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临床试验/NCT03236376
NCT03236376已完成不适用

Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Action Research Arm Test

研究概览

简要总结

Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor impairments are present in 67% of the stroke patients, resulting in problems with independency and performance of activities of daily life. In addition, the pattern of recovery in the brain is still a matter of ongoing debate. Although the importance of somatosensory function on motor performance is well described, evidence for somatosensory or sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the effect of a sensorimotor therapy compared to pure motor therapy on motor function of the upper limb. A second objective is to investigate therapy-induced brain-behavior associations using resting state functional Magnetic Resonance Imaging of the brain.

详细描述

Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor impairments are present in 67% of the stroke patients, resulting in problems with independency and performance of activities of daily life. In addition, the pattern of recovery in the brain is still a matter of ongoing debate. Although the importance of somatosensory function on motor performance is well described, evidence for somatosensory or sensorimotor therapy and brain-related changes is scares. Therefore, will conduct a Randomized Controlled Trial with three main objectives.

The first objective of this project is to investigate the effect of sensorimotor therapy on motor function of the upper limb. To achieve this objective, a sensorimotor program will be developed based on the SENSE therapy. Patients will be randomly allocated to either the sensorimotor therapy group or the pure motor therapy group; and will receive 16 hours of therapy. Motor and Somatosensory assessments will be performed at three time points: baseline(admission to rehabilitation center), immediately after the 16 hours of therapy and after 4 weeks of follow-up.

The second objective is to investigate therapy-induced brain-behavior associations with resting state functional connectivity. In order to achieve insights in brain-behavior associations, we will perform resting-state functional Magnetic Resonance Imaging (fMRI) scans at the same time points as the clinical assessments: baseline, immediately after the 16 hours of therapy, and four weeks after the end of the therapy. Both measurements, brain-imaging and clinical measurements will be combined to investigate the associations.

This project will lead to new insights in brain-behavior associations of sensorimotor function of the upper limb after stroke and will provide evidence for a new therapy in upper limb stroke rehabilitation.

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
Single (Outcomes Assessor)

盲法说明

The assessor will be masked for treatment group

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 stroke as defined by the WHO (world health organisation) criteria
  • assessed and included within 8 weeks after stroke onset
  • unilateral motor impairment in the upper limb (ARAT <52/56)
  • unilateral somatosensory impairment in the upper limb (SSD <0.00)
  • minimally 18 years old
  • substantially cooperation to perform the assessments and therapy
  • written informed consent

排除标准

  • musculoskeletal and/or other neurological disorders such as previous stroke, head injuries, multiple sclerosis of Parkinson's disease
  • a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke
  • severe communication deficits
  • severe cognitive deficits
  • the presence of contra-indications for proceeding an MRI scan such as defibrillator, pacemaker or metal prosthesis ( as defined in the MRI checklist of Radiology UZ Leuven)

结局指标

主要结局

Action Research Arm Test

时间窗: within 4 months post stroke

grasp, grip, pinch and gross movement of the affected arm and hand

次要结局

  • Fugl-Meyer motor Assessment-upper Extremity(within 4 months post stroke)
  • composite standardized somatosensory deficit index(within 4 months post stroke)
  • Erasmus modified Nottingham Sensory Assessment(within 4 months post stroke)
  • Perceptual Threshold of Touch(within 4 months post stroke)
  • Nine Hole Peg test(within 4 months post stroke)
  • Stroke Upper Limb Capacity Scale(within 4 months post stroke)
  • functional connectivity(within 4 months post stroke)

研究者

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

Geert Verheyden

Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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