Effect of Heel Lift Insole on Kinematics and Kinetics of the Lower Limb and Lumbar Spine Among Healthy Individuals

NCT07047300 | Recruiting

• 1 other identifier: P.T.REC/012/005801
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This observational study aims to investigate the effect of heel lift insole on kinematics and kinetics of the lower limb and lumbar spine among healthy individuals.

Conditions

Healthy Individuals

Keywords

Heel Lift Insole; Electromyography (EMG); Kinetics; Kinematics; Lower Limb; Lumbar spine; Kinovea software

Outcome Measures

Primary Outcomes (1)

• Muscle activity (Maximum amplitude in microvolt) - Electromyography Device Using interference pattern

  3 Months

Secondary Outcomes (2)

• Q-Angle using objective Kinovea 2D software

  3 months

• Lumbo-Sacral Angle using objective Kinovea 2D software

  3 Months

Study Arms (2)

Males Group (Group A)

Diagnostic Test: Record EMG maximum amplitude from bilateral erector spinae, rectus femoris, and medial and lateral gastrocnemius muscles.; Diagnostic Test: Photograph participants from anterior and lateral views to assess knee valgus angle and lumbosacral angle.

Females Group (Group B)

Diagnostic Test: Record EMG maximum amplitude from bilateral erector spinae, rectus femoris, and medial and lateral gastrocnemius muscles.; Diagnostic Test: Photograph participants from anterior and lateral views to assess knee valgus angle and lumbosacral angle.

Interventions

Record EMG maximum amplitude from bilateral erector spinae, rectus femoris, and medial and lateral gastrocnemius muscles. DIAGNOSTIC_TEST

Conduct measurements under two conditions: Condition 1: Standing with standardized flat shoes. Perform three trials for each participant. Calculate and record the mean as baseline data. Condition 2: Standing with a standardized heel lift insole inside the flat shoes. Conduct three trials. Record the mean for comparative analysis.

Females Group (Group B); Males Group (Group A)

Photograph participants from anterior and lateral views to assess knee valgus angle and lumbosacral angle. DIAGNOSTIC_TEST

Capture two sets of photographs for each participant: Set 1: Wearing flat shoes. Set 2: Wearing the heel lift insole inside the flat shoes. Compare knee valgus angle and lumbosacral angle under both conditions. Ensure consistency and reliability by following standardized protocols and performing repeated measurements. Analyze the effects of heel lift insoles on muscle activity and postural alignment.

Females Group (Group B); Males Group (Group A)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Individuals

You may qualify if:

• Adult non-athletic individuals with age range between (18: 25) years old (Joshi et al., 2024).
• Height between (160 - 180 cm).
• Body mass index between (18.5:24.99) Kg/ m² (Joshi et al., 2024).
• Foot length between (23,3 - 28.0 cm).
• Never used heel lift insole.
• Participants must have a normal and pain-free range of motion in the lower limbs and spine (Hapsari et al., 2016).
• Participants must demonstrate stable balance and coordination in weight-bearing activities (Hapsari et al., 2016).

You may not qualify if:

• Traumatic conditions of the lower limb (Joshi et al., 2024).
• Pelvis and lower limb musculoskeletal disorders (Joshi et al., 2024).
• Previous orthopedic disorders or neurological deficit of the lower limb (Joshi et al., 2024).
• Previous surgery of the lower limbs (Lindenberg et al., 2019).
• Any sensory problems.
• Neuromuscular diseases such as multiple sclerosis, intervertebral disc disorders…etc (Joshi et al., 2024).
• Pregnancy.
• Cancer Patients.
• Immunodeficiency diseases.
• Psychological disorders (depression - anxiety).
• Chronic diseases as (diabetes - hypertension).
• Participants with lower limbs deformity (Joshi et al., 2024).
• Participants with specific lower limb muscles weakness.
• Low back pain in the past 30 days (Colonna et al., 2024).

Sponsors & Collaborators

• Cairo University: lead
• Misr University for Science and Technology: collaborator

Study Sites (2)

Misr University for science and technology

Giza, Giza Governorate, Egypt

NOT YET RECRUITING

Misr University for science and technology, Physical Therapy College, EMG and NCV Lab

Giza, Egypt

RECRUITING

Central Study Contacts

Abdelrahman Salah Sawan, Bachelor's degree

CONTACT

+201144047770; abdelrahman.sawan@must.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)