跳至主要内容
临床试验/NCT04635436
NCT04635436招募中不适用

Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Ankle Joint Power

研究概览

简要总结

Walking on a split-belt treadmill (each of the two belts running at a different speed) imposes an asymmetrical gait, mimicking limping that has been observed in various pathologic conditions. This walking modality has been proposed as an experimental paradigm to investigate the flexibility of the neural control of gait and as a form of therapeutic exercise for hemi-paretic patients. However, the scarcity of dynamic investigations both for segmental aspects and for the entire body system, represented by the centre of mass, challenges the validity of the available findings on split gait.

Compared with overground gait in hemiplegia, split gait entails an opposite spatial and dynamic asymmetry. The faster leg mimics the paretic limb temporally, but the unimpaired limb from the spatial and dynamic point of view. These differences suggest that a partial shift in perspective may help to clarify the potential of the split gait as a rehabilitation tool.

The aim of the present study is to investigate the dynamic asymmetries of lower limbs in adults with unilateral motor impairments (e.g. hemiplegia post-stroke, Parkinson's disease, multiple sclerosis, unilateral amputation, surgical orthopedic interventions) during adaptation to gait on a split-belt treadmill. The sagittal power provided by the ankle and the total mechanical energy of the centre of mass will be thoroughly studied. The time course of phenomena both during gait when the belts are running at different speed and when the belts are set back to the same speed (i.e. the after-effect) will be investigated.

A greater dynamic symmetry between the lower limbs is expected after split gait. The question whether this symmetry will occur when the pathological limb is on the faster or the lower belt will be disclosed. Some alterations of the motion of the centre of mass during split gait are also expected.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age between 18 and 70 years old;
  • •ability to walk for at least 20 meters without support;
  • •ability to wittingly sign the informed consent form;
  • •ability to understand the instructions and to complete the motor task;
  • •visual acuity > 10/20 on the worse side, with optical correction;
  • •unilateral motor impairments of one lower limb as a consequence of various pathologic conditions, such as (not exhausting list): post-stroke hemiparesis, Parkinson's disease with lateral asymmetry in the motor symptoms, multiple sclerosis with lateral asymmetry in the motor symptoms, unilateral amputation with prosthetic correction, surgical orthopedic interventions, unilateral lesions of peripheral nerves.

排除标准

  • •systemic neurologic pathologies;
  • •orthopedic surgical interventions, other than those determining the inclusion criteria;
  • •symptomatic pathologies of rachis;
  • •other sensory or neurological pathologies with impact on balance and gait;
  • •pregnancy.

研究组 & 干预措施

Pathologic group

Other

At least 20 participants with various orthopaedic or neurologic conditions (for example, post-stroke hemiparesis, Parkinson's disease, multiple sclerosis, unilateral amputation, surgical orthopedic interventions) will be enrolled.

干预措施: Split-belt treadmill walking. (Other)

结局指标

主要结局

Ankle Joint Power

时间窗: Two assessments, at one week-interval

Joint kinematics will be recorded through an optoelectronic method as per the Davis anthropometric model. The 3D displacement of the markers will be captured using 10 near-infrared stroboscopic cameras. Joint power will be computed through the spatiotemporal synchronization of ground reaction force vectors and the joint centers of rotation. Only the sagittal plane will be considered for the analysis. Joint power will be computed as the product of joint torque and joint rotation speed. Power will be defined as positive or generated when the joint moment and rotation speed shared the same directions (i. e., when agonist muscles are contracting while shortening), as negative or absorbed otherwise. Positive work will be computed as the integral of the generated (positive) power over time.

次要结局

  • Step Length(Two assessments, at one week-interval)
  • Single Stance Time(Two assessments, at one week-interval)
  • Parameters of the center of mass motion(Two assessments, at one week-interval)
  • Double Stance Time(Two assessments, at one week-interval)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Tesio, Prof

MD, Director of the Department of Neuromotor Rehabilitation, Ospedale San Luca, Istituto Auxologico Italiano, IRCCS; Full Professor, Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy

Istituto Auxologico Italiano

研究点 (1)

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