Training Intrinsic Foot Muscles

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.

Study Overview

• Status: Completed
• Conditions: Muscular Weakness
• Intervention / Treatment: Other: Short foot exercise protocol; Other: Short foot exercise plus NMES

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise 1; Short foot exercise protocol instructed utilizing verbal instruction, passive modeling, active-assisted modeling, and active modeling.	Other: Short foot exercise protocol; Exercises that target intrinsic foot muscles
Active Comparator: 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.	Other: Short foot exercise plus NMES; Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education
No Intervention: Control; No exercise intervention; continue normal physical activity, but do not start any new exercise programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaching Distance	The change demonstrated in clinical test of single limb reach/balance in the anterior, posterolateral, and posteriomedial directions in cm	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Center of pressure during walking gait	Changes in center of pressure during walking gait	Arm 1 and Arm 2: Baseline, 2 wk, 4 wk, 8 wk. Arm 3: Baseline 4 wk, 8 wk

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in foot posture over loading conditions	Change in navicular height from 10% weight bearing to 90% weight bearing in mm	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Arch Height Index	Change in arch height from 10% weight bearing to 90% weight bearing relative to truncated foot length (in %)	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Maximal vertical jump height	Maximal height jump off of two feet will be measured in centimeters	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Changes in landing forces	Change in vertical ground reaction force during landing after vertical jump	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Perceived effort in learning novel exercise measured by NASA-Task Load Index (NASA-TLX)	Participant reported workload estimates of Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. RAW TLX will be utilized, with each component considered individually; the subscales will not be combined. Subscales are rated 0-21; higher scores indicate greater load or difficulty	Arm 1 and Arm 2: Supervised training sessions 1, 2, 3, 4, 5, and 6

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Katherine Newsham, PhD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Therapeutic exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: IRB# 29267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No