The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients

Study Overview
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Brief Summary
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A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has been estimated at 40-70%. Those who have been suffered from limping for a long time may lead to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb triple view of x-ray is considered to be the current technique for determining LLD, it is costly and time consuming that not every hospital can afford it, and in case of radiograph, the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical assessment method by gathering exterior parameters to build up a Regression model for measuring the discrepancy and determining LLD accurately. While using shoe lifts to correct discrepancy is the easiest conservative intervention for LLD, there are still many controversies on how much height should be added clinically and academically. The optimal height should be added depends on feedbacks from users and gait performance. The best gait performance can be measured from kinematic performance of center mass of body during walking. Therefore, this project wants to compare treatment responses between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in shoe lift height correction through triple view of x-ray and given optimal shoe lift height correction through analyzing kinematic performance of center mass of body.

Conditions
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Leg Length Discrepancy, Shoe Lifts

Intervention / Treatment
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* Device: shoe lifts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 20 to 70 being able to walk independently being diagnosed with congenital SLLD or not willing to cooperate to wear shoe lifts has smart phone and willing to record information that investigators need willing to sign agreement Exclusion Criteria: neurological diseases (i.e. Parkinson's disease, CVA, Polio, and lower limb nerve injuries, etc.) diabetes along with peripheral neuropathy history of lower limb fracture injury or joint replacement leading to uneven leg length osteoporosis along with compression fracture foot, ankle, or knee joint deformity, osteoarthritis or soft tissue pain that disturb gait performance (ex. degenerative osteoarthritis, plantar fasciitis, and etc.) pregnancy idiopathic scoliosis history of psychological disease or drug addiction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 80% discrepancy lift height correction<br>Each participant will be given 80% discrepancy shoe lift height correction through analyzing kinematic performance of center mass of body and will be required to wear the lifts in their shoes when they are walking or standing for 6 month. | Device: shoe lifts<br> <br> |
| Experimental: optimal lift height correction<br>Each participant will be given the optimal shoe lift height correction through analyzing kinematic performance of center mass of body and will be required to wear the lifts in their shoes when they are walking or standing for 6 month. | Device: shoe lifts<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale, VAS | Pain fields of every participant in two groups will be recorded by APP every day for six month continually. The pain fields include：bilateral cervical, trunk, upper limb, lower limb, and foot regions, totally 10 regions. The score of each region is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The total score may range from 0-1000. | Changes from baseline in VAS for six month continually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of comfort | Degree of comfort at foot site in two groups will be recorded by APP every day for six month continually. The score ranges from 0-10. A higher score indicates greater comfort. | Changes from baseline in comfort scale for six month continually | 
| areas of pain (cm^2) | Areas of pain in two groups will be calculated and recorded by APP. The pain fields include：bilateral cervical, trunk, upper limb, lower limb, and foot regions, totally 10 regions. The APP will give participants figures of every region. Each region will be filled with grids. Participants need to select specific grids, according to how many areas pain covers. | Changes from baseline in areas of pain one time per week for six month | 
| spatio-temporal parameters of gait | GAITRite Walkway, CIR Systems, Havertown, PA, USA. The GaitRITE system was developed in response to the need for an objective way to quantify gait and ambulatory status. The GAITRite System measures spatio-temporal parameters of gait such as cadence, step length, step width, velocity, and toe-out angle, providing clinically relevant information that is useful in devising treatment plans and evaluating treatment outcomes. The system tracks parameters over time and can be used to generate progress and status reports. | Changes from baseline in spatio-temporal parameters of gait after intervention immediately and at 4, 8, 12, 24 weeks | 
| three dimensional changing joint angles and trunk sway during walking | myoMOTION, Noraxon USA Inc., Scottsdale, AZ, USA. Wireless and portable 3D Kinematic System reveals what's unnoticeable to the naked eye, from small angular displacements to major movement pattern compensations. It contains 13 sensors fixed at bilateral dorsal side of foot, anterior medial side of tibia, lower quadrant of quadriceps, T12/L1, C7, lateral and longitudinal side of upper arm below the trapezius muscle belly, distal part of forearm and sacrum for measuring three dimensional joint angles between two segments and trunk sway during walking. | Changes from baseline in three dimensional joint angles between two segments and trunk sway during walking after intervention immediately and at 4, 8, 12, 24 week | 
| muscle activity | Free EMG 300, BTS Bioengineering, Milan, Italy. BTS FREEEMG 300A is a wireless synchromyography device for dynamic muscular activity analysis. It contains eight channels for detecting muscle activity, including bilateral gluteus medius, vastus lateralis, plantar flexor, and anterior tibialis. | Changes from baseline in muscle activity after intervention immediately and at 4, 8, 12, 24 weeks | 
| plantar force (kgw) | wireless F-Scan, Tekscan Inc., Boston, MA, USA. The F-Scan system provides dynamic pressure, force and timing information for foot function and gait analysis. Its pressure sensing film will be put between feet and shoe lifts to measureheel, medial forefoot, metatarsal head and hallux plantar force. The more even value of both sides indicates the better correction. | Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks | 
| plantar pressure (kgw/cm^2) | wireless F-Scan, Tekscan Inc., Boston, MA, USA. The F-Scan system provides dynamic pressure, force and timing information for foot function and gait analysis. Its pressure sensing film will be put between feet and shoe lifts to measure heel, medial forefoot, metatarsal head and hallux plantar pressure.The more even value of both sides indicates the better correction. | Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks | 
| contact area (cm^2) | wireless F-Scan, Tekscan Inc., Boston, MA, USA. The F-Scan system provides dynamic pressure, force and timing information for foot function and gait analysis. Its pressure sensing film will be put between feet and shoe lifts to measure contact area of region of interest. The value will be further calculated for determining whether the foot pronation/supination has been corrected. | Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks | 
| Energy expenditure (Joule) | iPod Touch, Apple Inc., Cupertino, CA, USA. It will be fixed at lumbar-sacrum junction to measure three-dimensional instantaneous linear acceleration of center mass of body, and further to analyze kinematic performance by calculating three dimensional thrust power and thrust energy. The less energy expends, the better kinematic performance of center mass of body displays. | Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks |