Motor Imagery Intervention for Improving Gait and Cognition in the Elderly

Motor Activity Clinical Trial

Official title:

Motor Imagery Intervention for Improving Gait and Cognition in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762604
• Other study ID #: 2014-3633
• Secondary ID: K01AG049829KL2TR
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: June 21, 2022

Study information

• Verified date: June 2024
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Activity

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Center for Advancing Translational Sciences (NCATS), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline and 3 months
Other	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.	Baseline and 3 months
Other	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	Baseline and 3 months
Other	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.	Baseline and 3 months
Other	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.	Baseline and 3 months
Other	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.	Baseline
Other	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.	Baseline and 3 months
Other	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	Baseline and 3 months
Other	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.	Baseline and 3 months
Other	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.	Baseline and 3 months
Other	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	Baseline and 3 months
Other	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	Baseline and 3 months
Other	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.	Baseline and 3 months
Other	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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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.	Baseline and 3 months
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).	Baseline and 3 months
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	Baseline and 3 months
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.	Baseline and 3 months