Lower Extremity BiomechanicsNCT06678139
The Effect of Physiotherapy on Lower Extremity Function and Gait in Children with Isolated Gastrocnemius Muscle Tightness
A study testing physiotherapy in people with Lower Extremity Biomechanics and Gastrocnemius Tightness, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Since the gastrocnemius muscle crosses both joints, the joint kinematics of the ankle are affected by knee flexion. According to the Kendall \& McCreary assessment of normal joint motion angles, the generally accepted normal range of motion for ankle dorsiflexion is 20° when the knee joint is in extension and can… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Lower Extremity Biomechanics, Gastrocnemius Tightness, Pes Planovalgus
- What is being tested?
- physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 22 Mar 2025
- Phase
- Interventional
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of bilateral pes planovalgus due to the isolated gastrocneius tightness
- Being the ages between 4-10 years old
- Having body mass index between within normal limits
Who cannot join
- Presence of high femoral anteversion (Craig test > 30 degrees) and/or internal tibial torsion and/or metatursus adductus
- Having of leg length discrepancy
- Accompanying any neurological, rheumatologic, musculoskeletal, metabolic and connective tissue disease
- Presence of pain associated with the vertebral column and lower extremities
- Presence of any lower extremity and/or vertebral column deformity or history of surgery
- Cognitive, mental, serious psychiatric illness
- Participation in any exercise program and/or sportive activity in the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul, Istanbul, 34050
About this study
Official title: The Effect of a Physiotherapy on Lower Extremity Function and Gait in Children with Isolated Gastrocnemius Muscle Tightness
Since the gastrocnemius muscle crosses both joints, the joint kinematics of the ankle are affected by knee flexion. According to the Kendall \& McCreary assessment of normal joint motion angles, the generally accepted normal range of motion for ankle dorsiflexion is 20° when the knee joint is in extension and can approach 30° when the knee joint is flexed due to relaxation of the gastrocnemius. In the mid-stance phase of gait, it is observed that the ankle joint allows 8-10° dorsi flexion movement.
In this study, a minimum 13° increase in dorsiflexion with knee flexion compared to dorsiflexion with knee extension will be considered as isolated gastrocnemius muscle tightness. Isolated gastrocnemius muscle tightness has been associated with many biomechanical changes such as pes planus, talar equinus, hindfoot pronation and symptoms such as plantar fasciitis, leg pain, metatarsalgia, achilles tendinopathy by compensatory effects on the lower extremity and foot during gait. The association of increased hindfoot pronation with isolated gastrocnemius tightness has been shown in many studies. Regardless of the etiology of pronation of the hindfoot, there will be adaptive isolated gastrocnemius tightness with talar plantar flexion. Isolated gastrocnemius tightness, which causes plantar flexion in the ankle joint and pronation in the subtalar joint, also prevents the distribution of the load to the base of the foot within normal limits during weight bearing. However, no study investigating the effect of physiotherapy program on function and gait has been encountered. The aim of this study was to investigate the effect of a physiotherapy program on lower extremity function and gait in children with isolated gastrocnemius muscle tightness.
- Being tested
- physiotherapy
- Keywords
- Isolated gastrocnemius muscle tightness, physiotherapy, lower extremity function, gait
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
Bilateral gastrosoleus stretching, iliopsoas and hamstring stretching (if a shortness is detected), foot intrinsic and extrinsic muscle strengthening, lower extremity muscle strengthening and parkour walking training will be performed. Therapeutic exercises will be performed once a week for 12 weeks under the supervision of a physiotherapist. Parents will be asked to follow a 12-week home exercise program at home during the five days. The home exercise program will include the exercises performed in the pediatric physiotherapy and research laboratory. Parents will be instructed to perform each exercise twice a day at home. Children will be given a weekly exercise diary to increase adherence to the exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Exercise group Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analyses with Kinovea ® software
The following assessments will be carried out before starting the exercise program. Then the children will be positioned at the beginning of the prepared 5-meter walking path with their underwear on. First, they will be asked to take trial walks and then they will be asked to walk 5 times on this path at their normal walking pace. Video recordings will be taken from frontal (antero-posterior) and sagittal (lateral) planes with a camera placed on a tripod. The same assessments and video recordings will be repeated at the end of the 12-week physiotherapy program. Observational gait analysis will be performed by scoring with the Edinburg Observational Gait Scoring using the frame-by-frame tracking feature of the video. Video recordings of the children obtained from 3 different angles (anterior-posterior-lateral) will be monitored and scored in slow motion with Kinovea ® software
Measured: Baseline and immediately after the physiotherapy program
Edinburgh Observational Gait Score
The Edinburgh Observational Gait Score is an easy-to-use, reliable visual scoring system. In 2003, Read et al. developed this scoring system by identifying the key points of pathologic gait in CP. It has 17 parameters evaluating gait in sagittal, coronal and transverse planes, selected in association with computerized gait analysis. It allows the evaluation of archived gait videos for trunk, pelvis, hip, knee, ankle and foot according to the phases of gait.
