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Completed

NCT Number: NCT03670563

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.

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Key information

Conditions

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

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University

St Louis, Missouri, 63104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short foot exercise protocol

Other

Exercises that target intrinsic foot muscles

Short foot exercise plus NMES

Other

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

Primary outcomes

  1. Reaching Distance

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

    The change demonstrated in clinical test of single limb reach/balance in the anterior, posterolateral, and posteriomedial directions in cm

  2. Center of pressure during walking gait

    Time frame: Arm 1 and Arm 2: Baseline, 2 wk, 4 wk, 8 wk. Arm 3: Baseline 4 wk, 8 wk

    Changes in center of pressure during walking gait

Secondary outcomes

  1. Changes in foot posture over loading conditions

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

    Change in navicular height from 10% weight bearing to 90% weight bearing in mm

  2. Arch Height Index

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

    Change in arch height from 10% weight bearing to 90% weight bearing relative to truncated foot length (in %)

  3. Maximal vertical jump height

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

    Maximal height jump off of two feet will be measured in centimeters

  4. Changes in landing forces

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

    Change in vertical ground reaction force during landing after vertical jump

  5. Perceived effort in learning novel exercise measured by NASA-Task Load Index (NASA-TLX)

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

    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

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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