (CV) of the mean value of stride-to stride time. CV reflects the level of gait rhythmicity, with lower values indicating greater rhythmicity. A negative mean CV reflects improved (less) variability post intervention whereas a positive mean CV value reflects worse (increased) variability. Stride time CV is closely associated with falls
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Visual Imagery group and 6 participants in the Imagined Gait group due to missing data or corrupted data files.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Gait Variability | -0.17 Coefficient of Variation (CV) | Standard Deviation 2.45 |
| Visual Imagery Intervention | Change in Gait Variability | 1.81 Coefficient of Variation (CV) | Standard Deviation 1.56 |
Comparison: A linear mixed effects model was used to compare changes in gait variability during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-3.73, -0.2]
Secondary
Change in Letter Number Sequencing Task Score
Change in scoring in the letter number sequencing task, a measure of item manipulation, was derived from the letter number sequencing subtest of the working memory domain within the Wechsler Adult Intelligence Scale (WAIS) III battery, a widely used intelligence test for adults. Scoring is based on the number of correctly sequenced letters and numbers with increasing (positive) mean scores indicating an improvement in task performance post intervention. A negative mean score reflects a decrease in task performance post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Letter Number Sequencing Task Score | -0.55 Correct sequences | Standard Deviation 2.15 |
| Visual Imagery Intervention | Change in Letter Number Sequencing Task Score | 0.61 Correct sequences | Standard Deviation 1.84 |
Comparison: A linear mixed effects model was used to compare changes in correct letter number sequences pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-2.65, 0.79]
Secondary
Change in Stride Length
Change in stride length were collected during walking while talking (WWT) conditions on an instrumented walkway. Stride length was defined as the distance between the heel points of 2 consecutive footfalls of the same foot and measured in centimeters (cm).
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Visual Imagery group and 6 participants in the Imagined Gait group due to missing data or corrupted data files.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Stride Length | 3.08 centimeters | Standard Deviation 9.33 |
| Visual Imagery Intervention | Change in Stride Length | -11.49 centimeters | Standard Deviation 13.37 |
Comparison: A linear mixed effects model was used to compare changes in stride length during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [5.99, 24.41]
Secondary
Change in Stroop Interference Test: Color-Word Minus Color Score
Change in Stroop Interference Test: Color-Word (incongruent trials) minus Color (congruent trials) scores were determined. It is a measure of response competition and interference. Scoring is based on the time it takes to read (complete) incongruent trials relative to congruent trials. A negative mean value reflects an improvement in performance after the intervention. A positive mean value reflects an decrease in performance after the intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure) and for 1 participant in the Imagined Gait group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Stroop Interference Test: Color-Word Minus Color Score | -8.38 seconds | Standard Deviation 30.14 |
| Visual Imagery Intervention | Change in Stroop Interference Test: Color-Word Minus Color Score | -14.47 seconds | Standard Deviation 31.37 |
Comparison: A linear mixed effects model was used to compare changes in Stroop interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-24, 26.78]
Secondary
Change in Trail Making Test Form A
Change in Trail Making Test Form A (TMT-A), is a timed measurement of attention and processing speed. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter time indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-A uses all numbers (no letters) and includes correction of errors prompted by the examiner.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Trail Making Test Form A | -0.72 seconds | Standard Deviation 19.16 |
| Visual Imagery Intervention | Change in Trail Making Test Form A | -1.45 seconds | Standard Deviation 5.93 |
Comparison: Linear mixed effects model were used to compare changes in trails a time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-14.15, 13.07]
Secondary
Change in Trail Making Test Form B
Change in Trail Making Test, Form B (TMT-B), is a timed measurement of attention, processing speed, and set-shifting. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter times indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-B alternates between numbers and letters requiring the participant to switch between numbers and letters in consecutive order and includes correction of errors prompted by the examiner.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Trail Making Test Form B | 4.49 seconds | Standard Deviation 54.18 |
| Visual Imagery Intervention | Change in Trail Making Test Form B | -9.54 seconds | Standard Deviation 19.74 |
Comparison: Linear mixed effects model were used to compare changes in trails b time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-51.92, 27.51]
Secondary
Change in Trail Making Test Form B Minus Form A
Change in Trail Making Test Form B (TMT-B) minus Form A (TMT-A), a timed measure of set-shifting. Scoring is based on the change in time between completing Form B compared to Form A. A negative mean difference reflects an improvement post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Trail Making Test Form B Minus Form A | 5.22 seconds | Standard Deviation 50.28 |
