Plantar Fasciitis, ChronicPhase 2NAPANCT05834491
A Novel Approach to Plantar Fasciitis in the Aging Population
A Phase 2 study testing minimal shoes and foot strengthening and flexibility exercises and Supportive Footwear, foot orthotic device and foot flexibility exercises in people with Plantar Fasciitis, Chronic, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Plantar Fasciitis, Chronic
- What is being tested?
- minimal shoes and foot strengthening and flexibility exercises and Supportive Footwear, foot orthotic device and foot flexibility exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 31 May 2025
- Phase
- Phase 2
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Flroida
Tampa, Florida, 33612
Irene Davis, Professor
About this study
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.
Read the detailed description
Twenty five percent of older adults experience foot pain. Plantar fasciitis, a repetitive strain injury, is one of the most common causes of foot pain in this population. Ten percent of aging adults experience plantar fasciitis with 50% of the cases being disabling. Foot pain can lead to other problems such as reduced mobility, depression and prescription medication use, leading to a reduced quality of life. Foot pain has been related to foot weakness, reduced static and dynamic balance, and reduced walking speed in aging adults.
The standard of care for plantar fasciitis is to brace the arch with foot orthoses and supportive shoes, thereby reducing the strain on the plantar fascia. However, arch support has been shown to be an ineffective long-term strategy for reducing foot pain, as well as leading to intrinsic foot muscle atrophy. As plantar fasciitis is associated with this atrophy, treating it with chronic arch support only increases the risk for recurrence. In fact, there is a 50% recurrence rate and a 45.6% risk of having plantar fasciitis 10 years after the onset of symptoms, and this risk increases with age.
Minimal shoes are designed to allow the foot to function naturally, as if barefoot, which have already been successfully implemented in older adults for the treatment of knee osteoarthritis. Minimal shoes are highly flexible and lack the support of conventional footwear. This places a greater demand on the foot muscles, which promotes strengthening. Indeed, studies of gradual transitioning to walking in minimal shoes have demonstrated significant increases in intrinsic foot muscle size and strength. Stronger foot intrinsic foot muscles have been shown to reduce the strain on the plantar fascia with each step, thereby reducing the risk of developing plantar fasciitis. This is especially important in the older population who develop muscle weakness as they age.
The overall objective of this study is to improve treatment interventions for plantar fasciitis in aging adults. The central hypothesis of this research is that strong intrinsic foot muscles will reduce the strain on the plantar fascia. This, in turn will result in resolution of pain, with less recurrence of plantar fasciitis than the standard of care. The investigators will test this hypothesis by comparing an intervention of stretching, foot orthoses and supportive shoes to one of foot stretching, strengthening and transition to minimal footwear. Training the foot of a patient with plantar fasciitis to function with less support is a significant paradigm shift from interventions aimed at passively supporting the foot. However, the investigators hypothesize that the dynamic stability of the foot muscles will be more effective than a static foot orthosis, that has been shown to promote foot weakening. The investigators will assess outcomes of foot pain, functional activities, and muscle strength, size and function at the 3- and 6-month follow-up, and the incidence of recurrence of plantar fasciitis at the 12 month time point.
- Conditions
- Plantar Fasciitis, Chronic
- Being tested
- minimal shoes and foot strengthening and flexibility exercises, Supportive Footwear, foot orthotic device and foot flexibility exercises
- Keywords
- minimal footwear, pain, function, strengthening
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal shoes and foot strengthening and flexibility exercisesDevice
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
Supportive Footwear, foot orthotic device and foot flexibility exercisesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Minimal Footwear (Vivobarefoot) | Experimental | The 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. Receives: Device: minimal shoes and foot strengthening and flexibility exercises |
| Supportive Footwear | Active comparator | The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses. Receives: Device: Supportive Footwear, foot orthotic device and foot flexibility exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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;
- What is the worst your pain has been upon first step in the morning.
- What is the worst your pain has been during the day.
