Training Intrinsic Foot Muscles

NCT ID: NCT03670563

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-04-05

Brief Summary

The foot intrinsic muscles are increasingly targeted in foot and ankle rehabilitation. The exercises are often difficult to learn initially. The purpose of the proposed study is to examine the effect training the intrinsic foot muscles on performance in selected physical and functional measures such as balance, plantar pressure during gait, vertical jump, and foot posture. In addition,the investigators will compare one group training with traditional exercise instruction methods and one group using an adjunctive modality (neuromuscular electric stimulation) during the introductory phases of exercise instruction. The investigators are interested in how this modality might affect physical and functional outcome measures and if it affects participants' frustration with learning a new exercise.

Detailed Description

Arm 1: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with passive, active-assisted, and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. A frustration index will be employed to assess participant frustration with learning a new exercise. 15 will be enrolled in this arm of the study.

Arm 2: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with neuromuscular electric stimulation (NMES) and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. A frustration index will be employed to assess participant frustration with learning a new exercise.15 will be enrolled in this arm of the study.

Arm 3: This group will not engage in any training, but will serve as a comparator for the two intervention arms.

Conditions

Muscular Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise 1

Short foot exercise protocol instructed utilizing verbal instruction, passive modeling, active-assisted modeling, and active modeling.

Group Type: EXPERIMENTAL

Short foot exercise protocol

Intervention Type: OTHER

Exercises that target intrinsic foot muscles

Exercise 2

Short foot exercises plus NMES. Short foot exercise protocol instructed utilizing verbal instruction, passive modeling assisted by neuromuscular electric stimulation (NMES), active-assisted modeling assisted by neuromuscular electric stimulation, and active modeling.

Group Type: ACTIVE_COMPARATOR

Short foot exercise plus NMES

Intervention Type: OTHER

Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education

Control

No exercise intervention; continue normal physical activity, but do not start any new exercise programs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Short foot exercise protocol

Exercises that target intrinsic foot muscles

Intervention Type: OTHER

Short foot exercise plus NMES

Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals aged 18-30; Participate in physical activity 3 times/week; No neurologic injury/condition; No prior experience with study exercises; No injury to lower extremity in past 2 months; Inability to selectively extend the great toe while the lesser toes remain quiet (indicating INTRINSIC FOOT MUSCLES dysfunction)

Exclusion Criteria

• Sedentary; Known neurologic injury or condition; Current LE injury that may affect neuromuscular function; Tarsal coalition; Absolute contradiction to manual therapy or neuromuscular electrical stimulation (NMES); Previous intrinsic foot muscle training protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Katherine Newsham PhD, ATC

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Newsham, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

IRB# 29267

Identifier Type: -

Identifier Source: org_study_id