Healthy IndividualsNCT07047300
Effect of Heel Lift Insole on Kinematics and Kinetics of the Lower Limb and Lumbar Spine Among Healthy Individuals
An observational study of Healthy Individuals, run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Record EMG maximum amplitude from bilateral erector spinae, rectus femoris, and medial and lateral gastrocnemius muscles. and Photograph participants from anterior and lateral views to assess knee valgus angle and lumbosacral angle.
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Individuals
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 14Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Misr University for science and technology
Giza, Giza Governorate
Abdelrahman S. Sawan, Bachelor's Degree, +201144047770, abdelrahman.sawan@must.edu.eg
abdelrahman S. Sawan, Bachelor's Degree
- Recruiting
Misr University for science and technology, Physical Therapy College, EMG and NCV Lab
Giza
16878, Info@must.edu.eg
About this study
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.
Read the detailed description
This clinical trial will be conducted among physiotherapy students at Misr University for Science and Technology. Participants will be recruited based on predefined inclusion criteria, and informed consent will be obtained prior to their involvement. Once enrolled, each participant will complete a standardized demographic questionnaire and undergo height and weight measurements to calculate their Body Mass Index (BMI). Those with BMI values outside the normal range, as defined by Shrestha et al. (2023), will be excluded to reduce confounding factors.
Before testing begins, participants will be familiarized with all equipment and procedures. Electromyographic (EMG) data will then be collected to measure maximum muscle activity in the bilateral erector spinae, rectus femoris, and both medial and lateral gastrocnemius muscles. EMG measurements will be taken under two conditions: first, while standing in standardized flat shoes, and second, while wearing a standardized heel lift insole inside the same shoes. Three trials will be performed in each condition, and the mean amplitude will be used for analysis.
In addition to EMG, kinematic data will be assessed using Kinovea software. Photographs will be captured from anterior and lateral views to evaluate each participant's Q angle and lumbosacral angle. As with EMG, these measurements will be repeated under both footwear conditions (flat shoes alone and flat shoes with heel lift insoles), and the results will be compared.
All procedures will follow standardized protocols to ensure consistency and reliability. The primary outcome measure is muscle activity (maximum EMG amplitude), while secondary outcomes include changes in the Q-angle and lumbosacral angle. The study aims to evaluate the impact of heel lift insoles on lower limb muscle activity and postural alignment in healthy individuals.
- Conditions
- Healthy Individuals
- Being tested
- Record EMG maximum amplitude from bilateral erector spinae, rectus femoris, and medial and lateral gastrocnemius muscles., Photograph participants from anterior and lateral views to assess knee valgus angle and lumbosacral angle.
- Keywords
- Heel Lift Insole, Electromyography (EMG), Kinetics, Kinematics, Lower Limb, Lumbar spine, Kinovea software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Males Group (Group A) | Not described Receives: 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) | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity (Maximum amplitude in microvolt) - Electromyography Device Using interference pattern
Measured: 3 Months
Secondary outcomes (2)
Q-Angle using objective Kinovea 2D software
Measured: 3 months
Lumbo-Sacral Angle using objective Kinovea 2D software
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Principal investigator, Abdelrahman Salah Sawan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047300
- Sponsor's protocol ID
- P.T.REC/012/005801
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heel Lift Insole on Kinematics and Kinetics of the Lower Limb and Lumbar Spine Among Healthy Individuals
- ClinicalTrials.gov ID
- NCT07047300
- Acronym / sponsor ID
- P.T.REC/012/005801
- Conditions
- Healthy Individuals
- Keywords
- Heel Lift Insole, Electromyography (EMG), Kinetics, Kinematics, Lower Limb, Lumbar spine, Kinovea software
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 2 Jul 2025 (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.
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.
Detailed description
This clinical trial will be conducted among physiotherapy students at Misr University for Science and Technology. Participants will be recruited based on predefined inclusion criteria, and informed consent will be obtained prior to their involvement. Once enrolled, each participant will complete a standardized demographic questionnaire and undergo height and weight measurements to calculate their Body Mass Index (BMI). Those with BMI values outside the normal range, as defined by Shrestha et al. (2023), will be excluded to reduce confounding factors.
Before testing begins, participants will be familiarized with all equipment and procedures. Electromyographic (EMG) data will then be collected to measure maximum muscle activity in the bilateral erector spinae, rectus femoris, and both medial and lateral gastrocnemius muscles. EMG measurements will be taken under two conditions: first, while standing in standardized flat shoes, and second, while wearing a standardized heel lift insole inside the same shoes. Three trials will be performed in each condition, and the mean amplitude will be used for analysis.
In addition to EMG, kinematic data will be assessed using Kinovea software. Photographs will be captured from anterior and lateral views to evaluate each participant's Q angle and lumbosacral angle. As with EMG, these measurements will be repeated under both footwear conditions (flat shoes alone and flat shoes with heel lift insoles), and the results will be compared.
All procedures will follow standardized protocols to ensure consistency and reliability. The primary outcome measure is muscle activity (maximum EMG amplitude), while secondary outcomes include changes in the Q-angle and lumbosacral angle. The study aims to evaluate the impact of heel lift insoles on lower limb muscle activity and postural alignment in healthy individuals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Individuals
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Record EMG maximum amplitude from bilateral erector spinae, rectus femoris, and medial and lateral gastrocnemius muscles.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. | Diagnostic test | Females Group (Group B), Males Group (Group A) |
| Photograph participants from anterior and lateral views to assess knee valgus angle and lumbosacral angle.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. | Diagnostic test | Females Group (Group B), Males Group (Group A) |
Primary outcome
Muscle activity (Maximum amplitude in microvolt) - Electromyography Device Using interference pattern
Time frame: 3 Months
2 secondary outcomes
Q-Angle using objective Kinovea 2D software
Time frame: 3 months
Lumbo-Sacral Angle using objective Kinovea 2D software
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals, run by Cairo University at 2 sites in Egypt.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Salah Sawan, Bachelor's degree (+201144047770, abdelrahman.sawan@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity (Maximum amplitude in microvolt) - Electromyography Device Using interference pattern (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.