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Training Intrinsic Foot Muscles

Primary Purpose

Muscular Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short foot exercise protocol
Short foot exercise plus NMES
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Weakness focused on measuring Therapeutic exercise

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Exercise 1

Exercise 2

Control

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Reaching Distance
The change demonstrated in clinical test of single limb reach/balance in the anterior, posterolateral, and posteriomedial directions in cm
Center of pressure during walking gait
Changes in center of pressure during walking gait

Secondary Outcome Measures

Changes in foot posture over loading conditions
Change in navicular height from 10% weight bearing to 90% weight bearing in mm
Arch Height Index
Change in arch height from 10% weight bearing to 90% weight bearing relative to truncated foot length (in %)
Maximal vertical jump height
Maximal height jump off of two feet will be measured in centimeters
Changes in landing forces
Change in vertical ground reaction force during landing after vertical jump
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

Full Information

First Posted
September 11, 2018
Last Updated
May 1, 2019
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT03670563
Brief Title
Training Intrinsic Foot Muscles
Official Title
Training Intrinsic Foot Muscles
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Weakness
Keywords
Therapeutic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two intervention arms and one control arm
Masking
Outcomes Assessor
Masking Description
Team members collecting outcomes data will not know participant allocation
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise 1
Arm Type
Experimental
Arm Description
Short foot exercise protocol instructed utilizing verbal instruction, passive modeling, active-assisted modeling, and active modeling.
Arm Title
Exercise 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise intervention; continue normal physical activity, but do not start any new exercise programs
Intervention Type
Other
Intervention Name(s)
Short foot exercise protocol
Intervention Description
Exercises that target intrinsic foot muscles
Intervention Type
Other
Intervention Name(s)
Short foot exercise plus NMES
Intervention Description
Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education
Primary Outcome Measure Information:
Title
Reaching Distance
Description
The change demonstrated in clinical test of single limb reach/balance in the anterior, posterolateral, and posteriomedial directions in cm
Time Frame
Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Title
Center of pressure during walking gait
Description
Changes in 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
Secondary Outcome Measure Information:
Title
Changes in foot posture over loading conditions
Description
Change in navicular height from 10% weight bearing to 90% weight bearing in mm
Time Frame
Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Title
Arch Height Index
Description
Change in arch height from 10% weight bearing to 90% weight bearing relative to truncated foot length (in %)
Time Frame
Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Title
Maximal vertical jump height
Description
Maximal height jump off of two feet will be measured in centimeters
Time Frame
Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Title
Changes in landing forces
Description
Change in vertical ground reaction force during landing after vertical jump
Time Frame
Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Title
Perceived effort in learning novel exercise measured by NASA-Task Load Index (NASA-TLX)
Description
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
Time Frame
Arm 1 and Arm 2: Supervised training sessions 1, 2, 3, 4, 5, and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Newsham, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Training Intrinsic Foot Muscles

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