Leg Length Discrepancy, Shoe Lifts Clinical Trial
| NCT number | NCT02793973 |
| Other study ID # | 2016-01-011A |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | April 1, 2016 |
| Last updated | June 2, 2016 |
| Start date | May 2016 |
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Taipei Veterans General Hospital, Taiwan |
Baylis WJ, Rzonca EC. Functional and structural limb length discrepancies: evaluation and treatment. Clin Podiatr Med Surg. 1988 Jul;5(3):509-20. Review. — View Citation
Bhave A, Paley D, Herzenberg JE. Improvement in gait parameters after lengthening for the treatment of limb-length discrepancy. J Bone Joint Surg Am. 1999 Apr;81(4):529-34. — View Citation
Blake RL, Ferguson HJ. Correlation between limb length discrepancy and asymmetrical rearfoot position. J Am Podiatr Med Assoc. 1993 Nov;83(11):625-33. — View Citation
D'Amico JC, Dinowitz HD, Polchaninoff M. Limb length discrepancy. An electrodynographic analysis. J Am Podiatr Med Assoc. 1985 Dec;75(12):639-43. — View Citation
DENSLOW JS, CHACE JA. Mechanical stresses in the human lumbar spine and pelvis. J Am Osteopath Assoc. 1962 May;61:705-12. — View Citation
Greenman PE. Lift therapy: use and abuse. J Am Osteopath Assoc. 1979 Dec;79(4):238-50. — View Citation
Hoffman KS, Hoffman LL. Effects of adding sacral base leveling to osteopathic manipulative treatment of back pain: a pilot study. J Am Osteopath Assoc. 1994 Mar;94(3):217-20, 223-6. — View Citation
NELSON CR. Postural analysis and its relation to systemic disease. J Am Osteopath Assoc. 1948 Jul;47(11):555-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |