Recruiting

Foot Muscle Strengthening

Sponsor:

Springfield College

Code:

NCT05829369

Conditions

Accidental Fall

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Intrinsic foot muscle strengthening exercises

Minimal footwear with prescribed walking

Control

Study Details

Brief summary:

Falls are the leading cause of injury in adults over age 65. Muscle weakness in the foot can lead to foot and toe deformities such as collapsed arches or bunions, which have been found to contribute to falls in adults over age 65. The current research study aims to investigate the effectiveness of two simple and affordable foot strengthening methods that may make a major impact on balance and fall prevention in older adults.

Conditions

Accidental Fall

Study ID

NCT05829369

Start date

Dec 16, 2022

Status verified date

Apr, 2023

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Can ambulate household distances (16 meters) with or without an assistive device
  • Have fall risk based on a "yes" to any of the Three Key Questions Do you feel unsteady when standing or walking? Do you worry about falling? Have you fallen in the past year? OR
  • Have a fall risk based on Timed Up and Go score (> 12 seconds)

Exclusion Criteria:

  • poor foot sensation (Semmes-Weinstein)
  • lower extremity amputations
  • lumbar spine or lower extremity injury or surgery in the past 6 months
  • impaired cognitive ability to follow verbal or written instructions (MMSE)
  • vestibular disorders
  • based on self-report and/or the Vestibular Screening Tool (score > 4)
  • participation in a fall prevention program in the previous 6 months

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intrinsic foot muscle exercise

This group will perform intrinsic foot muscle strengthening exercises

active comparator: Minimal Footwear

This group will perform prescribed walking in and daily wear of minimally cushioned footwear

sham comparator: Control

This group will be given a falls prevention brochure and seated upper extremity and lower extremity active range of motion activities.

Interventions

Intrinsic foot muscle strengthening exercises

participants will perform specific toe and foot motions that recruit plantar intrinsic foot muscles, 3 sets of 10 for each exercise, 5 days per week

Minimal footwear with prescribed walking

Participants will be provided minimal footwear. They will walk 30 minutes per day, 5 days per week, and be prescribed a gradual increased time in minimal footwear during daily activities (up to a maximum of 7.5 hours per day).

Control

Participants will perform seated upper and lower extremity active range of motion activities 5 days per week. They will also be given a brochure on fall prevention tips.

Primary outcome measure

  • Change in Mini BesTest scores [ Time Frame: Baseline ]
  • Change in Mini BesTest scores [ Time Frame: 8 weeks post intervention ]
  • Change in Mini BesTest scores [ Time Frame: 16 weeks post intervention ]
  • Change in Mini BesTest scores [ Time Frame: 1 year post intervention ]
  • Change in intrinsic foot muscle cross-sectional area/strength [ Time Frame: Baseline ]
  • Change in intrinsic foot muscle cross-sectional area/strength [ Time Frame: 8 weeks post intervention ]
  • Change in intrinsic foot muscle cross-sectional area/strength [ Time Frame: 16 weeks post intervention ]
  • Change in intrinsic foot muscle cross-sectional area/strength [ Time Frame: 1 year post intervention ]

Central Contacts and Locations

Central contacts

Erin Futrell, PhD

413-748-3590efutrell@springfieldcollege.edu

Regina Kaufman, EdD

413-748-3475rkaufman@springfieldcollege.edu

Locations

Springfield College

Recruiting

Springfield, Massachusetts, United States, 01027

Contacts

Erin Futrell

413-748-3590efutrell@springfieldcollege.edu

More Information

Sponsor

Springfield College

Last update posted

Apr 25, 2023

Last verified

Apr, 2023

Keywords

  • older adults
  • falls
  • feet
  • balance
  • proprioception
  • muscle strength

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Springfield College on 2023-04-25.