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临床试验/NCT02227407
NCT02227407Unknown不适用

NSC Assistive Technology Research: Reciprocating Gait Orthoses for Paraplegia Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
8
试验地点
1
主要终点
the difference of joint kinetic data in able-bodied subjects and RGO users

研究概览

简要总结

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.

详细描述

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 patients to ambulate in an upright position without the use of crutches or other walking aids. Patients progress by shifting the center of gravity; and increase the walking speed by swing their arms and by the rotation of the trunk. Loretta et al. compared the swivel gait with the swing gait, which shows the swivel gait has slower speed but more efficient gait which implies that lower metabolic cost and oxygen consumption are needed. Although the swivel walker has the advantages of providing low energy and hand-free walking, it was most criticized for its low walking speed and for its inability to ambulate on an uneven surface. The third one is a group of reciprocating gait orthoses which were developed with a belief that they would provide a more energy efficient gait than other gait orthoses. The LSU RGOs developed in the early 1980's has hip joints that are linked to act in a reciprocal pattern. In the early 1990s, there were two revised version of the LSU RGOs developed, ARGOs (Advanced RGOs using one cable and IRGOs (Isocentric RGOs) using a solid rocker bar. The hip guidance orthosis (HGOs) that provides friction-free hip joint also allows patients to walk reciprocally. WO, walkabout orthosis, is an infraperineal structure that also facilitates reciprocating walking. Comparing with HKAFO, RGOs was heavier, slower, and the energy cost (mL/kg/m) was higher although the energy consumption rate (mL/kg/min) was significantly higher for children in HKAFOs.

To achieve an efficient gait and to overcome the problem to be slow, the hybrid system, that is the combination of the FES and RGOs , had shown the possibility for improvement. Because this system used both the RGOs structural stability and muscle power stimulated by FES to decrease the activity of the trunk muscles in prevention from fatigue, it can provide more energy-efficient gait that increases the aerobic-anaerobic threshold of the patients in the long term.

Many orthotic options for paraplegia are available but only to provide limited walking functions with great energy consumption, which has been the reason for the frequent abandonment or the low utilization of the RGOs. 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. There has been a recent research on the biomechanical analysis of an ARGOs user's gait and some possible mechanisms contributing to the high energy consumption were discussed. However, no further remedial action in terms of design parameters was suggested in their work. It is obvious that more research on the biomechanical study are needed to advance the development of orthotic solutions for paraplegia patients.

Gait determinants were to identify the sources which affect the energy expenditure. The determinants include pelvic rotation, pelvic list, knee flexion at mid-stance, foot and ankle motion, knee motion and lateral pelvic displacement. There were studies to evaluate the effects of these kinematic gait determinants on reduction of the vertical displacement of the Body Center of mass (BCOM). Gard and Childress found that the magnitude of the trunk's vertical excursion was virtually unaffected by pelvic list. Kerrigan pointed out the there are other primary gait determinants needed to explain the actual reduction in BCOM vertical displacement. A reduction of BCOM vertical excursion may have significant energy implications, but it requires kinetic consideration to prove the gait determinants do affect the energy expenditure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

Energy expenditure, gait pattern, RGOs

Experimental

using motion capture system and forceplates to monitor gait pattern while wearing reciprocating gait orthoses to calculate the mechanical energy cost

干预措施: RGOs(reciprocating gait orthoses) (Device)

结局指标

主要结局

the difference of joint kinetic data in able-bodied subjects and RGO users

时间窗: baseline, 30 minutes after fitting of the RGOs

joint force, joint moment and joint power during gait

次要结局

  • the difference of gait parameter in able-bodied subjects and RGO users(baseline, 30 minutes after fitting of the RGOs)
  • the difference of joint kinematic data in able-bodies subjects and RGO users(baseline, 30 minutes after fitting of the RGOs)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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