Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics

NCT04830540 | Unknown

• 1 other identifier: 1826
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to understand the impact of wearing shoes with a compliant, energy absorbing midsole material, outside of athletic training sessions on the mechanics of movement, performance, and perceived joint pain and stiffness. Advances in material science have led to a wider range of cushioning system material properties and mid and outsole geometries in footwear. While there are many marketing claims about the potential health benefits of this new class of footwear these have not yet been investigated in well-designed scientific studies. It is hypothesized that the intervention shoe as compared to the control will reduce self-reported joint pain and stiffness, improve ankle plantarflexion function and increase intersegmental foot motion during walking.

Conditions

Arthralgia; Joint Stiffness; Gait Mechanics

Outcome Measures

Primary Outcomes (16)

• Calf Muscles Strength

  Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.

  2 - 3 hours on week 1

• Calf Muscles Strength

  Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.

  2 - 3 hours on week 6.

• Gait Mechanics

  Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.

  Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s

• Gait Mechanics

  Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.

  Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s

• Muscle EMG activity

  Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.

  Gait analysis test at week 1 with 5 trials of overground walking at a speed of 1.4 m/s

• Muscle EMG activity

  Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.

  Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s

• Maximum Vertical Jump

  Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.

  2 - 3 hours on week 1

• Maximum Vertical Jump

  Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.

  2 - 3 hours on week 6

• Self-reported shoe comfort

  Shoe wear and comfort log

  Week 0, 5 minutes

• Self-reported pain, and injury.

  Injury and pain log

  Week 0, 5 minutes

• Self-reported shoe comfort

  Shoe wear and comfort log

  Week 2, 5 minutes

• Self-reported pain, and injury.

  Injury and pain log

  Week 2, 5 minutes

• Self-reported shoe comfort

  Shoe wear and comfort log

  Week 4, 5 minutes

• Self-reported pain, and injury.

  Injury and pain log

  Week 4, 5 minutes

• Self-reported shoe comfort

  Shoe wear and comfort log

  Week 6, 5 minutes

• Self-reported pain, and injury.

  Injury and pain log

  Week 6, 5 minutes

Study Arms (2)

Control

NO INTERVENTION

Participants assigned to the control group will be asked to continue wearing their typical shoes and to complete every two weeks the footwear and injury log provided

Intervention

EXPERIMENTAL

Individuals assigned to the intervention group will be provided with 2 styles of the OOFOS recovery shoes, and will be asked to wear the OOFOS slide, sandal and/or closed toe shoes as their primary footwear outside training and competition for the 6 weeks between study visits. Intervention participants will also be asked to complete a daily shoe wear log and a shoe comfort assessment survey every other week.

Device: OOFOS Recovery Footwear

Interventions

OOFOS Recovery Footwear DEVICE

The OOFOS shoes/ sandals are a commercially available footwear with a compliant, energy absorbing midsole material.

Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18 - 35 kg/m2.
• Stiff or cleated footwear athlete on a competitive team.

You may not qualify if:

• Current injury that required absence from one or more practices in the last 3 weeks of regular team practice.
• Orthotic or other shoe insert used outside of athletic training times.

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

Musculoskeletal & Orthopedic Biomechanics Laboratory/ University of Massachusetts Amherst

Amherst, Massachusetts, 01002, United States

RECRUITING

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: April 5, 2021
• Study Start: February 8, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)