- Do you have any other foot or lower extremity pain that is limiting your walking?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 6 months
Secondary outcomes (12)
International Physical Activity Questionnaire (IPAQ)
It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
Measured: Baseline
International Physical Activity Questionnaire (IPAQ)
It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
Measured: 3 months
International Physical Activity Questionnaire (IPAQ)
It is a self-report questionnaire that quantifies physical activity over the previous 7 days. It includes questions specific to time spent walking, as well as sedentary behavior such as time spent sitting. The scale of IPAQ is between 500 -10000 MET. High reliability and validity have been established for it.
Measured: 6 months
Static and dynamic balance
This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
Measured: Baseline
Static and dynamic balance
This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
Measured: 3 months
Static and dynamic balance
This test has been used as a measure of physical performance in older adults. Participants will stand, barefoot and on one leg, on a force plate that is at the center of a grid marked by 3 pieces of tape. They will perform maximal reaches with the non-supporting leg along each of the taped lines (Anterior, Posterior-Lateral, and Posterior-Medial). The maximum distance they reached will be measured in centimeter.
Measured: 6 months
Muscles size of cross sectional area
It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
Measured: Baseline
Muscles size of cross sectional area
It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
Measured: 3 months
Muscles size of cross sectional area
It will be measured with ultrasound imaging. These muscles are the flexor digitorum brevis (FDB), abductor hallicus (ABDH), abductor digiti minimi (ADM) and quadratus plantae (QP). The ultrasound probe (GE Logiq S8, 6-15Mhz linear array) with gel will be placed in alignment with internal bony landmarks (e.g. metatarsal head and navicular tuberosity) or external landmarks (e.g. 30% and 50% of leg length from knee joint line marked on the skin surface) to standardize measurement location.
Measured: 6 months
Muscle Strength
Strength of the intrinsic muscles will be measured with a force dynamometer.
Measured: Baseline
Muscle Strength
Strength of the intrinsic muscles will be measured with a force dynamometer.
Measured: 3 months
Muscle Strength
Strength of the intrinsic muscles will be measured with a force dynamometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start7 Aug 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis, ChronicStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hartford, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Irene Davis, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834491
- Sponsor's protocol ID
- STUDY004876
- Other IDs
- 1R01AG071646
- Acronym
- NAPA
- Status last verified
- May 2024
- First submitted
- 6 Feb 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Plantar Fasciitis in the Aging Population
- ClinicalTrials.gov ID
- NCT05834491
- Acronym / sponsor ID
- NAPA / STUDY004876
- Conditions
- Plantar Fasciitis, Chronic
- Keywords
- minimal footwear, pain, function, strengthening
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- University of Hartford, National Institute on Aging (NIA)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twenty five percent of older adults experience foot pain. Plantar fasciitis, a repetitive strain injury, is one of the most common causes of foot pain in this population. Ten percent of aging adults experience plantar fasciitis with 50% of the cases being disabling. Foot pain can lead to other problems such as reduced mobility, depression and prescription medication use, leading to a reduced quality of life. Foot pain has been related to foot weakness, reduced static and dynamic balance, and reduced walking speed in aging adults.
The standard of care for plantar fasciitis is to brace the arch with foot orthoses and supportive shoes, thereby reducing the strain on the plantar fascia. However, arch support has been shown to be an ineffective long-term strategy for reducing foot pain, as well as leading to intrinsic foot muscle atrophy. As plantar fasciitis is associated with this atrophy, treating it with chronic arch support only increases the risk for recurrence. In fact, there is a 50% recurrence rate and a 45.6% risk of having plantar fasciitis 10 years after the onset of symptoms, and this risk increases with age.
Minimal shoes are designed to allow the foot to function naturally, as if barefoot, which have already been successfully implemented in older adults for the treatment of knee osteoarthritis. Minimal shoes are highly flexible and lack the support of conventional footwear. This places a greater demand on the foot muscles, which promotes strengthening. Indeed, studies of gradual transitioning to walking in minimal shoes have demonstrated significant increases in intrinsic foot muscle size and strength. Stronger foot intrinsic foot muscles have been shown to reduce the strain on the plantar fascia with each step, thereby reducing the risk of developing plantar fasciitis. This is especially important in the older population who develop muscle weakness as they age.
