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临床试验/NCT05520489
NCT05520489Unknown不适用

Upper Limb Rehabilitation in First Year After Stroke Using Modern Treatment Strategies (rTMS, Robot Assisted Training and Intensive Motor Training ) - a Single Case Study

Satasairaala2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
Fugl-Meyer Assessment

研究概览

简要总结

Stroke is a major cause of disability in worldwide, causing billions of euros direct and indirect costs to the community. Upper limb motor dysfunction is seen in about 50% stroke survivors. Upper extremity paresis is identified as a strong component for performing activities of daily living (ADL) (Veerbeek 2011). Upper-limb rehabilitation is crucial during the first three to six months since the onset of stroke because the motor and ADL-performance recovery of stroke survivors declines afterward (Kwakkel & Kollen, 2013, Wade et al., 1983). The main advantages of using robot-assisted therapy are to deliver high-dosage and high-intensity training (Sivan et al., 2011). Robot-assisted training enables a greater number of repetitive tasks to be practised in a consistent and controllable manner. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke (Pollock 2014) and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke.

Repetitive transcranial magnetic stimulation (rTMS) is the field of interest and is incorporated to stroke rehabilitation in many institutes. Low-frequency rTMS to the unaffected hemisphere could normalize the inhibitory imbalance between hemispheres (Adeyemo et al., 2012). The safety and application guidelines of transcranial magnetic stimulation were extensively reviewed by Rossi et al. (2009). It is opposed that there is no effect of rTMS alone on upper extremity (UE) disabilities, but rTMS in combination with another rehabilitation treatment potentiates the effect of the rehabilitation treatment alone with regards to UE impairment. There is inconclusive evidence that the combined treatment (rTMS + conventional rehabilitation) have effect on UE disabilities. Treatment effects have been described in acute, subacute and chronic stroke patients, though it is proposed, that there is lack of late subacute phase rTMS studies that used FMA for outcome measure (van Lieshout, 2019).

In this single-case study the investigators compare different rehabilitation modules - self exercising (baseline), robot assisted training, rTMS and intensive motor training guided by therapist, to improve the use of paretic hand. The aim of this study is to show if there is clinically relevant improvement of the motion or function of upper extremity in different treatment strategies and if any of these treatment is superior to self-training.

详细描述

Introduction Stroke is a major cause of disability in worldwide, causing billions of euros direct and indirect costs to the community. Upper limb motor dysfunction is seen in about 50% stroke survivors. Upper extremity paresis is identified as a strong component for performing ADL (Veerbeek 2011, 1). Hemi-paretic upper extremity causes reduction of capacity to carry out different types of functional tasks like reaching, grasping and manipulation that may lead to difficulty in activities of daily life (Yavuser 2008, 2). Upper-limb rehabilitation is crucial during the first three to six months since the onset of stroke because the motor and ADL-performance recovery of stroke survivors declines afterward (Kwakkel & Kollen, 2013, Wade et al., 1983) (3-4).

Improvement probably occurs through a complex combination of spontaneous and learning-dependent processes including: restitution, substitution, and compensation (Kwakkel et al., 2004; Langhorne et al., 2011)(5-6). Until the third month after stroke onset, a variable spontaneous neurological recovery can be considered a confounder of rehabilitation intervention (Kwakkel et al., 2006)(7). Progresses in functional outcome appearing after 3 months seem largely dependent on learning adaptation strategies (Kwakkel et al., 2004)(5). Evidence suggests that neurological repair through brain reorganization supporting true recovery or, alternatively through compensation, may also take place in the subacute and chronic phase after stroke (Krakauer, 2006)(8).

Since upper limb paresis is shown to be major factor for performing ADL activities and is strongly related to independence in self-care, there is urgent need to find methods to improve the function of paretic upper limb.

Motor training, functional training and goal-setting are traditional rehabilitation methods that are widely used and are often the treatment standard for stroke patients.

In the recent Cochrane review it was concluded that robot assisted therapy can improve activities of daily living, arm function, and muscle strength of the paretic arm (Mehrholz, 2018)(9). The main advantages of using robot-assisted therapy are to deliver high-dosage and high-intensity training (Sivan et al., 2011)(10). Robot-assisted training enables a greater number of repetitive tasks to be practised in a consistent and controllable manner. Repetitive task training is known to drive Hebbian plasticity, where wiring of pathways that are coincidently active is strengthened (Hallett 1999, Hebb 1949)(11,12). A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke (Pollock 2014)(13) and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults with hemiparesis/hemiplegia due to stroke (ischaemic or haemorrhagic)
  • stroke diagnose within the previous 2-9 months (subacute phase)
  • upper extremity Fugl-Meyer (FMA) motor score < 56.

排除标准

  • patient is unable to understand instructions
  • transcranial magnetic stimulation contraindications (Rossi 2009, Rossini 2015)
  • concurrent medical condition likely to worsen functional status within 6 months

结局指标

主要结局

Fugl-Meyer Assessment

时间窗: 3 weeks

Upper extremity motor, sensory, pain and movement assessment with higher value showing better results.

active range of motion in shoulder joint, elbow, wrist

时间窗: 3 weeks

measured either by robotic device or goniometer; strength of hand and fingers (Jamar, Pablo) and shoulder proprioception (when the active movement of shoulder joint enabled assessment with laserpointer and target).

次要结局

  • Life Satisfaction(4 months)
  • Quality of life Eq-5D(4 months)
  • Quality of life Eq-5D Visual Analogue Scale(4 months)
  • World Health Organization Disability Assessment Schedule 2.0(4 months)
  • Hospital Anxiety and Depression Score(4 months)
  • International Classification of Function 15 Dimensions(4 months)

研究者

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

Aet Ristmägi

Medical Doctor

Satasairaala

研究点 (2)

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