NCT02762604

Motor Imagery Intervention for Improving Gait and Cognition in the Elderly

Completed NA Results posted Last updated 4 June 2024

What this trial tests

NA trial testing Imagined Gait Intervention in Motor Activity in 49 participants. Completed in 21 June 2022.

Timeline

16 October 2017

Primary endpoint
21 June 2022

21 June 2022

Quick facts

Lead sponsor	Albert Einstein College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	49
Start date	16 October 2017
Primary completion	21 June 2022
Estimated completion	21 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Imagined Gait Intervention
• Visual Imagery Intervention

Conditions studied

• Motor Activity — all drugs for Motor Activity →

Sponsor

Albert Einstein College of Medicine

Who can join

Adults 65 to 85, any sex, with Motor Activity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Walking Speed During Single and Dual-task Walking Conditions Primary · 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.

Gait speed (normal pace)

Group	Value	95% CI
Imagined Gait Intervention	-3.33	± 14.13
Visual Imagery Intervention	-0.53	± 25.77

Gait speed (walking-while-talking)

Group	Value	95% CI
Imagined Gait Intervention	5.89	± 20.44
Visual Imagery Intervention	-10.55	± 15.68

Change in Cognitive Performance During Walking While Talking Secondary · 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-

Group	Value	95% CI
Imagined Gait Intervention	0.19	± 1.46
Visual Imagery Intervention	-1.54	± 1.50

Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	-2.98	± 19.35
Visual Imagery Intervention	-3.07	± 11.89

Change in Trail Making Test Form A Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	-0.72	± 19.16
Visual Imagery Intervention	-1.45	± 5.93

Change in Trail Making Test Form B Secondary · 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

Group	Value	95% CI
Imagined Gait Intervention	4.49	± 54.18
Visual Imagery Intervention	-9.54	± 19.74

Change in Trail Making Test Form B Minus Form A Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	5.22	± 50.28
Visual Imagery Intervention	-8.09	± 23.09

Change in Letter Number Sequencing Task Score Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	-0.55	± 2.15
Visual Imagery Intervention	0.61	± 1.84

Change in Stroop Interference Test: Color-Word Minus Color Score Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	-8.38	± 30.14
Visual Imagery Intervention	-14.47	± 31.37

Change in Flanker Interference Task Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	-49.55	± 108.85
Visual Imagery Intervention	-94.69	± 93.97

Change in Stride Length Secondary · 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).

Group	Value	95% CI
Imagined Gait Intervention	3.08	± 9.33
Visual Imagery Intervention	-11.49	± 13.37

Change in Gait Variability Secondary · 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

Group	Value	95% CI
Imagined Gait Intervention	-0.17	± 2.45
Visual Imagery Intervention	1.81	± 1.56

Change in Free Cued Serial Recall Test Secondary · 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.

Group	Value	95% CI
Imagined Gait Intervention	1.14	± 13.01
Visual Imagery Intervention	-1.02	± 5.81

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Imagined Gait Intervention

Serious: 0/25 (0%)

Deaths: 0/25

Visual Imagery Intervention

Serious: 1/24 (4%)

Deaths: 0/24

Serious adverse events (1 terms)

Reaction	System	Imagined Gait Intervention	Visual Imagery Intervention
Pneumonia	Infections and infestations	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Imagined Gait Intervention	Visual Imagery Intervention
Back/shoulder pain	Musculoskeletal and connective tissue disorders	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—
Fall	Musculoskeletal and connective tissue disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Tinnitus	Ear and labyrinth disorders	—	—
Pain in lower extremities	Musculoskeletal and connective tissue disorders	—	—
Pain in upper extremities	Musculoskeletal and connective tissue disorders	—	—
Enlarged prostate	Reproductive system and breast disorders	—	—
Dizziness	Ear and labyrinth disorders	—	—

Most-reported serious reactions: Pneumonia.

Data from ClinicalTrials.gov NCT02762604 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Motor imagery of walking and walking while talking: a pilot randomized-controlled trial protocol for older adults.
   Blumen HM, Verghese J. · · 2017 · cited 3× · PMID 29165011 · DOI 10.2217/nmt-2017-0024