Effects of Transcranial Direct Current Stimulation Combined With Constraint-Induced Therapy on Upper Limb Motor Function in Individuals After Stroke: A Randomized Controlled Trial
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
- 2
- 主要终点
- Change in upper limb motor function
研究概览
简要总结
The objective of this clinical trial is to evaluate the effects of transcranial direct current stimulation (tDCS) combined with constraint-induced therapy (CIT) on upper limb motor recovery in individuals after stroke.
The main questions it aims to answer are:
Does the combination of tDCS and CIT improve upper limb motor function compared to CIT alone?
Does the combined intervention promote changes in muscle morphology and electromyographic activity?
Researchers will compare the group receiving tDCS combined with constraint-induced therapy to the group receiving constraint-induced therapy alone to determine whether the addition of cortical neuromodulation enhances motor recovery outcomes.
This is a randomized, controlled, and blinded clinical trial in which participants will be divided into two groups: one group will receive tDCS combined with CIMT, and the other will undergo only CIMT. The protocol will include 18 sessions over six weeks, three times a week.
Clinical and instrumental assessments will be performed before, during, and after the intervention, including the Fugl-Meyer scale for the upper limb, musculoskeletal ultrasound for morphological analysis, and surface electromyography for muscle activity assessment.
详细描述
The target population will include individuals aged between 40 and 80 years, of both sexes, diagnosed with stroke as defined by the International Classification of Diseases (ICD-10) with mild to moderate impairment in the upper limb according to the Fugl-Meyer Assessment - Upper Extremity (FMA-UE) scale, who present alterations in the muscle function of the affected upper limb.
A convenience sample will be used, with an estimated inclusion of 40 (forty) individuals who meet the inclusion and exclusion criteria.
STAGE 1: Patients will be recruited through UEAFTO and contacted by the responsible researcher. Initially, the objectives and procedures of the research will be briefly explained and, after the participant's agreement, the evaluation will be scheduled.
STAGE 2: Subsequently, the evaluation form constructed by the student will be applied to rule out exclusion criteria and the FMA-UE and MMSE scales will be applied. After this stage, volunteers who are eligible and in accordance with the study's inclusion criteria and who are interested in participating will sign the Informed Consent Form (APPENDIX C), referring to voluntary participation, where the researchers will explain and deliver in duplicate the document reporting how the research will take place and its objectives. It is worth noting that the Informed Consent Form will be signed on all pages by the volunteers.
The measurement of all assessment instruments will be carried out at three times: (1) in the pre-treatment period, on the first day, before the start of the interventions; (2) during the treatment, in the 9th session; and (3) in the post-treatment period, 15 days after the end of the 18 sessions, corresponding to the follow-up period.
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 (Participant)
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
- 否
入选标准
- •present a clinical diagnosis of stroke confirmed by imaging examination and/or report issued by a neurologist; - are in the chronic phase of the lesion with an occurrence time greater than six months; - hemiparesis with brachial predominance, mild to moderate motor deficit in the affected upper limb defined by a score between 19 and 55 points on the FMA-UE; - have minimum joint integrity to perform the movements required in the protocol with an active range of motion of at least 20° of wrist extension, 10° of extension of the metacarpophalangeal and interphalangeal joints and 20° of elbow extension considering the standard position of 90° elbow flexion, measured with a Carci® goniometer; - demonstrate the ability to understand and follow simple commands on the Mini Mental State Examination (MMSE) (ANNEX II) with a score higher than 23 points for literate persons and lower than 15 points for illiterate persons.
排除标准
- •diagnosis of epilepsy; - intracranial metallic implants or implantable electronic devices; - contraindications to transcranial direct current stimulation (tDCS), including skin lesions on the scalp; - severe musculoskeletal limitations that prevent the execution of tasks; - history of recurrent stroke; - associated disabling musculoskeletal and neurological pathologies; (7) use of botulinum toxin in the previous three months; - uncontrolled systemic arterial hypertension or diabetes mellitus; - clinically relevant heart disease; - apraxia and aphasia of comprehension; - fracture and pain during movement or displacement of the affected limb, or pain related to shoulder subluxation. Those who feel uncomfortable, drop out of the research, do not respect the rules established in the Informed Consent Form (APPENDIX C), or do not attend the stages of the study will also be excluded.
研究组 & 干预措施
Transcranial direct current stimulation + Constraint-induced movement therapy
干预措施: transcranial direct current stimulation (tDCS) (Device)
Transcranial direct current stimulation + Constraint-induced movement therapy
干预措施: Constraint-induced movement therapy (Behavioral)
Constraint-induced movement therapy
干预措施: Constraint-induced movement therapy (Behavioral)
结局指标
主要结局
Change in upper limb motor function
时间窗: Baseline and 15 days after completion of the 18-session intervention protocol.
Change in motor function measured by the Fugl-Meyer Assessment - Upper Extremity (FMA-UE). The FMA-UE assesses motor impairment of the upper extremity, with total scores ranging from 0 to 66 points. Higher scores indicate better upper extremity motor function, whereas lower scores indicate greater motor impairment.
次要结局
- Secondary Outcome Measure: Muscle architecture assessed by musculoskeletal ultrasound(Initial assessment and 15 days after completion of the 18-session intervention protocol.)
研究者
Estefani Rani de Almeida Rodrigues
MSc Student - Principal Investigator
Universidade do Estado do Pará