Foot Injuries and DisordersNCT04264611
Comparing the Effects of Foot Core Exercises
A study testing Experimental: Short Foot Exercise Group and Experimental: Towel Curl Exercise Group in people with Foot Injuries and Disorders and Balance; Distorted, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study was to compare the effects of towel curl exercises and short foot exercises on pedobarographic parameters and balance. 91 healthy students (63 females, 28 males) with mean age of 20,65±2,41 years who attend to Muğla Sıtkı Koçman University, Faculty of Health Sciences and met the inclusion… Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Injuries and Disorders, Balance; Distorted
- What is being tested?
- Experimental: Short Foot Exercise Group and Experimental: Towel Curl Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 28 Aug 2018
- Phase
- Interventional
- 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 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be over 18 years old
- Sign informed consent form
- Have not experienced towel curl exercise and short foot exercise
Who cannot join
- Any sign of foot pain
- The presence of problems affecting the foot such as diagnosed patellofemoral pain syndrome, plantar fasciitis, anterior or posterior tibialis dysfunction
- In the last 6 months; presence of injury or surgical operation of the lower extremity
- Lower limb length inequalities that affect gait
- The presence of a systemic, neurological, orthopedic disease or deformity that will affect motor function, balance and gait
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University
Ankara, Çankaya, 06510
About this study
Official title: Effects of Short Foot and Towel Curl Exercises on Foot Arches Morphology, Dynamic and Static Pedobarographic Parameters and Balance: Randomized Controlled Trial
The purpose of the study was to compare the effects of towel curl exercises and short foot exercises on pedobarographic parameters and balance. 91 healthy students (63 females, 28 males) with mean age of 20,65±2,41 years who attend to Muğla Sıtkı Koçman University, Faculty of Health Sciences and met the inclusion criteria and volunteered to participate included in this randomized controlled study. Participants were randomly divided into, Short Foot Exercise(n=28), Towel Curl Exercise (n=31) and Control Groups (n=32). Participant's demographic information were recorded, foot number measurement, navicular drop test, metatarsal width measurement, static and dynamic pedobarographic evaluations, and the balance evaluation were performed. Following the initial assessment, participants who included in Short Foot and Towel Curl Exercise Group performed the exercises that they were assigned to under the supervision of a physiotherapist for 4 weeks and no exercise was given to the control group. After the completion of 4 weeks all the initial assessments were repeated in all groups.
Read the detailed description
This study was planned as a randomized controlled study to compare the effects of Towel Curl Exercise (TCE) which is often used in physiotherapy clinics for injuries caused by contractile structures of the foot, especially in cases of pes planus and Short Foot Exercise (SFE) which has increasing popularity with recent studies. This study was conducted between March 2018 and June 2018. Firstly, informed consent form was signed by participants and that the rights of the subjects were protected. The participants were randomized using a computer assisted randomization method; they were divided into Short Foot Exercise Group (SFEG), Towel Curl Exercise Group (TCEG) and Control Group (CG). Pre and post-test design was used for this randomized controlled study. The dependent variables recorded before and after four weeks of SFE and TCE were; changes in navicular drop, metatarsal enlargement amounts, static and dynamic pedobarographic parameters and balance scores. Evaluations and exercises of the individuals were performed by the same researcher physiotherapist. The study protocol was approved by the ethics committee of Mugla Sıtkı Koçman University (Protocol no: 170054).
Subjects The study was conducted on 91 healthy subjects, 68 female and 23 male, with a mean age of 20.65 ± 2.410 years (18 to 34 years). Four of SFEG, three of TCEG, four of CG patients had left dominant feet and the others had right dominant feet.
Procedures Subjects were invited for evaluation in clinic for three consecutive days; first day their age, height, weight values, foot sizes, navicular drop distance (ND) and metatarsal width (MTW) were measured and determined their dominant lower extremity. Balance scores were recorded with SportKat device on the second day and static and dynamic pedobarography results recorded on the third day. Navicular drop test was used to evaluate the flexibility of the foot. In this study, MTW were measured in order to evaluate the effects of SFE and TCE on the flexibility of fore foot. Diagnostic Support Electronic Baropodometer and Milletrix software (DIASU®, Italy) were used for static and dynamic pedobarographic measurements to evaluate foot plantar pressure distribution.
