Hallux Valgus and Custom Orthotic Prescription

NCT02386631 | Completed

• 1 other identifier: BC_HVFP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Hallux valgus can be defined as a progressive subluxation of the first metatarsophalangeal joint and lateral deviation of the hallux. This common foot condition is associated with altered gait patterns. Specifically reduced forward propulsion, leading to gait instability. Research has shown that foot problems and pain play a major role towards the contribution of falls in the adult population. There are currently two main interventions for the treatment of hallux valgus: surgery and orthotic prescription. There has not been a lot of research performed evaluating the effects of custom orthotic prescription on hallux valgus. Therefore, this study will investigate adults with moderate hallux valgus and the effects of orthotic intervention on the efficacy of forward propulsion during walking. It is hypothesized that implementation of an orthotic will lead to decreased foot pain, an increase in step length, an increase in the forward moment about the ankle and hallux, and a more medial center of pressure tracking through the great toe instead of the lesser metatarsals. This study will consist of 10 adults. The participant will go through three rounds of testing in the lab. The first session will consist of initial baseline testing in which each participant will be evaluated for severity of Hallux Valgus and range of motion of the first metatarsophalangeal joint. A foot casting will then be performed by a pedorthist and the participant will be set up with markers, so as to record motion while they perform 15 walking trials across a 10m runway with a force plate embedded in the middle whilst wearing standard footwear (no orthotic). The second lab session will consist of the standard footwear (no orthotic) walking as well as the addition of standard footwear with custom orthotic walking. The third session, after having worn the orthotic for two weeks, will repeat both conditions measured in the second lab session. Data about the center of pressure trajectories, step length, foot pain, and the moments about the ankle and first metatarsophalangeal joints will be collected and calculated.

Conditions

Hallux Valgus

Keywords

gait; orthotics; kinetics; hallux valgus; bunions

Outcome Measures

Primary Outcomes (1)

• Increased Propulsive moments (torques) as measured by inverse dynamics

  calculation of moments (torques) produced at the ankle and first metatarsophalangeal joint during push-off phase of the gait cycle

  measured at each visit (baseline, 1 week, 2 weeks), orthotic vs. no orthotic

Secondary Outcomes (1)

• Increased Gait Velocity

  measured at each visit (baseline, 1 week, 2 weeks), orthotic vs. no orthotic

Study Arms (1)

Orthotic

EXPERIMENTAL

Custom made orthotic provided for study

Device: Custom Made Orthotic

Interventions

Custom Made Orthotic DEVICE

Provides longitudinal arch support

Orthotic

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• moderate Hallux Valgus, as classified using the Manchester Scale
• good range of motion of the first metatarsophalangeal joint
• able to walk

You may not qualify if:

• no history or clinical evidence of any chronic disease and no history of lower extremity surgery
• medication that affect balance and stability

Sponsors & Collaborators

• Dr. Stephen Perry: lead

Study Sites (1)

WLU Biomechanics Laboratory

Waterloo, Ontario, N2L 3C5, Canada

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Study Officials

• Stephen D Perry, PhD

  Wilfrid Laurier University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 12, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

CA (1)