- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05715112
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
Completed
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
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Iowa
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Davenport, Iowa, United States, 52803
- St. Ambrose University
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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
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 |
Intervention / Treatment |
---|---|
Experimental group
A convenience sample of older adults (65 and older).
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GMI consisting of education, sensory integration of the foot using contact, flooring samples, immersion, and two point discrimination.
Other Names:
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What is the study measuring?
Primary Outcome Measures
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)
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self-reported, change from before to immediately after treatment
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Laterality Speed
Time Frame: tested for 60 seconds before and immediately after treatment
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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)
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tested for 60 seconds before and immediately after treatment
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Laterality Accuracy
Time Frame: tested for 60 seconds before and immediately after treatment
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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)
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tested for 60 seconds before and immediately after treatment
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Balance / fall risk
Time Frame: Assessed before and immediately after treatment
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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)
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Assessed before and immediately after treatment
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Nerve Sensitivity Dorsum of dominant hand
Time Frame: Assessed before and immediately after treatment
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Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of web space of dominant hand (in pounds)
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Assessed before and immediately after treatment
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Nerve Sensitivity Dorsum of Right Foot
Time Frame: Assessed before and immediately after treatment
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Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of right foot (in pounds)
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Assessed before and immediately after treatment
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Nerve Sensitivity Dorsum of Left Foot
Time Frame: Assessed before and immediately after treatment
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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
Investigators
- 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)
August 17, 2022
Primary Completion (Actual)
August 18, 2022
Study Completion (Actual)
August 18, 2022
Study Registration Dates
First Submitted
January 13, 2023
First Submitted That Met QC Criteria
February 4, 2023
First Posted (Actual)
February 6, 2023
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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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