After all evaluations had been completed the exercises were taught by the researcher physiotherapist with video and verbal narration and exercise were tested on each participant who were included Short Foot Exercise Group and Towel Curl Exercise Group.
Subjects who completed all evaluations, started their exercises according to the exercise groups they were assigned to and the CG was not given any exercise. Exercises were performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week. Exercises were progressed by sitting for one week, standing on double leg in the 2nd week and standing on one leg in the 3rd and 4th weeks in both groups. The individuals in the control group were asked not to go out of their daily physical activity routine during this four-week period.
The SFEG, TCEG and CG were called to the clinic again and their final measurements were recorded after the intervention.
- Conditions
- Foot Injuries and Disorders, Balance; Distorted
- Being tested
- Experimental: Short Foot Exercise Group, Experimental: Towel Curl Exercise Group
- Keywords
- Foot Core System, Plantar Intrinsic Foot Muscles, Short Foot Exercise, Towel Curl Exercise, Medial Longitudinal Arch, Pedobarography;, Balance
- Medical subject headings
- Foot Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Short Foot Exercise GroupOther
Short foot exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week.
Experimental: Towel Curl Exercise GroupOther
Towel curl exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week.
| Study group | Role | What they receive |
|---|---|---|
| Short Foot Exercise Group | Experimental | The group that received the short foot exercise Receives: Other: Experimental: Short Foot Exercise Group |
| Towel Curl Exercise Group | Experimental | The group that received the towel curl exercise Receives: Other: Experimental: Towel Curl Exercise Group |
| Control Group | No intervention | The group that received no exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring navicular drop distance
The individual was placed on a stool with the bare foot, hip, knee and ankle flexed 90 degrees with the foot in full contact with the floor and was asked to look at a fixed point opposite. In this position the navicular tubercle was determined with the erasable pen and the navicular height above the ground was marked on an index card. Then, the individual was asked to stand up without changing the position of her/his heels and while standing, the navicular tubercle was again determined and its height above the ground was marked on the index card. The distance between the navicular heights marked on the index card in the sitting and standing positions was measured with the help of the INSIZE® 1108-200 digital caliper and recorded as navicular drop distance in mm.
Measured: 3 minutes
Measuring metatarsal width
Metatarsal width was recorded by measuring the extreme distance between the medial soft tissue line at the first metatarsal head level and the lateral soft tissue line at the fifth metatarsal head level. It was measured using the INSIZE® 1108-200 digital caliper for both feet while giving equal weight to both lower extremities in the sitting position at 90 degrees flexion of the hip, knee and ankle joints and giving equal weight to both lower extremities in the standing position. Metatarsal width in sitting and standing positions were recorded and the difference between them was calculated and recorded as the amount of metatarsal enlargement in mm.
Measured: 3 minutes
Pedobarographic evaluation
Diagnostic Support Electronic Baropodometer and Milletrix software (DIASU®, Italy) were used for static and dynamic pedobarographic measurements to evaluate foot plantar pressure distrubution. Static measurements were made with the patient standing on a platform with pressure sensor, with two bare feet, in a loose standing position, looking at a fixed point opposite. The dynamic measurements were made after the individuals performed a trial walk on the platform once. Individuals were asked to walk self- selected speed and pattern. The average values of 4 dynamic measurements were taken for both foot and the results were recorded.
Measured: 10 minutes
Balance evaluation
Static and dynamic balances of individuals on double and single legs were evaluated using SportKAT® Model 650-TS, LLC, USA. The monitor was positioned 130 cm forward and at the eye level of the subject. Individuals standing on the platform whose pressure was set to 6 PSI and they were asked to position their arms across the shoulders. The test was canceled and repeated in the event that individuals arms were distorted or they fall off the platform.
