Clinical trial NCT02762604: Motor Imagery Intervention for Improving Gait and Cognition in the Elderly
Official title: Motor Imagery Intervention for Improving Gait and Cognition in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-05-05
Enrollment: 49
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Walking Speed During Single and Dual-task Walking Conditions
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Cognitive Performance During Walking While Talking
timeFrame: Baseline and 3 months
measure: Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions
timeFrame: Baseline and 3 months
measure: Change in Trail Making Test Form A
timeFrame: Baseline and 3 months
measure: Change in Trail Making Test Form B
timeFrame: Baseline and 3 months
measure: Change in Trail Making Test Form B Minus Form A
timeFrame: Baseline and 3 months
measure: Change in Letter Number Sequencing Task Score
timeFrame: Baseline and 3 months
measure: Change in Stroop Interference Test: Color-Word Minus Color Score
timeFrame: Baseline and 3 months
measure: Change in Flanker Interference Task
timeFrame: Baseline and 3 months
measure: Change in Stride Length
timeFrame: Baseline and 3 months
measure: Change in Gait Variability
timeFrame: Baseline and 3 months
measure: Change in Gait Domains
timeFrame: Baseline and 3 months
Other outcomes:
measure: Change in Free Cued Serial Recall Test
timeFrame: Baseline and 3 months
measure: Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline and 3 months
measure: Change in Controlled Oral Word Fluency Test
timeFrame: Baseline and 3 months
measure: Change in Semantic Fluency Test
timeFrame: Baseline and 3 months
measure: Change in Digit Symbol Substitution
timeFrame: Baseline and 3 months
measure: Modified Short Physical Performance Battery (SPPB) at Baseline
timeFrame: Baseline
measure: Change in Immediate Maze Task Performance
timeFrame: Baseline and 3 months
measure: Change in Delayed Maze Task Performance
timeFrame: Baseline and 3 months
measure: Change in Errors on Maze Task
timeFrame: Baseline and 3 months
measure: Change in Geriatric Depression Scale
timeFrame: Baseline and 3 months
measure: Change in Beck Anxiety Inventory
timeFrame: Baseline and 3 months
measure: Change in Gray Matter Cortical Thickness
timeFrame: Baseline and 3 months
measure: Change in White Matter Integrity
timeFrame: Baseline and 3 months
measure: Change in White Matter Hyperintensities
timeFrame: Baseline and 3 months
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Helena M Blumen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumen HM, Verghese J. Motor imagery of walking and walking while talking: a pilot randomized-controlled trial protocol for older adults. Neurodegener Dis Manag. 2017 Dec;7(6):353-363. doi: 10.2217/nmt-2017-0024. Epub 2017 Nov 22.