Neuromuscular Study to Assess Foot Intrinsic Muscles | NCT03154853

Studies
Neuromuscular Study to Assess Foot Intrinsic Muscles

NCT03154853

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

May 23, 2017Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Flexible Flatfoot

Interventions

Behavioral: short foot exercise

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2016Actual

Primary Completion Date

Sep 30, 2017Estimated

Completion Date

Dec 30, 2017Estimated

First Submitted Date

May 8, 2017

First Submission Date that Met QC Criteria

May 15, 2017

First Posted Date

May 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2017

Last Update Posted Date

May 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal foot	No Intervention	no intervention
functional flatfoot	Experimental	Behavioral: short foot exercise	Other: Behavioral: short foot exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioral: short foot exercise	Other	Behavioral: short foot exercise 30 repetitions per section (10 seconds for each contraction, 1 minute between sections), 3 times/ week, 3 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jen Yu Chen, Ph.D.	Contact	+886-2-33668138		yujensch@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Jen Yu Chen	School and Graduate Institute of Physical Therapy of National Taiwan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		10018	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005413	Flatfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

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