Measured: 10 minutes
Secondary outcomes (1)
Foot size
Foot size was measured using ruler which is proper for Turkey and European standarts.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Injuries and DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Collaborators
- Muğla Sıtkı Koçman University
- Responsible party
- Principal investigator, MERVE SEVİK, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264611
- Sponsor's protocol ID
- 170054
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Foot and Towel Curl Exercises on Foot Arches Morphology, Dynamic and Static Pedobarographic Parameters and Balance: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04264611
- Acronym / sponsor ID
- 170054
- Conditions
- Foot Injuries and Disorders, Balance; Distorted
- Keywords
- Foot Core System, Plantar Intrinsic Foot Muscles, Short Foot Exercise, Towel Curl Exercise, Medial Longitudinal Arch, Pedobarography;, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Collaborators
- Muğla Sıtkı Koçman University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 11 Feb 2020 (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 purpose of the study was to compare the effects of towel curl exercises and short foot exercises on pedobarographic parameters and balance. 91 healthy students (63 females, 28 males) with mean age of 20,65±2,41 years who attend to Muğla Sıtkı Koçman University, Faculty of Health Sciences and met the inclusion criteria and volunteered to participate included in this randomized controlled study. Participants were randomly divided into, Short Foot Exercise(n=28), Towel Curl Exercise (n=31) and Control Groups (n=32). Participant's demographic information were recorded, foot number measurement, navicular drop test, metatarsal width measurement, static and dynamic pedobarographic evaluations, and the balance evaluation were performed. Following the initial assessment, participants who included in Short Foot and Towel Curl Exercise Group performed the exercises that they were assigned to under the supervision of a physiotherapist for 4 weeks and no exercise was given to the control group. After the completion of 4 weeks all the initial assessments were repeated in all groups.
Detailed description
This study was planned as a randomized controlled study to compare the effects of Towel Curl Exercise (TCE) which is often used in physiotherapy clinics for injuries caused by contractile structures of the foot, especially in cases of pes planus and Short Foot Exercise (SFE) which has increasing popularity with recent studies. This study was conducted between March 2018 and June 2018. Firstly, informed consent form was signed by participants and that the rights of the subjects were protected. The participants were randomized using a computer assisted randomization method; they were divided into Short Foot Exercise Group (SFEG), Towel Curl Exercise Group (TCEG) and Control Group (CG). Pre and post-test design was used for this randomized controlled study. The dependent variables recorded before and after four weeks of SFE and TCE were; changes in navicular drop, metatarsal enlargement amounts, static and dynamic pedobarographic parameters and balance scores. Evaluations and exercises of the individuals were performed by the same researcher physiotherapist. The study protocol was approved by the ethics committee of Mugla Sıtkı Koçman University (Protocol no: 170054).
Subjects The study was conducted on 91 healthy subjects, 68 female and 23 male, with a mean age of 20.65 ± 2.410 years (18 to 34 years). Four of SFEG, three of TCEG, four of CG patients had left dominant feet and the others had right dominant feet.
Procedures Subjects were invited for evaluation in clinic for three consecutive days; first day their age, height, weight values, foot sizes, navicular drop distance (ND) and metatarsal width (MTW) were measured and determined their dominant lower extremity. Balance scores were recorded with SportKat device on the second day and static and dynamic pedobarography results recorded on the third day. Navicular drop test was used to evaluate the flexibility of the foot. In this study, MTW were measured in order to evaluate the effects of SFE and TCE on the flexibility of fore foot. Diagnostic Support Electronic Baropodometer and Milletrix software (DIASU®, Italy) were used for static and dynamic pedobarographic measurements to evaluate foot plantar pressure distribution.
After all evaluations had been completed the exercises were taught by the researcher physiotherapist with video and verbal narration and exercise were tested on each participant who were included Short Foot Exercise Group and Towel Curl Exercise Group.
