The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination

NCT02957812 | Completed

• 1 other identifier: 5114
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the long-term effects that orthotics imposes on the structure and function of the foot. The objectives of the study are to determine if the use of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar intrinsic muscles and (c) creates any changes in balance control during gait termination. The aim of the study is to enhance the appropriate dispensing of orthotics, and whether additional measures, such as rehabilitation exercises are necessary to increase their overall effectiveness in the clinical setting.

Conditions

Flatfoot

Keywords

Gait; Balance Control; Orthotics

Outcome Measures

Primary Outcomes (3)

• Change in Cross-sectional area (CSA) of intrinsic foot muscles

  the area of the cross section of a muscle perpendicular to its fibers

  Baseline, 6 weeks, and 12 weeks post baseline

• change in muscle activity and timing of Electromyography (EMG)

  muscle activity and muscle timing

  Baseline, 6 weeks, and 12 weeks

• change in Balance stability margin

  how close their body gets to perimeter of their base of support

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (4)

• Range of motion (ROM)

  Baseline and 12 weeks

• Stride Length

  Baseline and 12 weeks

• Stride Width

  Baseline and 12 weeks

• Gait Velocity

  Baseline and 12 weeks

Study Arms (2)

Orthotics

EXPERIMENTAL

Custom made orthotic provided for study

Device: Custom-made Foot Orthotics (CFO)

Control

NO INTERVENTION

Wearing own footwear

Interventions

Custom-made Foot Orthotics (CFO) DEVICE

Provides longitudinal arch support

Orthotics

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a score of (+5) on the Foot Posture Index (FPI)
• navicular height \< 3.6cm
• able to walk

You may not qualify if:

• have worn CFOs in the past year,
• current lower limb injury, leg or foot pain
• neurological or musculoskeletal disorders affecting the function of the foot
• previous history of lower limb surgery
• protein intake above the recommended daily allowance (RDA)
• medications that effect balance.

Sponsors & Collaborators

• Wilfrid Laurier University: lead

Study Sites (1)

Biomechanics Lab

Waterloo, Ontario, N2L 3C5, Canada

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: July 21, 2017
• Study Completion: August 31, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

CA (1)