| Visual Imagery Intervention | Change in Trail Making Test Form B Minus Form A | -8.09 seconds | Standard Deviation 23.09 |
Comparison: Linear mixed effects model were used to compare changes in trails B minus A time pre and post intervention.95% CI: [-48.12, 26.47]
Other Pre-specified
Change in Beck Anxiety Inventory
Change in symptoms of anxiety. Scores range from 0 to 84 with higher values reflecting more anxiety symptoms. A negative mean reflects a reduction in anxiety symptoms post intervention and a positive mean value reflects an increase in anxiety symptoms post intervention
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 6 participants in the in the Imagined Gait group and 2 participants in the in the Visual Imagery group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Beck Anxiety Inventory | 0.24 score on a scale | Standard Deviation 1.92 |
| Visual Imagery Intervention | Change in Beck Anxiety Inventory | 1.00 score on a scale | Standard Deviation 4.16 |
Comparison: A linear mixed effects model was used to compare changes in anxiety symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-3.38, 1.49]
Other Pre-specified
Change in Controlled Oral Word Fluency Test
Change in the number of correct words generated on the controlled oral word fluency test, a measure of language processing. Scores range from 0 to 36. A positive mean reflects an improvement in language processing post intervention whereas a negative mean reflects worsening of language processing post intervention
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Controlled Oral Word Fluency Test | 0.32 correct items generated | Standard Deviation 18.37 |
| Visual Imagery Intervention | Change in Controlled Oral Word Fluency Test | 2.90 correct items generated | Standard Deviation 11.72 |
Comparison: A linear mixed effects model was used to compare changes in word fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-20.01, 7.28]
Other Pre-specified
Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Change in delayed figure copy recall performance from the RBANS assessment, a measure of spatial learning and memory. Figure copy recall scores range from 0 to 20. A positive mean is indicative of an increase in recall post intervention whereas a negative mean is indicative of a decrease in recall post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 0.84 correct items recalled | Standard Deviation 5.83 |
| Visual Imagery Intervention | Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 2.47 correct items recalled | Standard Deviation 5.48 |
Comparison: A linear mixed effects model was used to compare changes in delayed figure copy recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-5.88, 2]
Other Pre-specified
Change in Delayed Maze Task Performance
Change in mean delayed maze performance (time in seconds), a measurement of spatial navigation and memory, were determined. A negative mean value represents an improvement in delayed maze performance post intervention, whereas a positive mean performance time represents worsening delayed maze performance post intervention
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 4 participants in the in the Imagined Gait group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Delayed Maze Task Performance | 7.25 seconds | Standard Deviation 42.07 |
| Visual Imagery Intervention | Change in Delayed Maze Task Performance | 4.04 seconds | Standard Deviation 5.23 |
Comparison: A linear mixed effects model was used to compare changes in delayed maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-20.65, 27.18]
Other Pre-specified
Change in Digit Symbol Substitution
Change in number of correct digit symbols generated on the digit symbol substitution test (DSST), a measure of processing speed, attention and working memory. The number of correct symbols within the allowed time in seconds is measured. A positive mean reflects an improvement in the number of correct digit symbols generated post intervention whereas a negative mean value reflects fewer correct digits generated post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Please note that data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Imagined Gait group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Digit Symbol Substitution | 0.11 correct digit symbols | Standard Deviation 20.1 |
| Visual Imagery Intervention | Change in Digit Symbol Substitution | -2.61 correct digit symbols | Standard Deviation 22.26 |
Comparison: A linear mixed effects model was used to compare changes in digit symbol substitution performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-16.1, 16.03]
Other Pre-specified
Change in Errors on Maze Task
The number of errors during maze performance, a measure of spatial navigation and memory, will be assessed. A negative mean result is indicative of an improvement (fewer errors) post intervention whereas a positive mean result is indicative of a reduction in performance (more errors) post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 5 participants in the in the Imagined Gait group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Errors on Maze Task | -0.27 errors | Standard Deviation 1.03 |
| Visual Imagery Intervention | Change in Errors on Maze Task | 0.14 errors | Standard Deviation 0.32 |
Comparison: A linear mixed effects model was used to compare changes in maze errors pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-0.45, 0.9]
Other Pre-specified
Change in Free Cued Serial Recall Test
Changes in free recall performance were based on the free cued serial recall test, a measure of verbal learning and memory. Scores range from 0 to 48. Mean values reflect the change in the number of items recalled pre and post intervention. A positive mean value indicates improved recall performance post intervention whereas a negative mean value reflects decreased performance post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Free Cued Serial Recall Test | 1.14 correct items recalled | Standard Deviation 13.01 |
