Flexible FlatfootNCT03154853
Neuromuscular Study to Assess Foot Intrinsic Muscles
A study testing Behavioral: short foot exercise in people with Flexible Flatfoot, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purposes of these studies are to investigate: Differences in abductor hallucis muscles'EMG activities during different postural tasks between individuals with normal foot alignment and functional flat foot. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- Behavioral: short foot exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Nov 2016to 30 Dec 2017
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Foot posture index score: <0
- Navicular drop< 5 mm
- Leg length discrepancy > 1.5 cm
- Diagnosed severe scoliosis
- Neurological injuries over lower extremities
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10018
Jen Yu Chen, 0233668138, yujensch@ntu.edu.tw
About this study
Official title: Neuromuscular Assessments of Foot Intrinsic Muscles: (1) Between Individuals With and Without Functional Flatfoot and (2) Before and After a 3-week Short Foot Exercise Training in Individuals With Functional Flatfoot
The purposes of these studies are to investigate:
Differences in abductor hallucis muscles'EMG activities during different postural tasks between individuals with normal foot alignment and functional flat foot. Differences in abductor hallucis muscles'H-reflex amplitudes between individuals with normal foot alignment and functional flat foot. Changes in abductor hallucis muscles'EMG activities during different postural tasks after a 3-week short foot exercises training regimen in individuals with functional flat foot. Changes in abductor hallucis muscles'H-reflex amplitudes after a 3-week short foot exercises training regimen in individuals with functional flat foot. hypotheses: Peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. H-reflex amplitudes of abductor hallucis muscles were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. Changes of peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen. Changes of H-reflex amplitudes of abductor hallucis muscles were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen
- Conditions
- Flexible Flatfoot
- Being tested
- Behavioral: short foot exercise
- Keywords
- Electromyography,Excessive Foot Pronation,exercise,neurology,physical therapy
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: short foot exerciseOther
Behavioral: short foot exercise 30 repetitions per section (10 seconds for each contraction, 1 minute between sections), 3 times/ week, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| normal foot | No intervention | no intervention |
| functional flatfoot | Experimental | Behavioral: short foot exercise Receives: Other: Behavioral: short foot exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activities: EMGs (mV)
EMGs (mV) in each posture
Measured: Baseline
Muscle activities: H-reflexes (mV)
H-reflexes (mV) in each posture
Measured: Baseline
Muscle activities change will being assessed: EMGs (mV)
EMGs (mV) in each posture
Measured: Baseline. week 3
Muscle activities change will being assessed: H-reflexes (mV)
H-reflexes (mV) in each posture
Measured: Baseline. week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start4 Nov 2016
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen Yu Chen, Study chair, School and Graduate Institute of Physical Therapy of National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154853
- Sponsor's protocol ID
- 201607074RINB
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Assessments of Foot Intrinsic Muscles: (1) Between Individuals With and Without Functional Flatfoot and (2) Before and After a 3-week Short Foot Exercise Training in Individuals With Functional Flatfoot
- ClinicalTrials.gov ID
- NCT03154853
- Acronym / sponsor ID
- 201607074RINB
- Conditions
- Flexible Flatfoot
- Keywords
- Electromyography,Excessive Foot Pronation,exercise,neurology,physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 16 May 2017 (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 purposes of these studies are to investigate:
Differences in abductor hallucis muscles'EMG activities during different postural tasks between individuals with normal foot alignment and functional flat foot. Differences in abductor hallucis muscles'H-reflex amplitudes between individuals with normal foot alignment and functional flat foot. Changes in abductor hallucis muscles'EMG activities during different postural tasks after a 3-week short foot exercises training regimen in individuals with functional flat foot. Changes in abductor hallucis muscles'H-reflex amplitudes after a 3-week short foot exercises training regimen in individuals with functional flat foot. hypotheses: Peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. H-reflex amplitudes of abductor hallucis muscles were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. Changes of peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen. Changes of H-reflex amplitudes of abductor hallucis muscles were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal foot | No intervention | –no intervention |
| functional flatfoot | Experimental | Other: Behavioral: short foot exerciseBehavioral: short foot exercise |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Foot posture index score: <0
- Navicular drop< 5 mm
- Leg length discrepancy > 1.5 cm
- Diagnosed severe scoliosis
- Neurological injuries over lower extremities
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 |
|---|---|---|
| Behavioral: short foot exerciseBehavioral: short foot exercise 30 repetitions per section (10 seconds for each contraction, 1 minute between sections), 3 times/ week, 3 weeks | Other | functional flatfoot |
Primary outcome
Muscle activities: EMGs (mV)
Time frame: Baseline
EMGs (mV) in each posture
Muscle activities: H-reflexes (mV)
Time frame: Baseline
H-reflexes (mV) in each posture
Muscle activities change will being assessed: EMGs (mV)
Time frame: Baseline. week 3
EMGs (mV) in each posture
Muscle activities change will being assessed: H-reflexes (mV)
Time frame: Baseline. week 3
H-reflexes (mV) in each posture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
Related trials for Flexible Flatfoot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
Pediatric Flexible Flatfoot
Not yet recruiting
Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
Patellofemoral Joint, Flatfoot
Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Flexible Flatfoot or Pes Planus
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.
Jen Yu Chen study chair
School and Graduate Institute of Physical Therapy of National Taiwan 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 Behavioral: short foot exercise in people with Flexible Flatfoot, run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 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 23 May 2017. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jen Yu Chen, Ph.D. (+886-2-33668138, yujensch@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activities: EMGs (mV) (time frame: Baseline). 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 23 May 2017.