Gastrocnemius TightnessGastrocNCT05015088
Effectiveness of Gastrocnemius Stretching
An observational study of Gastrocnemius Tightness, run by Regis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrocnemius Tightness
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals
Who may be able to join
- 20 healthy subjects between the ages of 18 to 65 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Many studies have assessed the effect of dynamic and passive support of the medial longitudinal arch. The posterior tibial tendon is the main dynamic stabilizer of the medial longitudinal arch, although peroneus/fibularis longus, flexor digitorum longus, and flexor hallucis longus also contribute to a lesser degree. Passive structures also a play role in supporting the arch and include the plantar fascia, plantar ligaments and spring ligament. These plantar structures aid in preventing collapse of the arch during weight bearing.
Several studies have demonstrated that increased tension from the triceps surae can lead to flattening of the arch. Gastrocnemius muscle tightness in particular is thought to be partially responsible for many forefoot and midfoot conditions in non-neurologically impaired patients. Therefore, identifying effective ways to stretch the gastrocnemius muscle without creating increased stress through dynamic structures that support the longitudinal arch may be important for the management of individuals with limited gastrocnemius flexibility.
Common ways to stretch the gastrocnemius include a runner's stretch, stretching with the foot fully supported on a ramp, stretching with the arch of the foot supported on the edge of step and the heel dropping down toward the ground and lastly, stretching with the ball of the foot supported on the edge of a step and the heel dropping down toward the ground. To our knowledge no other studies have assessed the muscle activation of the tibialis posterior muscle via indwelling EMG activation in addition to radiographic measurements to determine the effectiveness of common gastrocnemius stretches. Therefore, the aims of this study are to determine muscle activation of the tibialis posterior muscle during different common gastrocnemius stretches and to radiographically quantify the tibial-calcaneal angle. 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 more than the other stretching positions.
- Conditions
- Gastrocnemius Tightness
- Being tested
- No interventions will be performed in this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions will be performed in this studyOther
This study will not include any intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No interventions will be performed in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG activation
EMG activation of tibialis posterior muscle during 4 common gastrocnemius stretching positions
Measured: up to 6 months
Radiographic evaluation
radiographically the angle of the tibia-calcaneus axis and calcaneal pitch between four different common gastrocnemius stretches
Measured: up to 6 months
Secondary outcomes (1)
Relationship between foot posture and radiographic evaluation of tibia-calcaneal angle
Assess if there is a relationship between radiographic stretching position and foot posture
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 May 2022
- Primary completion1 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastrocnemius TightnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regis University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Stephanie Albin, Regis University
- Investigators
- Stephanie Albin, PhD, Principal investigator, Regis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015088
- Sponsor's protocol ID
- COMIRB
- Acronym
- Gastroc
- Status last verified
- Oct 2023
- First submitted
- 11 Aug 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mueller TJ. Acquired flatfoot secondary to tibialis posterior dysfunction: biomechanical aspects. J Foot Surg. 1991 Jan-Feb;30(1):2-11.
PubMed 2002182Thordarson 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.
PubMed 7634700Huang 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.
PubMed 8406252DiGiovanni 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.
PubMed 12063330Maeda 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.
PubMed 34300581
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gastrocnemius Stretching
- ClinicalTrials.gov ID
- NCT05015088
- Acronym / sponsor ID
- Gastroc / COMIRB
- Conditions
- Gastrocnemius Tightness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regis UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Many studies have assessed the effect of dynamic and passive support of the medial longitudinal arch. The posterior tibial tendon is the main dynamic stabilizer of the medial longitudinal arch, although peroneus/fibularis longus, flexor digitorum longus, and flexor hallucis longus also contribute to a lesser degree. Passive structures also a play role in supporting the arch and include the plantar fascia, plantar ligaments and spring ligament. These plantar structures aid in preventing collapse of the arch during weight bearing.
Several studies have demonstrated that increased tension from the triceps surae can lead to flattening of the arch. Gastrocnemius muscle tightness in particular is thought to be partially responsible for many forefoot and midfoot conditions in non-neurologically impaired patients. Therefore, identifying effective ways to stretch the gastrocnemius muscle without creating increased stress through dynamic structures that support the longitudinal arch may be important for the management of individuals with limited gastrocnemius flexibility.
Common ways to stretch the gastrocnemius include a runner's stretch, stretching with the foot fully supported on a ramp, stretching with the arch of the foot supported on the edge of step and the heel dropping down toward the ground and lastly, stretching with the ball of the foot supported on the edge of a step and the heel dropping down toward the ground. To our knowledge no other studies have assessed the muscle activation of the tibialis posterior muscle via indwelling EMG activation in addition to radiographic measurements to determine the effectiveness of common gastrocnemius stretches. Therefore, the aims of this study are to determine muscle activation of the tibialis posterior muscle during different common gastrocnemius stretches and to radiographically quantify the tibial-calcaneal angle. 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 more than the other stretching positions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastrocnemius Stretching Group | – | Other: No interventions will be performed in this studyThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals
Key inclusion criteria (1 listed)
- 20 healthy subjects between the ages of 18 to 65 years old.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions will be performed in this studyThis study will not include any intervention | Other | Gastrocnemius Stretching Group |
Primary outcome
EMG activation
Time frame: up to 6 months
EMG activation of tibialis posterior muscle during 4 common gastrocnemius stretching positions
Radiographic evaluation
Time frame: up to 6 months
radiographically the angle of the tibia-calcaneus axis and calcaneal pitch between four different common gastrocnemius stretches
1 secondary outcome
Relationship between foot posture and radiographic evaluation of tibia-calcaneal angle
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 2002182Mueller TJ. Acquired flatfoot secondary to tibialis posterior dysfunction: biomechanical aspects. J Foot Surg. 1991 Jan-Feb;30(1):2-11.
- Background: PubMed 7634700Thordarson 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.
- Background: PubMed 8406252Huang 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.
- Background: PubMed 12063330DiGiovanni 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.
- Background: PubMed 34300581Maeda 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.
- Individual participant dataSharing planned: Undecided
Related trials for Gastrocnemius Tightness
RecruitingObservational study
Isolated Gastrocnemius Tightness and Tactile Sensitivity
Isolated Gastrocnemius Tightness, Healthy Adult Participants
RecruitingObservational study
Gastrocnemius Tightness and Foot Pain in Children
Child Development, Gastrocnemius Equinus
RecruitingObservational study
Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a
Plantar Fascitis, Gastrocnemius Tightness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Albin, PhD principal investigator
Regis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrocnemius Tightness, run by Regis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG activation (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05015088, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.