NCT06678139

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2025

Completed
Last Updated

March 26, 2025

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 4, 2024

Last Update Submit

March 22, 2025

Conditions

Keywords

Isolated gastrocnemius muscle tightnessphysiotherapylower extremity functiongait

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    Baseline and immediately after the physiotherapy program

Secondary Outcomes (3)

  • Foot Posture Index (FPI-6)

    Baseline and immediately after the physiotherapy program

  • Navicular Drop Test

    Baseline and immediately after the physiotherapy program

  • Sit to Stand Test

    Baseline and immediately after the physiotherapy program

Study Arms (1)

Study Group

EXPERIMENTAL

Exercise group

Other: physiotherapy

Interventions

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

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Istanbul, Istanbul, 34050, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Clubfoot

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 7, 2024

Study Start

October 20, 2024

Primary Completion

March 22, 2025

Study Completion

March 22, 2025

Last Updated

March 26, 2025

Record last verified: 2024-11

Locations