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BalanceGMINCT05715112

Graded Motor Imagery and Fall Risk in Older Adults

An observational study of Balance and Fall Risk, run by St. Ambrose University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Balance, Fall Risk
What is being tested?
Graded Motor Imagery
Type of treatment
Surgery or procedure
How many people
42 participants
Where
1 siteUnited States
Study dates
17 Aug 2022to 18 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Ambrose University

    Davenport, Iowa, 52803

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Balance, Fall Risk
Being tested
Graded Motor Imagery
Keywords
Graded Motor Imagery, Balance, Fall Risk, Elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Graded Motor ImageryProcedure or surgery

    Also called GMI

    GMI consisting of education, sensory integration of the foot using contact, flooring samples, immersion, and two point discrimination.

Study groups in NCT05715112
Study groupRoleWhat they receive
Experimental groupA convenience sample of older adults (65 and older).
Receives: Procedure: Graded Motor Imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower extremity pain rating

    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)

    Measured: self-reported, change from before to immediately after treatment

  2. Laterality Speed

    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)

    Measured: tested for 60 seconds before and immediately after treatment

  3. Laterality Accuracy

    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)

    Measured: tested for 60 seconds before and immediately after treatment

  4. Balance / fall risk

    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)

    Measured: Assessed before and immediately after treatment

  5. Nerve Sensitivity Dorsum of dominant hand

    Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of web space of dominant hand (in pounds)

    Measured: Assessed before and immediately after treatment

  6. Nerve Sensitivity Dorsum of Right Foot

    Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of right foot (in pounds)

    Measured: Assessed before and immediately after treatment

  7. Nerve Sensitivity Dorsum of Left Foot

    Change (from before treatment to immediately after treatment) in Pain Pressure Threshold (PPT) on dorsum of left foot (in pounds)

    Measured: Assessed before and immediately after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start17 Aug 2022
  3. Primary completion18 Aug 2022
  4. Study completion18 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05715112
Sponsor's protocol ID
StAmbroseU GMI fall risk
Acronym
GMI
Status last verified
May 2023
First submitted
13 Jan 2023
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Balance and Fall Risk, run by St. Ambrose University 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 5 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 10 May 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Lower extremity pain rating (time frame: self-reported, change from before to immediately after treatment). The study lists 7 primary outcomes in all. 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 NCT05715112.

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 10 May 2023.

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