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临床试验/NCT06885294
NCT06885294Enrolling By Invitation不适用

Impact of Physiotherapy Combined to Hypnosis on Superior Limb Functional Capacities of AVC Patients

University of Liege1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
84
试验地点
1
主要终点
Measurement of joint ranges of motion

研究概览

简要总结

Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients.

详细描述

The cerebrovascular accident (CVA) is a pathology generating many disabled people. Physiotherapy is one of the usual rehabilitation techniques for a patient with sequelae of ischemia or cerebral hemorrhage. Combined with another therapeutic approach, hypnosis, it could increase the patient's motor performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Adults aged 18 to 80 years old
  • •Having experienced a stroke more than 3 months ago
  • •Understanding and proficient in the French language
  • •Having a functional capacity deficit in at least one of the two upper limbs
  • •Being able to independently travel to the Yerne medical center for necessary study appointments.

排除标准

  • •Being under 18 or over 80 years old
  • •Having a history of upper limb injuries (fractures, prosthetics, etc.)
  • •Having Wernicke's aphasia (language comprehension disorder)
  • •Having frontal lobe syndrome
  • •Undergoing chemotherapy
  • •Having respiratory disorders (respiratory failure of more than 70%) or receiving oxygen therapy
  • •Having epilepsy
  • •Having dementia
  • •Having untreated hearing impairments
  • •Being diagnosed with schizophrenia or paranoïa
  • •Experiencing significant concentration difficulties

研究组 & 干预措施

Group 1 receiving physiotherapy only

Experimental

Stroke patients will receive physiotherapy of upper limbs

干预措施: Physiotherapy (Behavioral)

Group 2 receiving combined physiotherapy and hypnosis

Experimental

Stroke patients will receive physiotherapy of upper limbs under hypnosis

干预措施: Physiotherapy and Hypnosis (Behavioral)

Waitlist group 3 receiving delayed combined physiotherapy and hypnosis

Experimental

Stroke patients will receive physiotherapy of upper limbs under hypnosis one month after the other groups

干预措施: Control group Physiotherapy and Hypnosis (Behavioral)

结局指标

主要结局

Measurement of joint ranges of motion

时间窗: 8 weeks

Measurement of shoulder (flexion, extension, abduction, internal rotation, external rotation), elbow (flexion, extension), wrist (flexion, extension)

assessment of spasticity

时间窗: 8 weeks

Measurement of muscle activation on Ashworth scale (extension and flexion of shoulder, elbow, wrist, fingers, thumb) =\> 0%-100% (a higher score means a worse outcome)

functional tests for the upper limb

时间窗: 8 weeks

Stroke Upper Limb Capacity Scale (SULCS) =\> 0%-100% (a higher score means a better outcome) * using one forearm as support while sitting * wedging an object between the chest and the upper part of the affected limb * sliding an object across a table while sitting * partially unscrewing a lid * taking a glass of water and drinking it * grabbing a tennis ball presented at a certain height * coming one's hair with the affected upper limb * buttoning * writing

scales for assessing disability and functional independence

时间窗: 8 weeks

Functional Independence Measure (FIM) from complete dependence to independence =\> 0%-100% (a higher score means a better outcome) * personal care * sphincter control * mobility, transfers * locomotion * communication * awareness of the external world

evaluation of muscle strength

时间窗: 8 weeks

Measurement of pathological upper limb strength on MRC scale by group/time/joint/movement =\> 0%-100% (a higher score means a better outcome) * Shoulder Flexion Strength * Shoulder Extension Strength * Shoulder Abduction Strength * Shoulder Internal Rotation Strength * Shoulder External Rotation Strength * Elbow Flexion Strength * Elbow Extension Strength * Wrist Flexion Strength * Wrist Extension Strength * Finger Flexion Strength * Finger Extension Strength * Thumb Flexion Strength * Thumb Extension Strength

Box and Block Test (BBT)

时间窗: 8 weeks

Measurement of manual dexterity and motor skills by moving blocks into box comparing healthy upper limb with pathological upper limb =\> 0%-100% (a higher score means a better outcome)

Modified Rankin Scale (mRS)

时间窗: 8 weeks

Measurement of degree of disability =\> 0%-100% (a higher score means a worse outcome)

次要结局

未报告次要终点

研究者

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

Audrey Vanhaudenhuyse

Professor

University of Liege

研究点 (1)

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