Neuromuscular Study to Assess Foot Intrinsic Muscles

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

Study Overview

• Status: Unknown
• Conditions: Flexible Flatfoot
• Intervention / Treatment: Other: Behavioral: short foot exercise

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jen Yu Chen, Ph.D.; Phone Number: +886-2-33668138; Email: yujensch@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10018
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Jen Yu Chen; Phone Number: 0233668138; Email: yujensch@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

: 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: normal foot; no intervention
Experimental: functional flatfoot; Behavioral: short foot exercise	Other: Behavioral: short foot exercise; Behavioral: short foot exercise 30 repetitions per section (10 seconds for each contraction, 1 minute between sections), 3 times/ week, 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Jen Yu Chen, School and Graduate Institute of Physical Therapy of National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2016
• Primary Completion (Anticipated): September 30, 2017
• Study Completion (Anticipated): December 30, 2017

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 21, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Electromyography,Excessive Foot Pronation,exercise,neurology,physical therapy
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: 201607074RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No