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临床试验/NCT06250478
NCT06250478已完成不适用

Het Gebruik Van Dynamische Echografie om Spier-pees Veranderingen te Onderzoeken in de Kuitspieren Van Personen na Een CVA: Een Pilootstudie

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Tendon dynamics measured with ultrasound during walking

研究概览

简要总结

Muscle behaviour of calf muscles can be studied during dynamic conditions using dynamic ultrasound. In particular, the medial gastrocnemius is suitable for measurements with dynamic ultrasound due to its superficial location. With this measurement technique, the muscle behavior during walking can be observed gaining insight into the mechanism of action of this muscle during a functional task. This technique has already been used in other populations (such as children with cerebral palsy) but not yet in individuals after a stroke.

Therefore, the aim of this study is to assess the muscle behavior of the medial gastrocnemius during walking in persons after stroke. There are 3 concrete objectives of the current study:

  1. is the technique feasible to perform in persons after stroke?
  2. does the use of the dynamic echoprobe change gait patterns?
  3. can differences between persons after stroke and healthy controls be detected? This data can be used as pilot data for project applications in the future that will allow to design larger studies.

Therefore, 10 stroke patients and 10 age- and gender-matched healthy controls will walk on a treadmill for 3x2 minutes after a familiarisation period of 6 minutes.

During 1 x 2 minutes, subjects will walk without using the dynamic ultrasound. This recording aims to measure the normal gait pattern of the subjects.

During the other 2x2 minutes, subjects will walk using the dynamic ultrasound at 2 different locations on the calf. Once with the ultrasound probe on the centre of the muscle belly to visualise muscle fibre bundles and once on the muscle tendon transition, from which muscle belly and tendon length can be derived.

The use of ultrasound or not will be randomized to exclude the effect of fatigue on the outcome measures.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Stroke group Inclusion criteria
  • •stroke adults
  • •no other neurologic conditions
  • •ability to walk independently on a treadmill

排除标准

  • •wearing ankle foot orthosis that inhibit the assessment
  • •had lower limb surgery in the past
  • •Healthy volunteers Inclusion criteria
  • •- healthy adults
  • •Exclusion criteria
  • •suffering from any neurological condition
  • •had lower limb surgery in the past

研究组 & 干预措施

Healthy controls

Active Comparator

干预措施: Dynamic ultrasound of the calf muscles (Diagnostic Test)

Stroke patient

Experimental

干预措施: Dynamic ultrasound of the calf muscles (Diagnostic Test)

结局指标

主要结局

Tendon dynamics measured with ultrasound during walking

时间窗: single point assessment in one day during walking with the probe

Lengthening and shortening of the tendon of the medial gastrocnemius

Muscle belly dynamics measured with ultrasound during walking

时间窗: single point assessment in one day during walking with the probe

Lengthening and shortening of the muscle belly of the medial gastrocnemius

Fascicle dynamics measured with ultrasound during walking

时间窗: single point assessment in one day during walking with the probe

Lengthening and shortening of the fascicles of the medial gastrocnemius

次要结局

  • step width(single point assessment in one day during walking without the probe)
  • Step length(single point assessment in one day during walking without the probe)
  • lower limb kinematics(single point assessment in one day during walking without the probe)
  • gait speed(single point assessment in one day during walking without the probe)
  • stance phase(single point assessment in one day during walking without the probe)
  • swing phase(single point assessment in one day during walking without the probe)
  • gait speed(single point assessment in one day during walking with the probe)
  • step width(single point assessment in one day during walking with the probe)
  • Step length(single point assessment in one day during walking with the probe)
  • stance phase(single point assessment in one day during walking with the probe)
  • swing phase(single point assessment in one day during walking with the probe)
  • lower limb kinematics(single point assessment in one day during walking with the probe)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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