The overall objective of this study is to improve treatment interventions for plantar fasciitis in aging adults. The central hypothesis of this research is that strong intrinsic foot muscles will reduce the strain on the plantar fascia. This, in turn will result in resolution of pain, with less recurrence of plantar fasciitis than the standard of care. The investigators will test this hypothesis by comparing an intervention of stretching, foot orthoses and supportive shoes to one of foot stretching, strengthening and transition to minimal footwear. Training the foot of a patient with plantar fasciitis to function with less support is a significant paradigm shift from interventions aimed at passively supporting the foot. However, the investigators hypothesize that the dynamic stability of the foot muscles will be more effective than a static foot orthosis, that has been shown to promote foot weakening. The investigators will assess outcomes of foot pain, functional activities, and muscle strength, size and function at the 3- and 6-month follow-up, and the incidence of recurrence of plantar fasciitis at the 12 month time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Footwear (Vivobarefoot) | Experimental | Device: minimal shoes and foot strengthening and flexibility exercisesThe 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 comparator | Device: Supportive Footwear, foot orthotic device and foot flexibility exercisesThe control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimal shoes and foot strengthening and flexibility exercisesFlexible 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 | Device | Minimal Footwear (Vivobarefoot) |
| Supportive Footwear, foot orthotic device and foot flexibility exercisessturdy supportive shoes fitted with supportive foot orthotic devices and foot flexibility exercises aimed at increasing the range of motion of the foot and ankle | Device | Supportive Footwear |
Primary outcome
Foot Health Status Questionnaire (FHSQ)
Time frame: Baseline
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.
Foot Health Status Questionnaire (FHSQ)
Time frame: 3 months
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.
Foot Health Status Questionnaire (FHSQ)
Time frame: 6 months
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.
Foot pain
Time frame: Baseline
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?
Foot pain
Time frame: 1 month
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?
Foot pain
Time frame: 2 months
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?
Foot pain
Time frame: 3 months
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?
Foot pain
Time frame: 4 months
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?
Foot pain
Time frame: 5 months
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?
Foot pain
Time frame: 6 months
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?
Foot pain
Time frame: 7 months
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?
Foot pain
Time frame: 8 months
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?
Foot pain
Time frame: 9 months
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?
Foot pain
Time frame: 10 months
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?
Foot pain
Time frame: 11 months
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?
Foot pain
Time frame: 12 months
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?
Step counts
Time frame: Baseline
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.
Step counts
Time frame: 1 month
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.
Step counts
Time frame: 2 months
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.
Step counts
Time frame: 3 months
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.
Step counts
Time frame: 4 months
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.
Step counts
Time frame: 5 months
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.
Step counts
Time frame: 6 months
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.
Step counts
Time frame: 7 months
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.
Step counts
Time frame: 8 months
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.
Step counts
Time frame: 9 months
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.
Step counts
Time frame: 10 months
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.
Step counts
Time frame: 11 months
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.
Step counts
Time frame: 12 months
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.
Global Rating Outcome Change (GROC)
Time frame: 3 months
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?
Global Rating Outcome Change (GROC)
Time frame: 6 months
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?
Patient Acceptable Symptom State (PASS)
Time frame: 3 months
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?
Patient Acceptable Symptom State (PASS)
Time frame: 6 months
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?
12 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: 3 months
International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
Static and dynamic balance
Time frame: Baseline
Static and dynamic balance
Time frame: 3 months
Static and dynamic balance
Time frame: 6 months
Muscles size of cross sectional area
Time frame: Baseline
Muscles size of cross sectional area
Time frame: 3 months
Muscles size of cross sectional area
Time frame: 6 months
Muscle Strength
Time frame: Baseline
Muscle Strength
Time frame: 3 months
Muscle Strength
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing minimal shoes and foot strengthening and flexibility exercises and Supportive Footwear, foot orthotic device and foot flexibility exercises in people with Plantar Fasciitis, Chronic, run by University of South Florida 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Davis, PhD (3025596433, sdavis@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Health Status Questionnaire (FHSQ) (time frame: Baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.