NCT05015088

Brief Summary

The aims of this study are to: (1) determine muscle activation of the tibialis posterior muscle during different common gastrocnemius stretches and (2) radiographically quantify the tibial-calcaneal angle during the common stretching positions. We hypothesize that stretching over the edge of a step with the arch supported will minimize the activation of the tibialis posterior muscle in addition to increasing the tibial-calcaneal angle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

August 11, 2021

Last Update Submit

October 6, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • EMG activation

    EMG activation of tibialis posterior muscle during 4 common gastrocnemius stretching positions

    up to 6 months

  • Radiographic evaluation

    radiographically the angle of the tibia-calcaneus axis and calcaneal pitch between four different common gastrocnemius stretches

    up to 6 months

Secondary Outcomes (1)

  • Relationship between foot posture and radiographic evaluation of tibia-calcaneal angle

    up to 6 months

Study Arms (1)

Gastrocnemius Stretching Group

The study will enroll 20 healthy subjects between the ages of 18 to 65 years old. Individuals will be recruited from multiple locations. Exclusion criteria include: any boney or tendinous foot/ankle operative procedure, diagnosis of neuromuscular disorder, any previous ankle fracture or degenerative changes that would limit dorsiflexion range of motion. Participants must have no obvious gait asymmetries demonstrated through observation. In addition, participants who are pregnant will be excluded from participation in the study.

Other: No interventions will be performed in this study

Interventions

This study will not include any intervention

Gastrocnemius Stretching Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals

You may qualify if:

  • 20 healthy subjects between the ages of 18 to 65 years old.

You may not qualify if:

  • any boney or tendinous foot/ankle operative procedure
  • diagnosis of neuromuscular disorder
  • any previous ankle fracture or degenerative changes that would limit dorsiflexion range of motion
  • no obvious gait asymmetries demonstrated through observation
  • participants who are pregnant will be excluded from participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

Related Publications (5)

  • Mueller TJ. Acquired flatfoot secondary to tibialis posterior dysfunction: biomechanical aspects. J Foot Surg. 1991 Jan-Feb;30(1):2-11.

    PMID: 2002182BACKGROUND
  • Thordarson DB, Schmotzer H, Chon J, Peters J. Dynamic support of the human longitudinal arch. A biomechanical evaluation. Clin Orthop Relat Res. 1995 Jul;(316):165-72.

    PMID: 7634700BACKGROUND
  • Huang CK, Kitaoka HB, An KN, Chao EY. Biomechanical evaluation of longitudinal arch stability. Foot Ankle. 1993 Jul-Aug;14(6):353-7. doi: 10.1177/107110079301400609.

    PMID: 8406252BACKGROUND
  • DiGiovanni CW, Kuo R, Tejwani N, Price R, Hansen ST Jr, Cziernecki J, Sangeorzan BJ. Isolated gastrocnemius tightness. J Bone Joint Surg Am. 2002 Jun;84(6):962-70. doi: 10.2106/00004623-200206000-00010.

    PMID: 12063330BACKGROUND
  • Maeda N, Komiya M, Nishikawa Y, Morikawa M, Tsutsumi S, Tashiro T, Fukui K, Kimura H, Urabe Y. Effect of Acute Static Stretching on the Activation Patterns Using High-Density Surface Electromyography of the Gastrocnemius Muscle during Ramp-Up Task. Sensors (Basel). 2021 Jul 15;21(14):4841. doi: 10.3390/s21144841.

    PMID: 34300581BACKGROUND

Study Officials

  • Stephanie Albin, PhD

    Regis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 20, 2021

Study Start

May 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 15, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations