Clinical Trial: Reciprocating Gait Orthoses for Paraplegia Patients

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: NSC Assistive Technology Research: Reciprocating Gait Orthoses for Paraplegia Patients

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.


Detailed Summary:

Background: Ambulation is a rehabilitation priority for many paraplegic patients, either for the psychological reasons or with the aim to achieve partial or full independence. It also provides the therapeutic benefits which are widely acknowledged to improve urinary drainage, to improve peripheral circulation, and to prevent the complication caused from bedridden, such as contracture, osteoporosis, urinary tract infection, and constipation etc. Some studies also found that ambulation will increase cardiopulmonary function. For those pediatric spinal cord-injured patients, the upright posture also profits the development of trunk and head control. There are a number of reciprocating gait orthoses (RGOs) available in practice for paraplegics, the problems of which have been slow, heavy and high energy-consumption. The biomechanical causes are not fully understood. Despite all the benefits that RGOs can offer, research and clinical experience indicated that most paraplegia patients choose wheelchair mobility after discharge to the community because it is faster, safer and needs less energy expenditure. Therefore, a biomechanical study of the pathological gait of paraplegia patients with RGOs is critically needed. The problems of currently applied RGOs need to be analyzed and remedial means to be proposed. In addition, a new RGOs system is also needed to serve as a research tool and a platform proving the remedial ideas.

Literature Review: There are many kinds of gait orthoses prescribed for paraplegics, which can be grouped according to the patterns of propulsion. The first type is a group of swing-through gait orthoses which include the Knee-Ankle-Foot orthoses (KAFO), Hip-Knee-Ankle-Foot orthoses (HKAFO), and the parapodium. The swing-through gait has high energy cost and users give up the orthoses easily. Swivel walkers belong to the second group, which enables paraplegic
Sponsor: National Taiwan University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: April 11, 2014
Date Started: August 2013
Date Completion: January 2016
Last Updated: August 26, 2014
Last Verified: August 2014