Spinal Cord Injury Clinical Trial
— UPGOOfficial title:
NSC Assistive Technology Research: Reciprocating Gait Orthoses for Paraplegia Patients
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.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Rehabilitation Engineering Research Center | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | the difference of energy flow in able-bodied subjects and RGO users | measurement of the joint and segmental mechanical energy transfer during gait while using orthoses | baseline, 30 minutes after fitting of the RGOs | Yes |
Primary | the difference of joint kinetic data in able-bodied subjects and RGO users | joint force, joint moment and joint power during gait | baseline, 30 minutes after fitting of the RGOs | Yes |
Secondary | the difference of gait parameter in able-bodied subjects and RGO users | stride length, gait cycle period, gait speed | baseline, 30 minutes after fitting of the RGOs | Yes |
Secondary | the difference of joint kinematic data in able-bodies subjects and RGO users | joint angle, joint excursion, joint angular velocity and acceleration | baseline, 30 minutes after fitting of the RGOs | Yes |
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