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临床试验/NCT04325516
NCT04325516Unknown不适用

Decoding Motion Planning Using Cortical Potentials in People With a Transfemoral Amputation and Able-bodied Individuals

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
ElectroMyography activity in milliseconds

研究概览

简要总结

The team will investigate the user's intention to move by using cortical activity during a sit to stand movement performance in people with a transfemoral amputation and able-bodied individuals. The goal is to get insights in pre-movement onset indicators within the brain that initiate the sit to stand transfer. The hypothesis is that people with a transfemoral amputation use different brain locations for motion planning compared to able-bodied individuals.

详细描述

The evolution of lower limb prostheses has made considerable progress in the past decades. There has been a transition from passive (e.g. Total knee®, Össur) to quasi-passive (e.g. C-leg®, Otto Bock) and eventually to active prostheses (e.g. Power knee®, Össur). The development always focused on an amputation as a primary peripheral disorder. For example, manufacturers have been searching to compensate the loss of muscle mass by adding torque into the prosthesis. However, few considerations have yet been taken to the fact that central adaptations are also observed after amputation in terms of neuroplasticity and reorganization.

The atypical motion planning strategies of people with a lower limb amputation (LLA) could possibly be related to the challenges that they experience during daily activities, such as the sit to stand transfer. Standing up from a chair is a relevant clinical problem and current devices do not yet relieve the asymmetrical loading. A few studies have already investigated the muscular activity during a sit to stand movement in people with a LLA and able-bodied individuals. The movement is characterized by a forward displacement of the centre of mass with the highest activation of the m. gluteus maximus, m. adductor magnus and m. biceps femoris.The sit to stand transfer is a potential movement to investigate brain activity incorporating the advantages and disadvantages of EEG measurements.

Until now, the development of lower limb prostheses approaches people with a LLA as a peripheral disorder whereas relevant central adaptations are also observed. Therefore, the purpose of this study is to identify the cortical activity that is responsible for successfully completing a sit to stand transfer. The hypothesis is that different brain locations are activated in people with a transfemoral amputation for motion planning compared to able-bodied individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: 25 - 75 years
  • •Gender: men and women
  • •Level of amputation: unilateral transfemoral
  • •Vascular or traumatic cause of amputation
  • •Medicare Functional Classification Level25: K3-4
  • •Participants are able to stand up from a chair and return to the seated position without support of their hands for ten repetitions
  • •Participants wear their prosthesis for at least 8 hours/day (Prosthetic use has been shown to have an influence on functional reorganization)
  • •No cognitive impairment. This will be objectified with the mini-mental state examination (score on 30)

排除标准

  • •Any neurological disease
  • •No upper limb or bilateral amputation

研究组 & 干预措施

People with a lower limb amputation

Experimental

Participants will perform four tasks in a randomized order:

  • sit to stand
  • dorsi flexion of the foot
  • knee extension
  • hip extension

干预措施: Daily activities (Behavioral)

Able bodied individuals

Experimental

Participants will perform four tasks in a randomized order:

  • sit to stand
  • dorsi flexion of the foot
  • knee extension
  • hip extension

干预措施: Daily activities (Behavioral)

结局指标

主要结局

ElectroMyography activity in milliseconds

时间窗: Approximatley 9 months

Amplitude

ElectroEncephalography in milliseconds

时间窗: Approximatley 9 months

Movement related cortical potential before the actual movement

ElectroMyography timing

时间窗: Approximatley 9 months

Time of movement onset

次要结局

  • Duration of the sit to stand test(Approximatley 9 months)

研究者

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

Jo Ghillebert

Principle Investigator

Vrije Universiteit Brussel

研究点 (1)

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