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

Taipei Veterans General Hospital

Status: Unknown

Conditions: Leg Length Discrepancy, Shoe Lifts

Treatments: Device: shoe lifts

Study type: Interventional

Funder types: Other

Identifiers

NCT02793973

2016-01-011A

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

80% discrepancy lift height correction

Active Comparator group

Description:

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.

Treatment:

Device: shoe lifts

optimal lift height correction

Experimental group

Description:

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.

Treatment:

Device: shoe lifts