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Neuromuscular Study to Assess Foot Intrinsic Muscles

Primary Purpose

Flexible Flatfoot

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Behavioral: short foot exercise

About this trial

This is an interventional other trial for Flexible Flatfoot focused on measuring Electromyography,Excessive Foot Pronation,exercise,neurology,physical therapy

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

: Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

normal foot

functional flatfoot

Arm Description

no intervention

Behavioral: short foot exercise

Outcomes

Primary Outcome Measures

Muscle activities: EMGs (mV)

EMGs (mV) in each posture

Muscle activities: H-reflexes (mV)

H-reflexes (mV) in each posture

Muscle activities change will being assessed: EMGs (mV)

EMGs (mV) in each posture

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

H-reflexes (mV) in each posture

Secondary Outcome Measures

Full Information

NCT ID

NCT03154853

First Posted

May 8, 2017

Last Updated

May 21, 2017

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03154853

Brief Title

Neuromuscular Study to Assess Foot Intrinsic Muscles

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 4, 2016 (Actual)

Primary Completion Date

September 30, 2017 (Anticipated)

Study Completion Date

December 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flexible Flatfoot

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

normal foot

Arm Type

No Intervention

Arm Description

no intervention

Arm Title

functional flatfoot

Arm Type

Experimental

Arm Description

Behavioral: short foot exercise

Intervention Type

Other

Intervention Name(s)

Behavioral: short foot exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Muscle activities: EMGs (mV)

Description

EMGs (mV) in each posture

Time Frame

Baseline

Title

Muscle activities: H-reflexes (mV)

Description

H-reflexes (mV) in each posture

Time Frame

Baseline

Title

Muscle activities change will being assessed: EMGs (mV)

Description

EMGs (mV) in each posture

Time Frame

Baseline. week 3

Title

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

Description

H-reflexes (mV) in each posture

Time Frame

Baseline. week 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jen Yu Chen, Ph.D.

Phone

+886-2-33668138

yujensch@ntu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jen Yu Chen

Organizational Affiliation

School and Graduate Institute of Physical Therapy of National Taiwan University

Official's Role

Study Chair

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10018

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jen Yu Chen

Phone

0233668138

yujensch@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neuromuscular Study to Assess Foot Intrinsic Muscles

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