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临床试验/NCT06251661
NCT06251661
已完成
不适用

Cognitive Multi-sensory Rehabilitation on Upper Limb Functions and Fatigue in Different Grades of Spasticity in Stroke Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人2023年2月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Stroke
发起方
Cairo University
入组人数
40
试验地点
1
主要终点
Serum levels of Brain-Derived Neurotrophic Factor (BDNF)
状态
已完成
最后更新
3个月前

概览

简要总结

This interventional study aims to investigate the therapeutic efficacy of Cognitive multi-sensory rehabilitation (CMR) on upper limb function and fatigue in chronic stroke patients. The main question is:

• Does cognitive multi-sensory rehabilitation significantly affect upper limb function and fatigue in stroke patients? Participants will be assigned into two groups. They will receive 12 sessions of study group CMR and traditional physical therapy and control group traditional physical Therapy rehabilitation. CMR 40 minutes immediately followed by 20 minutes of selected physical therapy program, three sessions per week for four weeks.

详细描述

About 70% of people with stroke are unable to use their affected hand efficiently in activities of daily living. Further, post-stroke fatigue affects up to 92% of post-stroke patients. Post-stroke fatigue is a multifaceted motor and cognitive process, in which the patient experiences tiredness and lack of energy that develops during physical or mental activity which may persist for years. Post-stroke fatigue impacts the mental/physical functions of the patient through decreased energy, and thus, is a significant barrier to recovery. Preliminary evidence indicates sensory rehabilitation may enhance motor recovery in people with stroke. Cognitive Multisensory Rehabilitation (CMR) is a therapist-guided sensorimotor rehabilitation approach, that targets the patients' ability to solve sensory discrimination exercises, where the patient compares the sensations felt by the hand to the shapes observed with the eyes. Cognitive processes are encouraged by asking the patient to determine the limb movement or its position, how the movement was felt in the body, how the limb moved in relation to other parts of the body, and to spatial parameters in the environment. Because CMR integrates cognitive processes with sensory and motor tasks, it may be a novel method to address post-stroke fatigue, and it may increase connectivity in sensory and motor areas of the brain.

注册库
clinicaltrials.gov
开始日期
2023年2月1日
结束日期
2024年2月28日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Principal Investigator
主要研究者

Gehad Mohamed Mohamdeen Ali Mohamed

Lecturer Assistant

Cairo University

入排标准

入选标准

  • Age between 45 and 65 years.
  • 6-18 months after ischemic stroke
  • living in the community (i.e., not in a long-term care home).
  • medically stable.
  • normal score in the Montreal Cognitive Assessment (MoCA: 25 to 30, maximum score = 30).
  • Spasticity of upper limb muscles ranged from (grade 1:2) according to the Modified Ashworth scale.

排除标准

  • severe spasticity (Modified Ashworth Scale score of 4)
  • any medical condition that hinders full participation,
  • another neurological diagnosis beyond stroke including cognitive impairment, or
  • upper extremity pain \> 4/10 on the Numeric Pain Rating Scale (maximum 10/10).

结局指标

主要结局

Serum levels of Brain-Derived Neurotrophic Factor (BDNF)

时间窗: from baseline to four weeks after the beginning of intervention

Changes in serum levels of neural plasticity factors

Fugl-Meyer Assessment for upper extremity (FMT-UE).

时间窗: from baseline to four weeks after the beginning of intervention

Changes in upper limb function.

Changes in hand grip strength

时间窗: from baseline to four weeks after the beginning of intervention

Hand grip strength was measured by an electronic hand dynamometer device.

Fatigue Assessment Scale (FAS)

时间窗: from baseline to four weeks after the beginning of intervention

determine the degree of self-reported fatigue in daily living activities. Each item of the FAS is answered using a fi ve-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.

次要结局

  • Box and Blocks Test (BBT)(from baseline to four weeks after beginning of the intervention.)

研究点 (1)

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