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临床试验/NCT01879787
NCT01879787已完成2 期

Impact of Transcranial Direct Current Stimulation (tDCS)on the Effects of Mental Practice and Modified Constraint-induced Movement Therapy (mCIMT)in the Rehabilitation of Chronic Stroke Patients

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
84
试验地点
2
主要终点
Change from Fugl-Meyer Assessment of Upper Extremity Motor Function

研究概览

简要总结

This study aims to evaluate systematically and controlled the effectiveness of mental practice techniques and modified constraint- induced movement therapy (mCIMT)in the treatment of post-stroke patients with motor deficit in the upper limb. As well as finding a protocol of transcranial direct current stimulation(tDCS)that will maximize the effects of the practice of mental image and mCIMT. To this end, the subjects included will be submitted to 12 therapy sessions with active or sham tDCS combined with at least one of the following techniques: conventional physiotherapy, mental practice technique or mCIMT

详细描述

Eighty-four patients chronic post-stroke will be recruited to participate in the study. After screening to check the eligibility criteria and giving informed consent, the patients will be randomized into seven distinct groups (12 per group). All the patients will be submitted to 12 therapeutic sessions that will occur with a frequency of three times a week.

Before, immediately after and 1 month after the beginning of the experimental sessions patients will be submitted to an evaluation at each moment will be applied: (i) Fugl- Meyer Scale, (ii) Motor Activity Log Scale, (iii ) Jebsen-Taylor hand functional test, (iv) Independence Functional Measure (v) Box-Block Test, (vi) Dynamometry and (vii) Berg Balance Scale.

In experimental sessions, the subjects always receive physiotherapy treatment with conventional techniques, the protocol will follow the guidelines outlined in Clinical Practice Guideline for physical therapy in stroke patients with the Royal Dutch Society for Physical Therapy (2004). Besides physical therapy, the patient may be subjected to transcranial direct current stimulation (tDCS) associated with the techniques of modified constraint-induced movement therapy (mCIMT) or mental practice (MP).

tDCS protocol During tDCS sessions, the patients will be seated in a comfortable chair with head and arm rests. Continuous direct current will be applied by clinical microcurrent stimulator (Soterix, USA) using a pair of saline-soaked surface sponge electrodes (surface 35 cm2). For anodal and sham stimulation (the polarity refers always to the motor cortical electrode), the anode electrode will be placed over primary motor cortex (M1; EEG 10/20 system) of the affected hemisphere and cathode above contralateral orbit. For cathodal tDCS, the cathode will be positioned over M1 of the non-affected hemisphere and the anode was placed above the contralateral orbit. For bi-hemispheric tDCS the anode electrode will be placed over M1 of the affected hemisphere and the cathode over the M1 of the healthy hemisphere. Transcranial direct current stimulation will be administered with a current strength of 1 mA for 13 (anodal/bi-hemispheric tDCS) or 9 min (cathodal tDCS). Sham tDCS will be performed by current flow for 30 s, a method shown to achieve a good level of blinding mCIMT protocol The modified CIMT consisted of (i) complete immobilization of the non-paretic upper limb and (ii) intensive training the paretic upper limb and will be administered by a trained therapist, who was not involved in the pre-post evaluations.

Continuously for six hours daily over a period of four weeks, including weekend, all patients will be remained with complete immobilization of the non paretic upper limb. For this, an arm sling with the shoulder in adduction and internal rotation, elbow flexed at 90º, wrist and fingers in neutral position, made specifically for each patient will be used. They will be advised to use the restriction during their daily activities and instructed to remove it every hour for 10 minutes to perform stretching, which has been previously taught by the researchers to avoid functional deterioration caused by disuse. All muscle groups of the upper extremity will be stretched. A guide with instructions of the stretching will be distributed to patients. The patients will be instructed to take the immobilization on every day at same hour the tDCS sessions. In addition, the patients will be allowed to take the arm sling off during activities in which safety would be compromised, such as toileting, dressing, and bathing.

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, Care Provider, Investigator)

入排标准

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

入选标准

  • chronic stroke (> 6 months)
  • score ≥ 20 at the Folstein Mini Mental State Examination
  • score ≤ 3 at the Ashworth Scale
  • score ≤ 4 at the Visual Analog Pain Scale

排除标准

  • multiple brain lesions
  • medication for treatment of spasticity
  • attention deficit
  • deficit in perceptual ability and motivation to follow the instructions for the mental training
  • pacemaker
  • metal implant in the region of the skull and face
  • history of convulsion

结局指标

主要结局

Change from Fugl-Meyer Assessment of Upper Extremity Motor Function

时间窗: At baseline, 1 month and 2 month

The Fugl-Meyer assessment was used to measure recovery of motor control. It is a 226-point scoring system that includes range of motion, pain, sensation, motor function of the upper and lower extremities, and balance.This instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.

次要结局

  • Change from Motor Activity Log(At baseline, 1 month and 2 month)

研究者

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

Kátia Monte-Silva

PhD in Neuroscience

Universidade Federal de Pernambuco

研究点 (2)

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