A Novel Approach to Plantar Fasciitis in the Aging Population
NAPA
2 other identifiers
interventional
138
1 country
1
Brief Summary
The goal of this study is to determine whether improving foot strength through foot exercises and minimal footwear can provide improved outcomes over the short and long term. The main research question it aims to answer is: Can the minimal footwear intervention be used to improve the health of aging adults with plantar fasciitis?? Participants will be randomized into 2 groups. One group will receive minimal shoes and foot strengthening and foot flexibility exercises. The other group will receive supportive shoes, foot orthotic device and foot flexibility exercises. Participants' step count will also be monitored. Researchers will compare pain and physical function between the minimal footwear (MF) and the foot orthotic (FO) groups at each of the follow-up sessions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2023
1 active site
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
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
August 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMay 21, 2024
May 1, 2024
1.8 years
February 6, 2023
May 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (33)
Foot Health Status Questionnaire (FHSQ)
It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
Baseline
Foot Health Status Questionnaire (FHSQ)
It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
3 months
Foot Health Status Questionnaire (FHSQ)
It is a self-report questionnaire that relies on participant recall over the previous 7 days. The FHSQ incorporates questions that address foot pain, function, footwear, and general health and activity levels. It is ranged from 1 to 100, where 0 indicates poor foot health and 100 is excellent foot health score. High reliability and validity have been established for it.
6 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
Baseline
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
1 month
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
2 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
3 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
4 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
5 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
6 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
7 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
8 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
9 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
10 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
11 months
Foot pain
Over the past 7 days on a Numerical Pain Rating Scale from 0 -10 (with 0 being no pain and 10 being the worst pain imaginable) will be asked to participants. The average of weekly pain will be calculated for each months. The questions are as below; 1. What is the worst your pain has been upon first step in the morning. 2. What is the worst your pain has been during the day. 3. Do you have any other foot or lower extremity pain that is limiting your walking?
12 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
Baseline
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
1 month
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
2 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
3 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
4 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
5 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
6 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
7 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
8 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
9 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
10 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
11 months
Step counts
Over the past 7 days of step counts will be monitored via Garmin watch. The average of weekly step counts will be calculated for each months. The Garmin watch device was chosen as it has a 1 yr battery life eliminating the need for recharging and is waterproof. It can store 30 days worth of data and also syncs to an app on the participant's smart phone or computer. Therefore, we can access the data directly, eliminating the need for the participants to keep track of their data.
12 months
Global Rating Outcome Change (GROC)
GRC scale asks that a person assess his or her current health status, recall that status at a previous time-point. The question is as below. With respect to you previous pain, how would you describe yourself now?
3 months
Global Rating Outcome Change (GROC)
GROC scale asks that a person assess his or her current health status, recall that status at a previous time-point. The question is as below. With respect to you previous pain, how would you describe yourself now?
6 months
Patient Acceptable Symptom State (PASS)
This is a single assessment self-reported tool. The question is as below. Taking into account your previous pain status, do you consider your foot health satisfactory?
3 months
Patient Acceptable Symptom State (PASS)
This is a single assessment self-reported tool. The question is as below. Taking into account your previous pain status, do you consider your foot health satisfactory?
6 months
Secondary Outcomes (12)
International Physical Activity Questionnaire (IPAQ)
Baseline
International Physical Activity Questionnaire (IPAQ)
3 months
International Physical Activity Questionnaire (IPAQ)
6 months
Static and dynamic balance
Baseline
Static and dynamic balance
3 months
- +7 more secondary outcomes
Study Arms (2)
Minimal Footwear (Vivobarefoot)
EXPERIMENTALThe experimental intervention involves the combination of foot strengthening/stretching and minimal footwear to promote the foot strengthening beyond the exercise program to mitigate weakening from chronic support.
Supportive Footwear
ACTIVE COMPARATORThe control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.
Interventions
Flexible shoes that do not provide support and exercises aimed at increasing the strength of plantar intrinsic and extrinsic foot muscles along with foot flexibility exercises aimed at increasing the range of motion of the foot and ankle
sturdy supportive shoes fitted with supportive foot orthotic devices and foot flexibility exercises aimed at increasing the range of motion of the foot and ankle
Eligibility Criteria
You may qualify if:
- Active plantar fasciitis for a minimum of 6 months. 2. Heel/arch pain on first step in the morning, 3. Heel/arch pain with prolonged standing (\>15 min), 4. Heel/arch pain with prolonged walking (\>15 min), 5. Be able to stand and walk for 10 minutes with little or no pain (\<3/10 on a NRPS).
You may not qualify if:
- Having systemic disease such as diabetes, gout, arthritis, neuropathy, surgical reconstructions
- Having a history of heel surgery or had a steroid injection for heel pain in the past 6 months.
- Used foot orthoses less than 3 months before start date of study.
- Having used minimal shoes at any time in the past.
- No special or vulnerable populations will be recruited.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- University of Hartfordcollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of South Flroida
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 6, 2023
First Posted
April 28, 2023
Study Start
August 7, 2023
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
May 21, 2024
Record last verified: 2024-05