Muscle FatigueNCT04415099
Tibialis Posterior Fatigue and Plantar Pressure
A study testing Muscle fatigue protocol in people with Muscle Fatigue, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Muscle fatigue protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 15 Jul 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants were currently free from congenital or traumatic deformity to either lower extremity,
- A history of foot pain,
- Prior history of surgery to the foot and lower extremity
- A traumatic injury to the ankle or foot 12 months prior to the start of data collection.
Who cannot join
- Participants were excluded from this study if they had any orthopedic or neurological disorder, need to use an assistive device or orthoses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics
The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale.
Read the detailed description
The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to determine the normality. The student's t-test for paired samples were used to analyse, means (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's d-effect size were calculated. The significance level was set at .05. The effect size was considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.
- Conditions
- Muscle Fatigue
- Being tested
- Muscle fatigue protocol
- Keywords
- Plantar pressure distribution, muscle fatigue, tibialis posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle fatigue protocolOther
Tibialis posterior was fatigued using 2 exercises:
- Unilateral heel raise exercise
- Close chain resisted foot adduction exercise
| Study group | Role | What they receive |
|---|---|---|
| One group | Experimental | Only one group was assessed before and after performing muscle fatigue protocol. Receives: Other: Muscle fatigue protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plantar Pressures of the foot
The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
Measured: 1 month
Secondary outcomes (4)
Contact area of the foot
The percentage of the contact area (CA%) of forefoot (FF), midfoot (MF) and hindfoot (HF) was recorded. The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
Measured: 1 month
Foot axis angle
Foot axis angle (FAA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
Measured: 1 month
Subtalar angle
Minimum and maximum value of the subtalar angle (STA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
Measured: 1 month
Static plantar pressure
The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kısacık, PhD, Hacettepe University
- Investigators
- Nilgün Bek, Prof.Dr., Study director, Lokman Hekim UniversityAzize Reda Caferoglu Tunç, MSc, Principal investigator, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415099
- Sponsor's protocol ID
- LUT 12/46-16
- Status last verified
- May 2020
- First submitted
- 14 Apr 2020
- Last updated
- 20 Jul 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 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics
- ClinicalTrials.gov ID
- NCT04415099
- Acronym / sponsor ID
- LUT 12/46-16
- Conditions
- Muscle Fatigue
- Keywords
- Plantar pressure distribution, muscle fatigue, tibialis posterior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 4 Jun 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 this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale.
Detailed description
The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to determine the normality. The student's t-test for paired samples were used to analyse, means (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's d-effect size were calculated. The significance level was set at .05. The effect size was considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | Experimental | Other: Muscle fatigue protocolOnly one group was assessed before and after performing muscle fatigue protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All participants were currently free from congenital or traumatic deformity to either lower extremity,
- A history of foot pain,
- Prior history of surgery to the foot and lower extremity
- A traumatic injury to the ankle or foot 12 months prior to the start of data collection.
Key exclusion criteria (1 listed)
- Participants were excluded from this study if they had any orthopedic or neurological disorder, need to use an assistive device or orthoses.
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 |
|---|---|---|
| Muscle fatigue protocolTibialis posterior was fatigued using 2 exercises: 1. Unilateral heel raise exercise 2. Close chain resisted foot adduction exercise | Other | One group |
Primary outcome
Peak Plantar Pressures of the foot
Time frame: 1 month
The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
4 secondary outcomes
Contact area of the foot
Time frame: 1 month
Foot axis angle
Time frame: 1 month
Subtalar angle
Time frame: 1 month
Static plantar pressure
Time frame: 1 month
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 20 Jul 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.
Nilgün Bek, Prof.Dr. study director
Lokman Hekim University
Azize Reda Caferoglu Tunç, MSc principal investigator
Lokman Hekim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle fatigue protocol in people with Muscle Fatigue, run by Hacettepe 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 4 inclusion and 1 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 20 Jul 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?
Peak Plantar Pressures of the foot (time frame: 1 month). 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 20 Jul 2020.