NCT03154853

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 8, 2017

Last Update Submit

May 21, 2017

Conditions

Keywords

Electromyography,Excessive Foot Pronation,exercise,neurology,physical therapy

Outcome Measures

Primary Outcomes (4)

  • Muscle activities: EMGs (mV)

    EMGs (mV) in each posture

    Baseline

  • Muscle activities: H-reflexes (mV)

    H-reflexes (mV) in each posture

    Baseline

  • Muscle activities change will being assessed: EMGs (mV)

    EMGs (mV) in each posture

    Baseline. week 3

  • Muscle activities change will being assessed: H-reflexes (mV)

    H-reflexes (mV) in each posture

    Baseline. week 3

Study Arms (2)

normal foot

NO INTERVENTION

no intervention

functional flatfoot

EXPERIMENTAL

Behavioral: short foot exercise

Other: Behavioral: short foot exercise

Interventions

Behavioral: short foot exercise 30 repetitions per section (10 seconds for each contraction, 1 minute between sections), 3 times/ week, 3 weeks

functional flatfoot

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 45 years
  • No ankle injury within the previous 6 months
  • No diagnosed lower extremity injuries
  • No ankle pain at the time of the study
  • Foot posture index score: 0 to +5 for the normal foot (NF) group; +6 to +12 for the functional flat foot (FFF) group
  • Navicular drop: 5-9 mm for the NF group; \> 10 mm for the FFF group

You may not qualify if:

  • Foot posture index score: \<0
  • Navicular drop\< 5 mm
  • Leg length discrepancy \> 1.5 cm
  • Diagnosed severe scoliosis
  • Neurological injuries over lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10018, Taiwan

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jen Yu Chen

    School and Graduate Institute of Physical Therapy of National Taiwan University

    STUDY CHAIR

Central Study Contacts

Jen Yu Chen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 16, 2017

Study Start

November 4, 2016

Primary Completion

September 30, 2017

Study Completion

December 30, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations