Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06363136
Other study ID # 14.06.2023-111176
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Bezmialem Vakif University
Contact Deniz Tuncer, PhD, PT
Phone +905354273757
Email dtuncer@bezmialem.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with increasing age in children. It is not known whether gastrocnemius tightness is a normal finding in children, but recurrent leg pain is common in children. It is also known that flexible flatfoot is a normal observation in developing children and that the medial longitudinal arch develops during the first decade of life. Both foot morphology and ankle dorsiflexion change in developing children; however, it is not known whether there is a relationship between them or not. In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle tightness. It was planned to evaluate postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-foot-double-foot jump tests in healthy children with isolated gastrocnemius muscle tightness.


Description:

Since the gastrocnemius muscle spans both joints, the kinematics of the ankle joint are influenced by knee flexion. According to Kendall & McCreary's assessment of normal joint motion angles, when the knee joint is in extension, the passive dorsiflexion angle of the ankle is approximately 20°, and with knee flexion, the angle can approach 30° due to the relaxation of the gastrocnemius. During the midstance phase of walking, the ankle joint allows for 8-10° of dorsiflexion movement. The evaluation of gastrocnemius muscle tightness is conducted using the Silfverskiold method. However, there are variations in the definitions proposed for the detection of isolated gastrocnemius tightness. In our investigation, when ankle dorsiflexion rises by at least 10° more in knee flexion than knee extension, isolated gastrocnemius tightness will be taken into account. Isolated gastrocnemius tightness during walking can result in compensatory effects on the lower extremity and foot, causing biomechanical changes such as pes planus, talus eversion, rearfoot pronation, and various symptoms such as plantar fasciitis, leg pain, metatarsalgia, and Achilles tendinopathy. The association between increased rearfoot pronation and isolated gastrocnemius tightness has been demonstrated in the literature. Regardless of the etiology of rearfoot pronation, adaptive isolated gastrocnemius shortening will occur in conjunction with talar plantar flexion. Isolated gastrocnemius tightness causing plantar flexion at the ankle joint and pronation at the subtalar joint also hinders the normal distribution of load on the plantar surface during weight-bearing. Reviewing the literature, it is observed that the effects of isolated gastrocnemius tightness on foot posture, functional parameters, and gait dynamics, especially rearfoot pronation, are reported. Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with age in children. While it is unknown whether gastrocnemius shortening is a normal finding in children, recurrent leg pain is common in children. Additionally, flexible flatfoot is considered a normal observation in developing children, and it is known that the medial longitudinal arch develops in the first ten years of life. Both foot morphology and ankle dorsiflexion change in developing children, but it is unknown whether there is a relationship between the two. In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle shortening. In our study, we plan to assess postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-leg and double-leg hop tests in healthy children with isolated gastrocnemius muscle shortening.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date June 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 16 Years
Eligibility Inclusion Criteria: Study group - Presence of bilateral isolated gastrocnemius tightness (The test is considered positive when ankle dorsal flexion dorsiflexion increases over a minimum of 10 degrees with the knee flexed than the knee extension. - Being between 7-16 years of age - Body mass index within normal limits (18.5-24.9 kg/m2) Exclusion criteria - Presence of high femoral anteversion, internal tibial torsion, and metatarsus adductus - Presence of hypermobility (Beighton score >4 and above) - Leg length discrepancy - Presence of any neurological, rheumatic, musculoskeletal, metabolic, and connective tissue disease - History of pain, deformity, or surgery associated with the vertebral column and lower extremities - Presence of cognitive, mental, and/or severe psychiatric illness - Participation in any exercise program or sportive activity in the last six months For the control group, the same inclusion/exclusion criteria will be accepted except that the bilateral Silfverskiold test is negative.

Study Design


Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural Control Assessment Postural stability, limits of stability, and sensory integration of balance will be assessed using the Biodex Balance System®. 1 day
Primary Lower extremity muscle strength measurement The strength of hip adductors-abductors, external-internal rotators, flexors-extensors, knee flexors-extensors, and ankle dorsiflexors-plantar flexors, invertors-evertors muscles will be evaluated isometrically using a handheld dynamometer (MicroFET 2 force gauge, Hoggan Health Industries, Salt Lake City, Utah). 1 day
Secondary Foot posture assessment The Foot Posture Index (FPI-6) will be used to assess foot alignment in different planes. Six analyses will be scored on a +2 to -2 scale, and the total score will be recorded. 1 day
Secondary Functional performance assessment The Single Leg and Double Leg Horizontal Jump Testswill be used to evaluate lower extremity functional performance. 1 day
See also
  Status Clinical Trial Phase
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Recruiting NCT05945641 - Effect of Low-load Resistance Training vs. High-intensity Interval Training on Local Muscle Endurance N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A
Completed NCT03715920 - Comparison of Different Quadriceps Femoris Isometric Strengthening Methods N/A
Terminated NCT01561404 - Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise Phase 4
Completed NCT04535336 - Vitality Acupunch Exercise Program for Older Adults With Sarcopenia N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT06061315 - Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men N/A
Completed NCT05366348 - The Effects of Horse-back Riding on Core Muscles in Adolescents N/A
Completed NCT04213586 - Effects of Whey Protein and Collagen Supplementation N/A
Completed NCT04626817 - Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study N/A
Completed NCT03922113 - Muscle Function After Intensive Care
Completed NCT01449097 - Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers Phase 4
Completed NCT05882981 - Increased Femoral Anteversion and Physical Performance
Completed NCT06196268 - Core Strengthening vs Pilates Exercises on Posture, Body Awareness and Fatigue Among Female Athletes N/A
Completed NCT00059436 - Mental Effort and Muscle Strength Phase 1
Recruiting NCT06410014 - Assessment of Overall Functioning in Patients With Complex Health Issues
Completed NCT04239417 - Effect of Preoperative Abdominal Exercises and Russian Current on Muscle Strength Post Ventral Hernioplasty N/A
Completed NCT04315077 - The Short Term Effects of Oceanix Supplementation on Recovery N/A