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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05715112
Other study ID # StAmbroseU GMI fall risk
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2022
Est. completion date August 18, 2022

Study information

Verified date May 2023
Source St. Ambrose University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date August 18, 2022
Est. primary completion date August 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Graded Motor Imagery
GMI consisting of education, sensory integration of the foot using contact, flooring samples, immersion, and two point discrimination.

Locations

Country Name City State
United States St. Ambrose University Davenport Iowa

Sponsors (1)

Lead Sponsor Collaborator
St. Ambrose University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) self-reported, change from before to immediately after treatment
Primary 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) tested for 60 seconds before and immediately after treatment
Primary 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) tested for 60 seconds before and immediately after treatment
Primary 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) Assessed before and immediately after treatment
Primary 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) Assessed before and immediately after treatment
Primary 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) Assessed before and immediately after treatment
Primary 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) Assessed before and immediately after treatment
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