| Visual Imagery Intervention | Change in Free Cued Serial Recall Test | -1.02 correct items recalled | Standard Deviation 5.81 |
Comparison: A linear mixed effects model was used to compare changes in total free recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-5.98, 10.84]
Other Pre-specified
Change in Geriatric Depression Scale
The Geriatric Depression Scale (GDS) will be used to to determine mean changes in depressive symptoms from baseline. Scores range from 0 to 30. Scores of 0 - 9 are considered normal, 10 - 19 indicate mild depression and 20 30 indicate severe depression. As such, higher scores are indicative of more severe depressive symptoms. A positive mean value reflects an increase in depressive symptoms post-intervention whereas a negative value reflects a decrease in depressive symptoms post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 3 participants in the in the Imagined Gait group and 2 participants in the in the Visual Imagery group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Geriatric Depression Scale | 0.11 score on a scale | Standard Deviation 2.3 |
| Visual Imagery Intervention | Change in Geriatric Depression Scale | 0.00 score on a scale | Standard Deviation 2.39 |
Comparison: A linear mixed effects model was used to compare changes in depressive symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-1.74, 2.26]
Other Pre-specified
Change in Gray Matter Cortical Thickness
Change in mean Cortical Thickness obtained from T1-weighted structural images. A positive mean value reflects an increase in cortical thickness post intervention and a negative mean value reflects a decrease in cortical thickness post intervention
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the in the Visual Imagery group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Gray Matter Cortical Thickness | -0.03 millimeters | Standard Deviation 0.09 |
| Visual Imagery Intervention | Change in Gray Matter Cortical Thickness | -0.07 millimeters | Standard Deviation 0.03 |
Comparison: A linear mixed effects model was used to compare changes in cortical thickness pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-0.04, 0.12]
Other Pre-specified
Change in Immediate Maze Task Performance
Change in mean immediate maze performance (time in seconds), a measure of spatial navigation and memory, were determined. A negative mean value represents an improvement in immediate maze performance post intervention whereas a positive mean value represents worsening of maze performance post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 5 participants in the in the Imagined Gait group due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Immediate Maze Task Performance | 9.27 seconds | Standard Deviation 23.21 |
| Visual Imagery Intervention | Change in Immediate Maze Task Performance | 4.09 seconds | Standard Deviation 6.48 |
Comparison: A linear mixed effects model was used to compare changes in immediate maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-11.14, 18.42]
Other Pre-specified
Change in Semantic Fluency Test
Change in the total number of correct words generated for each category on the semantic fluency test, a measure of language processing. Scores reflect the number of correct items generated in a 60 second window. A positive mean value reflects improved semantic fluency post intervention and a negative mean value reflects worsening of semantic fluency post intervention.
Time frame: Baseline and 3 months
Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Change in Semantic Fluency Test | 3.53 correct words/minute | Standard Deviation 17.04 |
| Visual Imagery Intervention | Change in Semantic Fluency Test | -4.20 correct words/minute | Standard Deviation 14.18 |
Comparison: A linear mixed effects model was used to compare changes in semantic fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)95% CI: [-6.51, 17.97]
Other Pre-specified
Change in White Matter Hyperintensities
Change in White Matter Hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes.
Time frame: Baseline and 3 months
Population: Results were unable to be computed for White Matter Hyperintensities due to limited data.
Other Pre-specified
Change in White Matter Integrity
Change in White Matter Integrity obtained from diffusion-weighted imaging. Increased white matter integrity is associated with improved cognitive performance whereas decreased white matter integrity is associated with decreased cognitive performance.
Time frame: Baseline and 3 months
Population: Results were unable to be computed for White Matter Integrity due to limited data.
Other Pre-specified
Modified Short Physical Performance Battery (SPPB) at Baseline
SPPB is a measure of lower extremity function and includes a balance test, a chair stand test and a gait speed test. Because gait speed/velocity was our primary outcome, only administered the balance and chair stand tests were administered. Thus, possible scores range from 0-8 (rather than the typical 0-12) with 0 being worst performance and 8 being best performance.
Time frame: Baseline
Population: SPPB was only administered at baseline (only the balance and chair tests were administered). Change analyses were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Imagined Gait Intervention | Modified Short Physical Performance Battery (SPPB) at Baseline | 6.79 score on a scale | Standard Deviation 1.17 |
| Visual Imagery Intervention | Modified Short Physical Performance Battery (SPPB) at Baseline | 6.30 score on a scale | Standard Deviation 1.34 |