Intrinsic Foot Muscle Strengthening Interventions for Older Adults

NCT05829369 | Unknown

• 1 other identifier: U01CE003495
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Change in Mini BesTest scores

  a comprehensive measure of balance, gait, and functional mobility (max score 28 and indicates good balance/mobility and low fall risk)

  Baseline

• Change in Mini BesTest scores

  a comprehensive measure of balance, gait, and functional mobility (max score 28 and indicates good balance/mobility and low fall risk)

  8 weeks post intervention

• Change in Mini BesTest scores

  a comprehensive measure of balance, gait, and functional mobility (max score 28 and indicates good balance/mobility and low fall risk)

  16 weeks post intervention

• Change in Mini BesTest scores

  a comprehensive measure of balance, gait, and functional mobility (max score 28 and indicates good balance/mobility and low fall risk)

  1 year post intervention

• Change in intrinsic foot muscle cross-sectional area/strength

  real-time ultrasound imaging will measure muscle size (cross-sectional area) of the abductor hallucis, flexor hallucis brevis, flexor digitorum brevis, quadratus plantae, and abductor digiti minimi muscles of the right foot

  Baseline

• Change in intrinsic foot muscle cross-sectional area/strength

  real-time ultrasound imaging will measure muscle size (cross-sectional area) of the abductor hallucis, flexor hallucis brevis, flexor digitorum brevis, quadratus plantae, and abductor digiti minimi muscles of the right foot

  8 weeks post intervention

• Change in intrinsic foot muscle cross-sectional area/strength

  real-time ultrasound imaging will measure muscle size (cross-sectional area) of the abductor hallucis, flexor hallucis brevis, flexor digitorum brevis, quadratus plantae, and abductor digiti minimi muscles of the right foot

  16 weeks post intervention

• Change in intrinsic foot muscle cross-sectional area/strength

  real-time ultrasound imaging will measure muscle size (cross-sectional area) of the abductor hallucis, flexor hallucis brevis, flexor digitorum brevis, quadratus plantae, and abductor digiti minimi muscles of the right foot

  1 year post intervention

Secondary Outcomes (12)

• Change in hallux valgus angle

  Baseline

• Change in hallux valgus angle

  8 weeks post intervention

• Change in hallux valgus angle

  16 weeks post intervention

• Change in hallux valgus angle

  1 year post intervention

• Change in navicular drop measure

  Baseline

Study Arms (3)

Intrinsic foot muscle exercise

EXPERIMENTAL

This group will perform intrinsic foot muscle strengthening exercises

Other: Intrinsic foot muscle strengthening exercises

Minimal Footwear

ACTIVE COMPARATOR

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

Other: Minimal footwear with prescribed walking

Control

SHAM COMPARATOR

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

Other: Control

Interventions

Intrinsic foot muscle strengthening exercises OTHER

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

Intrinsic foot muscle exercise

Minimal footwear with prescribed walking OTHER

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).

Minimal Footwear

Control OTHER

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Springfield College: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Springfield College

Springfield, Massachusetts, 01027, United States

RECRUITING

Study Officials

• Erin Futrell, PhD

  Springfield College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Futrell, PhD

CONTACT

413-748-3590; efutrell@springfieldcollege.edu

Regina Kaufman, EdD

CONTACT

413-748-3475; rkaufman@springfieldcollege.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are unable to be blinded to treatment they are receiving, but they will not be told interventions of other groups. Investigators who perform measurements are blinded to intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial with an effectiveness-implementation hybrid design Type I

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: April 25, 2023
• Study Start: December 16, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)