The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients
Primary Purpose
Leg Length Discrepancy, Shoe Lifts
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
shoe lifts
Sponsored by
About this trial
This is an interventional treatment trial for Leg Length Discrepancy, Shoe Lifts
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
80% discrepancy lift height correction
optimal lift height correction
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02793973
First Posted
April 1, 2016
Last Updated
June 2, 2016
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02793973
Brief Title
The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Discrepancy, Shoe Lifts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
80% discrepancy lift height correction
Arm Type
Active Comparator
Arm 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.
Arm Title
optimal lift height correction
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
shoe lifts
Primary Outcome Measure Information:
Title
Visual analogue scale, VAS
Description
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.
Time Frame
Changes from baseline in VAS for six month continually
Secondary Outcome Measure Information:
Title
Degree of comfort
Description
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.
Time Frame
Changes from baseline in comfort scale for six month continually
Title
areas of pain (cm^2)
Description
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.
Time Frame
Changes from baseline in areas of pain one time per week for six month
Title
spatio-temporal parameters of gait
Description
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.
Time Frame
Changes from baseline in spatio-temporal parameters of gait after intervention immediately and at 4, 8, 12, 24 weeks
Title
three dimensional changing joint angles and trunk sway during walking
Description
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.
Time Frame
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
Title
muscle activity
Description
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.
Time Frame
Changes from baseline in muscle activity after intervention immediately and at 4, 8, 12, 24 weeks
Title
plantar force (kgw)
Description
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.
Time Frame
Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
Title
plantar pressure (kgw/cm^2)
Description
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.
Time Frame
Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
Title
contact area (cm^2)
Description
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.
Time Frame
Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
Title
Energy expenditure (Joule)
Description
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.
Time Frame
Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Hsin Lu
Phone
886+2+28712121
Ext
2931
Email
corniculatastar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Si Huei Lee
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
13885486
Citation
DENSLOW JS, CHACE JA. Mechanical stresses in the human lumbar spine and pelvis. J Am Osteopath Assoc. 1962 May;61:705-12. No abstract available.
Results Reference
background
PubMed Identifier
18872347
Citation
NELSON CR. Postural analysis and its relation to systemic disease. J Am Osteopath Assoc. 1948 Jul;47(11):555-8. No abstract available.
Results Reference
background
PubMed Identifier
159883
Citation
Greenman PE. Lift therapy: use and abuse. J Am Osteopath Assoc. 1979 Dec;79(4):238-50. No abstract available.
Results Reference
background
PubMed Identifier
8200825
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.
Results Reference
background
PubMed Identifier
3293752
Citation
Baylis WJ, Rzonca EC. Functional and structural limb length discrepancies: evaluation and treatment. Clin Podiatr Med Surg. 1988 Jul;5(3):509-20.
Results Reference
background
PubMed Identifier
8258774
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. doi: 10.7547/87507315-83-11-625.
Results Reference
background
PubMed Identifier
10225798
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. doi: 10.2106/00004623-199904000-00010.
Results Reference
background
PubMed Identifier
4078719
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. doi: 10.7547/87507315-75-12-639. No abstract available.
Results Reference
background
Links:
URL
https://goo.gl/kwqmsn
Description
Related Info
URL
https://goo.gl/bESN84
Description
Related Info
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The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients
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