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Reciprocating Gait Orthoses for Paraplegia Patients (UPGO)

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ClinicalTrials.gov Identifier: NCT02227407
Recruitment Status : Unknown
Verified August 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Ambulation would bring many physiological and psychological benefits and getting up and walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for paraplegics particularly draws research attentions because it mimics human gait pattern.But, the high energy consumption and low walking speeds caused the frequent abandonment or the low utilization of the reciprocating gait orthoses.To improve the design reducing the energy expenditure, it requires biomechanical analysis of the pathological gait such that the gait deviations and energy consuming mechanisms can be identified and remedial means can be implemented.

The investigators hypotheses will include that there would exist an energy saving mechanism of human reciprocating locomotion based on the principle of conservation of mechanical energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy saving mechanism. Finally, the control of knee joint coordinating with the hip joint movements would facilitate the gait progression and further reduce the energy consumption.

The objective of this clinical trial is to evaluate the gait of paraplegic patients with reciprocating gait orthoses and to support the investigators research in biomechanical analysis, design and control of reciprocating gait orthoses for paraplegia patients. An experiment to study the pathological gait of paraplegia patients with an existing reciprocating gait orthosis will be carried out.


Condition or disease Intervention/treatment Phase
Myelomeningocele Spinal Cord Injury Spinal Muscular Atrophy Device: RGOs(reciprocating gait orthoses) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: NSC Assistive Technology Research: Reciprocating Gait Orthoses for Paraplegia Patients
Study Start Date : August 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: Energy expenditure, gait pattern, RGOs
using motion capture system and forceplates to monitor gait pattern while wearing reciprocating gait orthoses to calculate the mechanical energy cost
Device: RGOs(reciprocating gait orthoses)
using additional apparatus combined with Hip-Knee-Ankle-Foot orthoses (HKAFO) to help paraplegia patients to present reciprocating gait pattern
Other Name: other name:HKAFO(Hip-Knee-Ankle-Foot orthoses)




Primary Outcome Measures :
  1. the difference of joint kinetic data in able-bodied subjects and RGO users [ Time Frame: baseline, 30 minutes after fitting of the RGOs ]
    joint force, joint moment and joint power during gait


Secondary Outcome Measures :
  1. the difference of gait parameter in able-bodied subjects and RGO users [ Time Frame: baseline, 30 minutes after fitting of the RGOs ]
    stride length, gait cycle period, gait speed

  2. the difference of joint kinematic data in able-bodies subjects and RGO users [ Time Frame: baseline, 30 minutes after fitting of the RGOs ]
    joint angle, joint excursion, joint angular velocity and acceleration


Other Outcome Measures:
  1. the difference of energy flow in able-bodied subjects and RGO users [ Time Frame: baseline, 30 minutes after fitting of the RGOs ]
    measurement of the joint and segmental mechanical energy transfer during gait while using orthoses



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • myelomeningocele or spinal cord injured patients at neurological level of T10-L2).
  • they should be walking with RGO for at least 30 meters (assistant device if needed).

Exclusion Criteria:

  • spasticity, contractures, and recurrent lower limb injuries
  • other neuromuscular disease
  • insufficient walking ability

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): NCT02227407


Contacts
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Contact: Liang-Wey Chang, Ph.D +886-2-3366-3298 bmechlw@ntu.edu.tw
Contact: Sheng-Ming Huang, Master +886-2-3365-3368 ext 101 odrow.lin@msa.hinet.net

Locations
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Taiwan
Rehabilitation Engineering Research Center Recruiting
Taipei, Taiwan
Contact: Liang-Wey Chang, P.h.D.    +886-2-3366-3298    bmechlw@ntu.edu.tw   
Contact: Sheng-Ming Huang, master    +886-910-947-955    odrow.lin@msa.hinet.net   
Principal Investigator: Liang-Wey Chang, P.h.D.         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: Liang-Wey Chang, Ph.D. Rehabilitation Engineering Lab,NTU

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02227407     History of Changes
Other Study ID Numbers: 201305047RINC
200703061R ( Other Identifier: NTUHREC )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by National Taiwan University Hospital:
SCI
SMA
Paralysis
Additional relevant MeSH terms:
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Spinal Cord Injuries
Muscular Atrophy
Muscular Atrophy, Spinal
Paraplegia
Meningomyelocele
Spina Bifida Cystica
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases
Paralysis
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism