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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
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Length Discrepancy, Shoe Lifts

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

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

    First Posted
    April 1, 2016
    Last Updated
    June 2, 2016
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    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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