Measured: Baseline and immediately after the physiotherapy program
Lower Extremity Function Scale
It is a test completed by the parents to assess health-related quality of life. It includes some activities that require the use of the foot and leg in daily life. The degree of difficulty of the child with isolated gastrocnemius muscle tightness to perform these activities is scored between 0 (not difficult) and 4 (unable). As the test score gets closer to 0 (zero), the functional level of the child increases.
Measured: Baseline and immediately after the physiotherapy program
Secondary outcomes (3)
Foot Posture Index (FPI-6)
It is a practical method that provides information about the alignment disorders of the foot and allows evaluation in multiple plans. FPI-6 is a scoring system in the range of -12 and +12 obtained by scoring the data in the range of +2 and -2 for 6 separate analyzes. The evaluation will be performed in the position in which the children feel comfortable, with their arms at their sides, in a standing posture while looking straight ahead. Each analysis will be scored on a 5-point scale (+2, +1, 0, -1, -2) with positive values indicating pronation and negative values indicating supination.
Measured: Baseline and immediately after the physiotherapy program
Navicular Drop Test
The navicular drop test is a test used clinically to determine the presence and degree of pes planus. In this test, the navicular tubercle is first palpated and marked and the distance between the navicular tubercle and the floor is measured while the person is in a sitting position and the feet are only in contact with the floor (without weight on the feet). The distance between the navicular tubercle and the floor is then measured again with the person standing up and putting equal weight on the feet. Measurements will be made bilaterally and recorded in millimeters (mm). In the navicular drop test, the difference between weighted and unweighted measurements between 5-9 mm is considered normal (neutral), 10 mm or more is considered pronation, and 4 mm or less is considered supination.
Measured: Baseline and immediately after the physiotherapy program
Sit to Stand Test
The child will be asked to get up from a chair without armrests and sit back down again with his/her hips and knees flexed at 90° and feet in full contact with the floor. The number of sit-ups within 30 seconds will be recorded with a stopwatch.
Measured: Baseline and immediately after the physiotherapy program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start20 Oct 2024
- Primary completion22 Mar 2025
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity BiomechanicsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678139
- Sponsor's protocol ID
- 12.10.2024-168536
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tuncer D, Eren Zengin F, Senaran H, Uzer G. The effect of a 12-week physiotherapy program on lower extremity function and gait in children with isolated gastrocnemius tightness. Physiother Theory Pract. 2025 Dec;41(12):2605-2616. doi: 10.1080/09593985.2025.2542415. Epub 2025 Aug 6.
PubMed 40767345
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Physiotherapy on Lower Extremity Function and Gait in Children with Isolated Gastrocnemius Muscle Tightness
- ClinicalTrials.gov ID
- NCT06678139
- Acronym / sponsor ID
- 12.10.2024-168536
- Keywords
- Isolated gastrocnemius muscle tightness, physiotherapy, lower extremity function, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 7 Nov 2024 (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.
Since the gastrocnemius muscle crosses both joints, the joint kinematics of the ankle are affected by knee flexion. According to the Kendall \& McCreary assessment of normal joint motion angles, the generally accepted normal range of motion for ankle dorsiflexion is 20° when the knee joint is in extension and can approach 30° when the knee joint is flexed due to relaxation of the gastrocnemius. In the mid-stance phase of gait, it is observed that the ankle joint allows 8-10° dorsi flexion movement.
