Motor ActivityNCT02762604
Motor Imagery Intervention for Improving Gait and Cognition in the Elderly
A study testing Imagined Gait Intervention and Visual Imagery Intervention in people with Motor Activity, run by Albert Einstein College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Imagined Gait Intervention and Visual Imagery Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
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.
Read the 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.
- Conditions
- Motor Activity
- Being tested
- Imagined Gait Intervention, Visual Imagery Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagined Gait InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Visual Imagery Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (11)
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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).
Measured: Baseline and 3 months
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
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start16 Oct 2017
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Helena M Blumen, Ph.D, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762604
- Sponsor's protocol ID
- 2014-3633
- Other IDs
- K01AG049829, KL2TR001071
- Status last verified
- Jun 2024
- First submitted
- 3 May 2016
- Last updated
- 4 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29165011
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery Intervention for Improving Gait and Cognition in the Elderly
- ClinicalTrials.gov ID
- NCT02762604
- Acronym / sponsor ID
- 2014-3633
- Conditions
- Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 4 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imagined Gait Intervention | Experimental | Behavioral: Imagined Gait InterventionDuring 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. |
| Visual Imagery Intervention | Active comparator | Behavioral: Visual Imagery InterventionDuring 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagined Gait InterventionPhone-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. | Behavioural | Imagined Gait Intervention |
| Visual Imagery InterventionPhone-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. | Behavioural | Visual Imagery Intervention |
Primary outcome
Change in Walking Speed During Single and Dual-task Walking Conditions
Time frame: 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.
11 secondary outcomes
Change in Cognitive Performance During Walking While Talking
Time frame: Baseline and 3 months
Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions
Time frame: Baseline and 3 months
Change in Trail Making Test Form A
Time frame: Baseline and 3 months
Change in Trail Making Test Form B
Time frame: Baseline and 3 months
Change in Trail Making Test Form B Minus Form A
Time frame: Baseline and 3 months
Change in Letter Number Sequencing Task Score
Time frame: Baseline and 3 months
Change in Stroop Interference Test: Color-Word Minus Color Score
Time frame: Baseline and 3 months
Change in Flanker Interference Task
Time frame: Baseline and 3 months
Change in Stride Length
Time frame: Baseline and 3 months
Change in Gait Variability
Time frame: Baseline and 3 months
Change in Gait Domains
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29165011Blumen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena M Blumen, Ph.D principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagined Gait Intervention and Visual Imagery Intervention in people with Motor Activity, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Speed During Single and Dual-task Walking Conditions (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02762604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.