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临床试验/NCT07798388
NCT07798388尚未招募不适用

Optimizing Gait Rehabilitation After Stroke: Neuromechanical Understanding and the Role of VR Feedback to Improve Arm Swing Functionality

University Hospital, Ghent3 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2026年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
93
试验地点
3
主要终点
Number of muscle synergies

研究概览

简要总结

Following a cerebrovascular accident (CVA, also known as a stroke), hemiparesis occurs on the side opposite to the brain injury. This can lead to problems with walking and balance, as well as with arm movements whilst walking. The arm swing serves several important functions whilst walking, such as improving your balance and energy efficiency, and a good arm swing helps to reduce the likelihood of falling if you lose your balance. That is why regaining the ability to walk independently with the best possible arm swing is a key goal during rehabilitation for people who have had a stroke. This ensures that the risk of falling is minimised and that people can resume their daily lives as effectively as possible.

The aim of this study is to gain a better understanding of the abnormalities in arm swing whilst walking in people who have had a stroke, and how we can influence them. To identify these abnormalities, we use surface electromyography, a painless technique that allows us to measure muscle activity whilst walking. To do this, we attach sensors to the muscles whose activity we wish to record.

During this study, we are measuring both people who have had a stroke and healthy adults, in order to detect the effects of a stroke on this muscle activity. The data from the healthy adults will be used to investigate whether we observe different muscle activity in people who have had a stroke.

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
None

入排标准

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

入选标准

  • First-ever ischemic or haemorrhagic stroke
  • Able to walk independently (FAC ≥ 3)
  • Able to walk at least ten minutes
  • No full recovery of the paretic upper limb (FMA-UL < 66)
  • Able to follow simple instructions during the assessment

排除标准

  • Lesions located in the cerebellum
  • Pre-existing neurological disorders that affect motor function (e.g., Parkinson's disease, multiple sclerosis, dementia, etc.)
  • Pre-existing orthopaedic disorders of the upper and/or lower limbs (e.g., shoulder prosthesis, knee prosthesis, etc.)
  • Inability to provide written informed consent
  • Inability to understand instructions (AbilityQ: verbal < 3/4 and VAS < 3/3)
  • Exclusion Criteria Healthy:
  • Pre-existing neurological disorders that affect motor function (e.g., Parkinson's disease, multiple sclerosis, dementia, etc.)
  • Pre-existing orthopaedic disorders of the upper and/or lower limbs (e.g., shoulder prosthesis, knee prosthesis, etc.)
  • Injuries of the upper and/or lower limbs that occurred six months or less prior to the time of testing
  • Current pain or ROM limitations at the time of testing
  • Inability to provide written informed consent

研究组 & 干预措施

neuromechanical understanding and the role of VR feedback to improve arm swing functionality

Experimental

干预措施: VR-feedback application (Other)

结局指标

主要结局

Number of muscle synergies

时间窗: Baseline, during intervention and immediately after the intervention.

The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors compared to healthy controls. Following muscles will be examined: * tibialis anterior * gastrocnemius lateralis * soleus * vastus medialis * vastus lateralis * rectus femoris * biceps femoris * gluteus medius * erector spinae * latissimus dorsi * anterior deltoid * posterior deltoid * biceps brachii * triceps brachii

Weight of muscle synergies

时间窗: Baseline, during intervention and immediately after the intervention.

The number or distribution of muscle weightings within a synergy during walking in stroke survivors compared to healthy controls. The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles: * tibialis anterior * gastrocnemius lateralis * soleus * vastus medialis * vastus lateralis * rectus femoris * biceps femoris * gluteus medius * erector spinae * latissimus dorsi * anterior deltoid * posterior deltoid * biceps brachii * triceps brachii

Upper and lower limb kinematics

时间窗: Baseline, during intervention and immediately after the intervention.

Movements of the upper limb during walking measured by 3D kinematics.

Physical Activity Enjoyment Scale (PACES)

时间窗: Single point of assessment immediately after the intervention

The PACES is a questionnaire on patient enjoyment of physical activity. It consists of 18 items rated on a 7-point Likert scale, with total scores ranging from 18 to 126.

Simulation Task Load Index (SIM-TLX)

时间窗: Single point of assessment immediately after the intervention

The SIM-TLX is a questionnaire to assess the workload in simulation and virtual reality. It consists of 10 items rated on a 21-point Likert scale, with total scores ranging from 21 to 210.

List of potential adverse effects

时间窗: Single point of assessment immediately after the intervention

A predefined list of potential adverse effects of the VR-feedback application is used to document any experienced adverse effects experienced by participants including an open section for additional unlisted effects.

次要结局

  • Fugl-Meyer assessment - Upper and lower limbs(Single point of assessment immediately after the intervention)
  • Modified Tardieu Scale(Single point of assessment immediately after the intervention)
  • Goniometry(Single point of assessment immediately after the intervention)
  • 10-Meter Walk Test (10MWT)(Single point of assessment immediately after the intervention)
  • Kessler Foundation Neglect Assessment Process (KF-NAP)(Single point of assessment immediately after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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