Training Intrinsic Foot Muscles

NCT03670563 | Completed

• 1 other identifier: IRB# 29267
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Weakness

Keywords

Therapeutic exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes in foot posture over loading conditions

  Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks

• Arch Height Index

  Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks

• Maximal vertical jump height

  Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks

• Changes in landing forces

  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)

  Arm 1 and Arm 2: Supervised training sessions 1, 2, 3, 4, 5, and 6

Study Arms (3)

Exercise 1

EXPERIMENTAL

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

Other: Short foot exercise protocol

Exercise 2

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Short foot exercise protocol OTHER

Exercises that target intrinsic foot muscles

Exercise 1

Short foot exercise plus NMES OTHER

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

Exercise 2

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Katherine Newsham, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Team members collecting outcomes data will not know participant allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial with two intervention arms and one control arm

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: October 10, 2018
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)