Completed

The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

shoe lift

Other
Who is being recruted

Congenital Abnormalities+18

+ Talipes

+ Back Pain

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2010
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2010

Actual date on which the first participant was enrolled.

People with anatomical leg length discrepancy (LLD) commonly presented excessive subtalar pronation of the long leg compared to their short leg in order to equalize leg length. Although such compensation may decrease the stress in the pelvis and/or low back region, the pronated foot may lead to excessive stress loading onto the ankle or foot, resulting in musculoskeletal injuries. Clinically, the pronated foot has been effectively controlled using functional orthoses with proper posting by adjusting the subtalar joint in the neutral position. But for people with compensatory pronated foot resulted from anatomical LLD, to control excessive pronation of the long leg would exaggerate their asymmetry in leg length. Instead, the pronated foot can be controlled simply by adjusting the length of the short leg. However, there is limited evidence of such intervention in previous literature. The purpose of this research project is going to determine the effect of leg length adjustment on pronation control in people with anatomical LLD. According to this purpose, 5 study objectives will be developed: 1) to examine the validity and reliability of LLD measurement using a hand-held laser distance meter, 2) to compare the foot types before and after leg length adjustment, 3) to compare the kinetic variables before and after leg length adjustment during quiet stance, 4) to compare the kinetic variables before and after leg length adjustment during level walking, and 5) to compare symptoms and functional levels related to low back pain (LBP) before and after leg length adjustment. The present research project will be designed as a convenience sampling, prospective, quasi-experimental, and pretest/posttest design. There will be 2 parts in this research: 1) validity and reliability test of laser measure for leg length and 2) foot morphology and kinetic analysis before and after leg length adjustment. For the first part of this research, 10 male adults and 20 adults will be recruited for the validity and reliability tests respectively. Anthropometric measurements, including body height, body weight, foot length, foot width, and heel-ball distance, will be measured after a consent form is signed. Participants of the validity test will receive standing pelvic radiography and laser measure to measure their leg length. Each participant of the reliability test will receive 2 sessions of laser measure using a hand-held laser-distance meter. For the first session, all laser measurements will be employed twice by 2 raters with a rest interval of more than 5 min. One week later, another session of laser measure will be given again by one of these 2 raters. Intraclass correlation coefficient (ICC) will be used to test the interrater reliability, intrarater reliability, and validity of the laser measure method. Standard error of measurement (SEM), and small real difference (SRD) will be calculated to represented intrarater reliability also. For the second part of the research, another thirty adults with compensatory pronated foot resulted from LLD will be included in the research project but the sample size will be adjusted to the appropriate number according to power analysis. Each participant will be asked to fill out the visual analog scale (VAS) and the Oswestry Disability Index (ODI) and receive tests containing foot type examination, quiet stance with eye opening, quiet stance with eye closed, and level walking. All tests will be performed before and after leg length adjustment. The experiment will be completed after collecting 3 successful trials for each test. All procedures will be done one month later. ANOVA with repeated measures will be calculated to compare the differences in these variables among before, immediately after, and 1 month following leg length adjustment when the data fit the assumptions of normal distribution. Discrete variables or variables with non-normal distribution were tested using the Friedman test. All statistical analyses will be calculated using SAS 9.1.3. The significant level was set at α = 0.05 while the power was at 0.8. Five possible results may be expected from conducting this research project: 1) there will be good validity and reliability of the laser distance meter to measure LLD, 2) there will be significant differences in measurements of foot type before and after leg length adjustment, 3) there will be significant differences in kinetic data during quiet stance before and after leg length adjustment, 4) there will be significant differences in kinetic data during level walking before and after leg length adjustment, and 5) symptom and functional level related to LBP will improve after leg length adjustment. Completion of this research project will be projected to provide solid and objective evidences for leg length adjustment through views of morphology and kinetics in people with pronated foot due to anatomical LLD.

Official TitleThe Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy
NCT01187693
Principal SponsorNational Taiwan University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesTalipesBack PainBone DiseasesBone Diseases, DevelopmentalFlatfootFoot DeformitiesFoot Deformities, AcquiredFoot Deformities, CongenitalLeg Length InequalityMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back PainLimb Deformities, CongenitalPathological Conditions, AnatomicalLower Extremity Deformities, Congenital

Criteria

3 inclusion criteria required to participate
Leg length discrepancy between 0.5~2 cm

Chronic low back pain

Pronated foot of the longer leg (the magnitude of pronation should be more of the longer leg than of the short)

13 exclusion criteria prevent from participating
History of operation in low back, pelvis, and lower extremities

Severe deformity of lower extremities

Sacroiliac dysfunction

Symptoms or diseases of neural system

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

School and Graduate Institute of Physical Therapy National Taiwan University

Taipei, TaiwanOpen School and Graduate Institute of Physical Therapy National Taiwan University in Google Maps
CompletedOne Study Center