Subjects who completed all evaluations, started their exercises according to the exercise groups they were assigned to and the CG was not given any exercise. Exercises were performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week. Exercises were progressed by sitting for one week, standing on double leg in the 2nd week and standing on one leg in the 3rd and 4th weeks in both groups. The individuals in the control group were asked not to go out of their daily physical activity routine during this four-week period.
The SFEG, TCEG and CG were called to the clinic again and their final measurements were recorded after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short Foot Exercise Group | Experimental | Other: Experimental: Short Foot Exercise GroupThe group that received the short foot exercise |
| Towel Curl Exercise Group | Experimental | Other: Experimental: Towel Curl Exercise GroupThe group that received the towel curl exercise |
| Control Group | No intervention | –The group that received no exercise |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be over 18 years old
- Sign informed consent form
- Have not experienced towel curl exercise and short foot exercise
Key exclusion criteria (5 listed)
- Any sign of foot pain
- The presence of problems affecting the foot such as diagnosed patellofemoral pain syndrome, plantar fasciitis, anterior or posterior tibialis dysfunction
- In the last 6 months; presence of injury or surgical operation of the lower extremity
- Lower limb length inequalities that affect gait
- The presence of a systemic, neurological, orthopedic disease or deformity that will affect motor function, balance and gait
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 |
|---|---|---|
| Experimental: Short Foot Exercise GroupShort foot exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week. | Other | Short Foot Exercise Group |
| Experimental: Towel Curl Exercise GroupTowel curl exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week. | Other | Towel Curl Exercise Group |
Primary outcome
Measuring navicular drop distance
Time frame: 3 minutes
The individual was placed on a stool with the bare foot, hip, knee and ankle flexed 90 degrees with the foot in full contact with the floor and was asked to look at a fixed point opposite. In this position the navicular tubercle was determined with the erasable pen and the navicular height above the ground was marked on an index card. Then, the individual was asked to stand up without changing the position of her/his heels and while standing, the navicular tubercle was again determined and its height above the ground was marked on the index card. The distance between the navicular heights marked on the index card in the sitting and standing positions was measured with the help of the INSIZE® 1108-200 digital caliper and recorded as navicular drop distance in mm.
Measuring metatarsal width
Time frame: 3 minutes
Metatarsal width was recorded by measuring the extreme distance between the medial soft tissue line at the first metatarsal head level and the lateral soft tissue line at the fifth metatarsal head level. It was measured using the INSIZE® 1108-200 digital caliper for both feet while giving equal weight to both lower extremities in the sitting position at 90 degrees flexion of the hip, knee and ankle joints and giving equal weight to both lower extremities in the standing position. Metatarsal width in sitting and standing positions were recorded and the difference between them was calculated and recorded as the amount of metatarsal enlargement in mm.
Pedobarographic evaluation
Time frame: 10 minutes
Diagnostic Support Electronic Baropodometer and Milletrix software (DIASU®, Italy) were used for static and dynamic pedobarographic measurements to evaluate foot plantar pressure distrubution. Static measurements were made with the patient standing on a platform with pressure sensor, with two bare feet, in a loose standing position, looking at a fixed point opposite. The dynamic measurements were made after the individuals performed a trial walk on the platform once. Individuals were asked to walk self- selected speed and pattern. The average values of 4 dynamic measurements were taken for both foot and the results were recorded.
Balance evaluation
Time frame: 10 minutes
Static and dynamic balances of individuals on double and single legs were evaluated using SportKAT® Model 650-TS, LLC, USA. The monitor was positioned 130 cm forward and at the eye level of the subject. Individuals standing on the platform whose pressure was set to 6 PSI and they were asked to position their arms across the shoulders. The test was canceled and repeated in the event that individuals arms were distorted or they fall off the platform.
1 secondary outcome
Foot size
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Short Foot Exercise Group and Experimental: Towel Curl Exercise Group in people with Foot Injuries and Disorders and Balance; Distorted, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 11 Feb 2020. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring navicular drop distance (time frame: 3 minutes). The study lists 4 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 11 Feb 2020.