NCT02762604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 4, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

4.7 years

First QC Date

May 3, 2016

Results QC Date

June 16, 2023

Last Update Submit

June 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in Cognitive Performance During Walking While Talking

    Baseline and 3 months

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

    Baseline and 3 months

  • Change in Trail Making Test Form A

    Baseline and 3 months

  • Change in Trail Making Test Form B

    Baseline and 3 months

  • Change in Trail Making Test Form B Minus Form A

    Baseline and 3 months

  • +6 more secondary outcomes

Other Outcomes (14)

  • Change in Free Cued Serial Recall Test

    Baseline and 3 months

  • Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Baseline and 3 months

  • Change in Controlled Oral Word Fluency Test

    Baseline and 3 months

  • +11 more other outcomes

Study Arms (2)

Imagined Gait Intervention

EXPERIMENTAL

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

Visual Imagery Intervention

ACTIVE COMPARATOR

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

Interventions

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 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

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Helena Blumen
Organization
Albert Einstein College of Medicine

Study Officials

  • Helena M Blumen, Ph.D

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

October 16, 2017

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

June 4, 2024

Results First Posted

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations