Graded Motor Imagery and Fall Risk in Older Adults (GMI)

May 8, 2023 updated by: Kevin Farrell, St. Ambrose University

Graded Motor Imagery and Fall Risk in Older Adults: An Exploratory Study

To determine if there is any carry over effect of sensation training for the feet, officially called Graded Motor Imagery (GMI), will impact balance and fall risk factors in older individuals. This will be looked at to see if there is a difference in balance and sensation before and right after the training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In order to increase acuity of body maps, various tactile and movement-based strategies have been recommended and supported for research focusing on sensory discrimination. Current evidence, specific to painful conditions related to altered cortical mapping, have shown growing evidence in reducing pain and disability. In regards to it's ability to alter foot pain in older adults and decreasing fall risk, prior conference case study and case series presentations have suggested potential clinical benefit, but it has not been formally studied. The aim of this study is to determine if a sensory discrimination training for feet in older adults can alleviate pain, improve sensory discrimination, and also decrease fall risk. Specifically, does a 20 minute training session improve pain, balance (Brief-BEST test), and sensory discrimination in individuals over 65 years of age. Secondary analysis may exam characteristics that best identify those who benefit from this training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Davenport, Iowa, United States, 52803
        • St. Ambrose University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A convenience sample of older adults (65 and older) will be recruited for the study.

Description

Inclusion Criteria:

  • Be able to read and understand English
  • Be over the age of 65
  • Be independent with ambulation (with or without an assistive device)
  • Not have any skin condition or injury to the plantar or dorsal part of the foot
  • Have the visual ability to view images on a tablet to partake in a test

Exclusion Criteria:

  • No existing skin conditions on the bottom of the foot that would impair sensation
  • No current injury to the plantar or dorsal side of the foot
  • No prior surgery or major injury to the plantar or dorsal side of the foot
  • Lacking sensation in the foot
  • Unable to read and understand English
  • Lacking ability to view images on a tablet to partake in a test
  • Unable to ambulate (with or without an assistive device)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental group
A convenience sample of older adults (65 and older).
Procedure: Graded Motor Imagery
GMI consisting of education, sensory integration of the foot using contact, flooring samples, immersion, and two point discrimination.
Other Names:
  • GMI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lower extremity pain rating
Time Frame: self-reported, change from before to immediately after treatment
Change (from before treatment to immediately after treatment) in pain for the lower extremity using the numeric pain rating scale (NPRS - 0 to 10 where 0 = no pain and 10 + maximum pain)
self-reported, change from before to immediately after treatment
Laterality Speed
Time Frame: tested for 60 seconds before and immediately after treatment
Change (from before treatment to immediately after treatment) in speed of foot recognition using Recognize (TM) (speed in seconds to recognize each of 40 images as right or left foot)
tested for 60 seconds before and immediately after treatment
Laterality Accuracy
Time Frame: tested for 60 seconds before and immediately after treatment
Change (from before treatment to immediately after treatment) in accuracy of foot recognition using Recognize (TM) (percent accurately correctly identified as right or left foot of those 40 images)
tested for 60 seconds before and immediately after treatment
Balance / fall risk
Time Frame: Assessed before and immediately after treatment
Change (from before treatment to immediately after treatment) in Brief-BESTest (6 task subsets to assess static and dynamic balance) (0 - 15 scale where 0 - lowest score / unstable and 15 = highest / no balance issues)
Assessed before and immediately after treatment
Nerve Sensitivity Dorsum of dominant hand
Time Frame: Assessed before and immediately after treatment
Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of web space of dominant hand (in pounds)
Assessed before and immediately after treatment
Nerve Sensitivity Dorsum of Right Foot
Time Frame: Assessed before and immediately after treatment
Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of right foot (in pounds)
Assessed before and immediately after treatment
Nerve Sensitivity Dorsum of Left Foot
Time Frame: Assessed before and immediately after treatment
Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of left foot (in pounds)
Assessed before and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Ambrose University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Farrell, PT, PhD, St. Ambrose University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • StAmbroseU GMI fall risk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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