NCT05884762招募中不适用
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
研究概览
简要总结
The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke.
Researchers will compare :
Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The occupational therapist who will include and do the sessions will be open. The assessors who will test motor functions during the assessments will be blind
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
- 否
入选标准
- •Unilateral ischaemic or haemorrhagic stroke
- •Adult (18-80 years), both sexes
- •Stroke < 3 weeks
- •Upper limb deficit defined by Shoulder Abduction Finger Extension score <5 measured during the 7 days following stroke; i.e., patients predicted to have incomplete recovery
- •No participation-limiting comprehension problems
- •With or without homonymous lateral hemianopia; with or without visuospatial hemineglect
- •Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature).
- •Affiliated to french social security
排除标准
- •Ischemic or hemorrhagic brain stem and/or cerebellum involvement
- •Multiple strokes
- •Stroke < 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke
- •Aphasia with major comprehension impairment
- •Contraindication to MRI
- •pacemaker or implantable defibrillator,
- •neurosurgical clips,
- •cochlear implants,
- •intra-orbital or encephalic metallic foreign bodies,
- •stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago,
- •claustrophobia. (Patients who have undergone thrombolysis or thrombectomy may be included in the study.)
研究组 & 干预措施
Interventional group
Experimental
electroencephalographic neurofeedback + traditional reference rehabilitation programme
干预措施: electroencephalographic neurofeedback (Other)
Control group
Sham Comparator
SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
干预措施: SHAM electroencephalographic neurofeedback (Other)
结局指标
主要结局
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
时间窗: 28 days
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
次要结局
- Progression in The Stroke Impact Scale (SIS)(3 months)
- Brain datas (fMRI activity and CST tractography)(28 days)
- Changes in Action Research Arm Test (ARAT) score(3 months)
- Progression in The Composite Functional Independence Scale (MIF)(3 months)
- Progression in Evaluation of the Motor activiy Log (MAL)(3 months)
- Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones(28 days)
- Changes in force emitted (in kg) during a palmar grip (JAMAR)(3 months)
- Changes in ACTIVE RANGE OF MOTION (CxA) composite score(3 months)
- Changes in Action Research Arm Test (ARAT) score(28 days)
- Changes in force emitted (in kg) during a palmar grip (JAMAR)(28 days)
- Changes in ACTIVE RANGE OF MOTION (CxA) composite score(28 days)
- Progression in Evaluation of the Motor activiy Log (MAL)(28 days)
- Progression in The Composite Functional Independence Scale (MIF)(28 days)
- Progression in The Stroke Impact Scale (SIS)(28 days)
- Acceptability of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)(3 months)
- Acceptability of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)(3 months)
- Acceptance of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)(3 months)
- Acceptance of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)(3 months)
研究者
研究点 (1)
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