In this study, a minimum 13° increase in dorsiflexion with knee flexion compared to dorsiflexion with knee extension will be considered as isolated gastrocnemius muscle tightness. Isolated gastrocnemius muscle tightness has been associated with many biomechanical changes such as pes planus, talar equinus, hindfoot pronation and symptoms such as plantar fasciitis, leg pain, metatarsalgia, achilles tendinopathy by compensatory effects on the lower extremity and foot during gait. The association of increased hindfoot pronation with isolated gastrocnemius tightness has been shown in many studies. Regardless of the etiology of pronation of the hindfoot, there will be adaptive isolated gastrocnemius tightness with talar plantar flexion. Isolated gastrocnemius tightness, which causes plantar flexion in the ankle joint and pronation in the subtalar joint, also prevents the distribution of the load to the base of the foot within normal limits during weight bearing. However, no study investigating the effect of physiotherapy program on function and gait has been encountered. The aim of this study was to investigate the effect of a physiotherapy program on lower extremity function and gait in children with isolated gastrocnemius muscle tightness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: physiotherapyExercise group |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Presence of bilateral pes planovalgus due to the isolated gastrocneius tightness
- Being the ages between 4-10 years old
- Having body mass index between within normal limits
Key exclusion criteria (7 listed)
- Presence of high femoral anteversion (Craig test > 30 degrees) and/or internal tibial torsion and/or metatursus adductus
- Having of leg length discrepancy
- Accompanying any neurological, rheumatologic, musculoskeletal, metabolic and connective tissue disease
- Presence of pain associated with the vertebral column and lower extremities
- Presence of any lower extremity and/or vertebral column deformity or history of surgery
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 |
|---|---|---|
| physiotherapyBilateral gastrosoleus stretching, iliopsoas and hamstring stretching (if a shortness is detected), foot intrinsic and extrinsic muscle strengthening, lower extremity muscle strengthening and parkour walking training will be performed. Therapeutic exercises will be performed once a week for 12 weeks under the supervision of a physiotherapist. Parents will be asked to follow a 12-week home exercise program at home during the five days. The home exercise program will include the exercises performed in the pediatric physiotherapy and research laboratory. Parents will be instructed to perform each exercise twice a day at home. Children will be given a weekly exercise diary to increase adherence to the exercise program. | Other | Study Group |
Primary outcome
Gait analyses with Kinovea ® software
Time frame: Baseline and immediately after the physiotherapy program
The following assessments will be carried out before starting the exercise program. Then the children will be positioned at the beginning of the prepared 5-meter walking path with their underwear on. First, they will be asked to take trial walks and then they will be asked to walk 5 times on this path at their normal walking pace. Video recordings will be taken from frontal (antero-posterior) and sagittal (lateral) planes with a camera placed on a tripod. The same assessments and video recordings will be repeated at the end of the 12-week physiotherapy program. Observational gait analysis will be performed by scoring with the Edinburg Observational Gait Scoring using the frame-by-frame tracking feature of the video. Video recordings of the children obtained from 3 different angles (anterior-posterior-lateral) will be monitored and scored in slow motion with Kinovea ® software
Edinburgh Observational Gait Score
Time frame: Baseline and immediately after the physiotherapy program
The Edinburgh Observational Gait Score is an easy-to-use, reliable visual scoring system. In 2003, Read et al. developed this scoring system by identifying the key points of pathologic gait in CP. It has 17 parameters evaluating gait in sagittal, coronal and transverse planes, selected in association with computerized gait analysis. It allows the evaluation of archived gait videos for trunk, pelvis, hip, knee, ankle and foot according to the phases of gait.
Lower Extremity Function Scale
Time frame: Baseline and immediately after the physiotherapy program
It is a test completed by the parents to assess health-related quality of life. It includes some activities that require the use of the foot and leg in daily life. The degree of difficulty of the child with isolated gastrocnemius muscle tightness to perform these activities is scored between 0 (not difficult) and 4 (unable). As the test score gets closer to 0 (zero), the functional level of the child increases.
3 secondary outcomes
Foot Posture Index (FPI-6)
Time frame: Baseline and immediately after the physiotherapy program
Navicular Drop Test
Time frame: Baseline and immediately after the physiotherapy program
Sit to Stand Test
Time frame: Baseline and immediately after the physiotherapy program
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 26 Mar 2025.
- Derived from this study: PubMed 40767345Tuncer D, Eren Zengin F, Senaran H, Uzer G. The effect of a 12-week physiotherapy program on lower extremity function and gait in children with isolated gastrocnemius tightness. Physiother Theory Pract. 2025 Dec;41(12):2605-2616. doi: 10.1080/09593985.2025.2542415. Epub 2025 Aug 6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Lower Extremity Biomechanics and Gastrocnemius Tightness, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 26 Mar 2025. 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 Turkey (Türkiye). 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?
Gait analyses with Kinovea ® software (time frame: Baseline and immediately after the physiotherapy program). The study lists 3 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 NCT06678139, which also lists 1 linked publication.
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 26 Mar 2025.