Training Intrinsic Foot Muscles

Sponsor
St. Louis University (Other)
Overall Status
Completed
CT.gov ID
NCT03670563
Collaborator
(none)
39
1
3
5.8
6.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Short foot exercise protocol
  • Other: Short foot exercise plus NMES
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial with two intervention arms and one control armRandomized 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 :
Oct 10, 2018
Actual Primary Completion Date :
Apr 5, 2019
Actual Study Completion Date :
Apr 5, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reaching Distance [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 [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 [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 [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 [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 [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) [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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Louis University Saint Louis Missouri United States 63104

Sponsors and Collaborators

  • St. Louis University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katherine Newsham PhD, ATC, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier:
NCT03670563
Other Study ID Numbers:
  • IRB# 29267
First Posted:
Sep 13, 2018
Last Update Posted:
May 3, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Associate Professor, St. Louis University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2019