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

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ClinicalTrials.gov Identifier: NCT02793973
Recruitment Status : Unknown
Verified January 2016 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.


Condition or disease Intervention/treatment Phase
Leg Length Discrepancy, Shoe Lifts Device: shoe lifts Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 80% discrepancy lift height correction
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.
Device: shoe lifts
Experimental: optimal lift height correction
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.
Device: shoe lifts



Primary Outcome Measures :
  1. Visual analogue scale, VAS [ Time Frame: Changes from baseline in VAS for six month continually ]

    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 :
  1. Degree of comfort [ Time Frame: Changes from baseline in comfort scale for six month continually ]
    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.

  2. areas of pain (cm^2) [ Time Frame: Changes from baseline in areas of pain one time per week for six month ]
    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.

  3. spatio-temporal parameters of gait [ Time Frame: Changes from baseline in spatio-temporal parameters of gait after intervention immediately and at 4, 8, 12, 24 weeks ]
    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.

  4. three dimensional changing joint angles 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 ]
    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.

  5. muscle activity [ Time Frame: Changes from baseline in muscle activity after intervention immediately and at 4, 8, 12, 24 weeks ]
    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.

  6. plantar force (kgw) [ Time Frame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks ]
    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.

  7. plantar pressure (kgw/cm^2) [ Time Frame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks ]
    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.

  8. contact area (cm^2) [ Time Frame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks ]
    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.

  9. Energy expenditure (Joule) [ Time Frame: Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793973


Contacts
Contact: Chen Hsin Lu 886+2+28712121 ext 2931 corniculatastar@gmail.com

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Si Huei Lee Taipei Veterans General Hospital, Taiwan

Additional Information:
Publications:
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02793973     History of Changes
Other Study ID Numbers: 2016-01-011A
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Leg Length Inequality
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical