Clinical trial NCT02793973: The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Length Discrepancy, Shoe Lifts
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale, VAS
timeFrame: Changes from baseline in VAS for six month continually
Secondary outcomes:
measure: Degree of comfort
timeFrame: Changes from baseline in comfort scale for six month continually
measure: areas of pain (cm^2)
timeFrame: Changes from baseline in areas of pain one time per week for six month
measure: spatio-temporal parameters of gait
timeFrame: Changes from baseline in spatio-temporal parameters of gait after intervention immediately and at 4, 8, 12, 24 weeks
measure: three dimensional changing joint angles and trunk sway during walking
timeFrame: 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
measure: muscle activity
timeFrame: Changes from baseline in muscle activity after intervention immediately and at 4, 8, 12, 24 weeks
measure: plantar force (kgw)
timeFrame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
measure: plantar pressure (kgw/cm^2)
timeFrame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
measure: contact area (cm^2)
timeFrame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
measure: Energy expenditure (Joule)
timeFrame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Si Huei Lee
role: PRINCIPAL_INVESTIGATOR
References:
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