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Training Intrinsic Foot Muscles

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ClinicalTrials.gov Identifier: NCT03670563
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Newsham PhD, ATC, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Muscular Weakness Other: Short foot exercise protocol Other: Short foot exercise plus NMES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with two intervention arms and one control arm
Masking: Single (Outcomes Assessor)
Masking Description: Team members collecting outcomes data will not know participant allocation
Primary Purpose: Treatment
Official Title: Training Intrinsic Foot Muscles
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670563


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Katherine Newsham, PhD St. Louis University
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Responsible Party: Katherine Newsham PhD, ATC, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT03670563    
Other Study ID Numbers: IRB# 29267
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katherine Newsham PhD, ATC, St. Louis University:
Therapeutic exercise
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms