NCT05715112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1 day

First QC Date

January 13, 2023

Last Update Submit

May 8, 2023

Conditions

Keywords

Graded Motor ImageryBalanceFall RiskElderly

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Experimental group

A convenience sample of older adults (65 and older).

Procedure: Graded Motor Imagery

Interventions

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

Also known as: GMI
Experimental group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Ambrose University

Davenport, Iowa, 52803, United States

Location

Study Officials

  • Kevin Farrell, PT, PhD

    St. Ambrose University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus / Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 6, 2023

Study Start

August 17, 2022

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations