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临床试验/NCT06740279
NCT06740279尚未招募不适用

Investigating the Upper Limb During the First 6 Months After Sustaining a Cervical Spinal Cord Injury,

Vastra Gotaland Region0 个研究点目标入组 210 人开始时间: 2025年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
210
主要终点
Motor neuron testing

研究概览

简要总结

The goal of this observational study is to investigate and describe the injury patterns, secondary complications, and biomechanical properties of the upper limb during the initial 6 months post-SCI.

The overarching objective is to investigate and describe the trajectory of upper limb functioning, secondary complications, and biomechanical properties of the upper limb during the initial 6 months post-SCI and explore factors influencing functional use of the hands at 6 months after injury.

详细描述

INTRODUCTION Sustaining a cervical spinal cord injury (SCI) leads to tetraplegia with paralysis in all four extremities. It is a traumatic event that radically changes an individual's ability to perform activities of daily life. Our arms and hands are critical functions since most of our daily activities depend on our hands. A person with tetraplegia also needs the upper limb (UL) to compensate for the paralysed legs in activities such as wheelchair mobility and transfers. Recovery of hand function has in several studies been depicted as the most important function to recover by people with tetraplegia.

Despite the importance of hand function, the evidence for treatment and optimization of the UL after tetraplegia is underdeveloped. Intervention studies targeting the tetraplegic UL typically focus on a single intervention and individuals in a chronic stable phase. The international clinical experience is that there are known factors that has the potential to impact the UL after c-SCI and studies investigating the incidence, timeframes and potential consequences for a functional UL in the acute and early phase are lacking.

Aim/Study rationale The overarching objective is to develop and assess a structured treatment plan for upper limb rehabilitation following cervical spinal cord injury (SCI). The ultimate aim is to empower patients with functional hands that enable daily living activities, emphasizing optimized grip strength and minimal range of motion limitations.

To achieve this, it is crucial to thoroughly investigate and describe the injury patterns, secondary complications, and biomechanical properties of the upper limb during the initial 6 months post-SCI.

METHODS Data collection and study sites This is a prospective cohort study. The study is designed to cover the absolute majority of people sustaining a cervical SCI during one year in Sweden and New Zealand. Inclusion criteria is to be found in the study design section. Following study sites will be included; in Sweden; Region Skåne, Region Västerbotten, Region Stockholm, Västra Götalandsregionen. In New Zealand, the two national spinal units in Auckland and Christchurch. Additional data will be collected from Lyndhurst Toronto rehab, KITE, Toronto, Canada. The Swiss Paraplegic Center, Notwill Switzerland will also be involved. Data will be collected at 1,2,3 and 6 months after sustained c-SCI. When available, additional assessment 1-2 weeks after injury will be included. The study aims to recruit patients for one year.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Signed informed consent
  • Acute onset Cervical SCI (traumatic and non-traumatic) C0-C7 AIS A-D that affects motor function in the upper limb.
  • Over the age of 18 at admission
  • Admitted for rehabilitation at one of the study sites.

排除标准

  • For the surveys: Inability to understand Swedish or English in writing.

结局指标

主要结局

Motor neuron testing

时间窗: 1,2,3,6 months post injury

Motor neuron testing, using the well established NeuroMuscular Electrical Stimulation (NMES). Identification of the LMN integrity in defined muscle will be done by surface electrical stimulation of the forearm according to standardized technique (Bersch 2018). A standard four-channel nerve stimulator ( Chattanooga Rehab SKU 2533110-INT) will be used and with stimulation parameters according to international recommendations for nerve/muscle stimulation; 20-80 mA, 250-300 μs at 35 Hz (Bersch 2022). All stimulators have CE approval, approved as medical technical product (medicinteknisk produkt) in Sweden and manuals in both Swedish and English are available. The stimulator will be used within approved area.

次要结局

未报告次要终点

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

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