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Motor Imagery Intervention for Improving Gait and Cognition in the Elderly

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ClinicalTrials.gov Identifier: NCT02762604
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Helena Blumen, Albert Einstein College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Motor Activity Behavioral: Imagined Gait Intervention Behavioral: Visual Imagery Intervention Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Motor Imagery Intervention for Improving Gait and Cognition in the Elderly
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Active Comparator: 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.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in walking speed during single and/or dual-task walking conditions [ Time Frame: 3 months ]
    Improvement in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway


Secondary Outcome Measures :
  1. Improvement in cognitive performance during talking walking while talking [ Time Frame: 3 months ]
    Increased number of correct letters generated during walking while talking

  2. Change in blood-oxygen-level-dependent signal during single and/or dual-task imagined walking conditions [ Time Frame: 3 months ]
    Change in blood-oxygen-level-dependent signal during single and/or dual-task imagined walking conditions measured with functional magnetic resonance imaging

  3. Improvement on Trail Making Test form A [ Time Frame: 3 Months ]
    Improvement on Trail Making Test form A, a timed measure of attention and processing speed. Scoring is based on the time required to complete the task and on accuracy

  4. Improvement on Trail Making Test form B [ Time Frame: 3 months ]
    Improvements on Trail Making Test form B, a timed measure of attention, processing speed and set-shifting. Scoring is based on the time required to complete the task and on accuracy

  5. Improvement on Trail Making Test form B minus A [ Time Frame: 3 months ]
    Improvements on Trail Making Test form B minus A, a timed measure of set-shifting. Scoring is based on the change in time and accuracy between completing form B compared to form A.

  6. Improvement on the Letter Number Sequencing Task [ Time Frame: 3 months ]
    Improvement on the letter number sequencing task, a measure of item manipulation. Scoring is based on the number of correctly completed sequences

  7. Improvement in Stroop Interference: Color-Word minus Color score [ Time Frame: 3 months ]
    Improvement on Stroop Interference: Color-Word (incongruent trials) minus Color (congruent trials) score. Scoring is based on the time and accuracy to complete incongruent relative to congruent trials. A measure of response competition and interference.

  8. Improvement on the Flanker Interference Task [ Time Frame: 3 months ]
    Improvement on the Flanker Interference: Incongruent minus Congruent trials. Scoring is based on the time and accuracy of responses during incongruent relative to congruent trials. A measure of response competition and interference

  9. Stride Length [ Time Frame: 3 months ]
    Change in stride length collected during normal pace walking and walking while talking conditions on an instrumented walkway

  10. Gait Variability [ Time Frame: 3 months ]
    Change in gait variability measured in standard deviation units, collected during normal pace walking and walking while talking on an instrumented walkway.

  11. Gait Domains [ Time Frame: 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


Other Outcome Measures:
  1. Free Cued Serial Recall Test [ Time Frame: 3 Months ]
    Improved free recall performance on the free cued serial recall test, a measure of verbal learning and memory

  2. Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 3 months ]
    Improved figure copy recall performance on the RBANS, a measure of spatial learning and memory

  3. Controlled Oral Word Fluency Test [ Time Frame: 3 months ]
    Increased number of correct words generated on the controlled oral word fluency test, a measure of language processing

  4. Semantic Fluency Test [ Time Frame: 3 Months ]
    Increased total number of correct words generated for each category on the semantic fluency test, a measure of language processing

  5. Digit Symbol Substitution [ Time Frame: 3 months ]
    Increased number of correct digit symbols generate on the digit symbol substitution test, a measure of processing speed

  6. Short Physical Performance Battery (SPPB) [ Time Frame: 3 months ]
    Improved performance on the SPPB, a measure of lower extremity function

  7. Immediate Maze Task Performance [ Time Frame: 3 months ]
    Improved immediate maze performance (time), a measure of spatial navigation and memory

  8. Delayed Maze Task Performance [ Time Frame: 3 months ]
    Improved delayed maze performance (time),a measure of spatial navigation and memory

  9. Errors on Maze Task [ Time Frame: 3 months ]
    Reduced number of errors during maze performance,a measure of spatial navigation and memory

  10. Geriatric Depression Scale [ Time Frame: 3 months ]
    Reduction of depressive symptoms

  11. Beck Anxiety Inventory [ Time Frame: 3 months ]
    Reduction of symptoms of anxiety

  12. Gray Matter Volume/Cortical Thickness [ Time Frame: 3 months ]
    Change in Gray Matter Volume/Cortical Thickness obtained from T1-weighted structural images

  13. White Matter Integrity [ Time Frame: 3 Months ]
    Change in White Matter Integrity obtained from diffusion-weighted imaging

  14. White Matter Hyperintensities [ Time Frame: 3 months ]
    Change in White Matter Hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762604


Contacts
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Contact: Helena M Blumen, Ph.D 7184303810 helena.blumen@einstein.yu.edu

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Dakota Egglefield    718-430-3972      
Contact: Crismeldy Veloz    7184307344      
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Helena M Blumen, Ph.D Albert Einstein College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Helena Blumen, Assistant Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02762604    
Other Study ID Numbers: 2014-3633
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No