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Completed

NCT Number: NCT05715112

Graded Motor Imagery and Fall Risk in Older Adults

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.

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Key information

Conditions

Balance Fall Risk

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Ambrose University

Davenport, Iowa, 52803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Graded Motor Imagery

Procedure

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

Other names: GMI

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

St. Ambrose University

Other

Registry information

Official study title

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

Acronym: GMI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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