Training Intrinsic Foot Muscles

Muscular Weakness Clinical Trial

Official title:

Training Intrinsic Foot Muscles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670563
• Other study ID #: IRB# 29267
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: April 5, 2019

Study information

• Verified date: May 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Muscular Weakness

Intervention

Other:
• Short foot exercise protocol
Exercises that target intrinsic foot muscles
• Short foot exercise plus NMES
Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in foot posture over loading conditions	Change in navicular height from 10% weight bearing to 90% weight bearing in mm	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Secondary	Arch Height Index	Change in arch height from 10% weight bearing to 90% weight bearing relative to truncated foot length (in %)	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Secondary	Maximal vertical jump height	Maximal height jump off of two feet will be measured in centimeters	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Secondary	Changes in landing forces	Change in vertical ground reaction force during landing after vertical jump	Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Secondary	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	Arm 1 and Arm 2: Supervised training sessions 1, 2, 3, 4, 5, and 6