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临床试验/NCT06059755
NCT06059755招募中不适用

Comparison of Mirror Therapy Versus Cross- Education Non Paretic Limb Training on Upper Limb Strength and Hand Dexterity in Stroke Survivors.

Riphah International University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
26
试验地点
2
主要终点
Action Research Arm Test (For Functional Limitation)

研究概览

简要总结

A stroke is a significant contributor to functional decline and long-term disability. The reduction of obesity and improvement in quality of life are directly correlated. Many post-stroke patients experience persistent upper extremity dysfunction. The study aims to compare cross-education non-paretic limb training versus mirror therapy on upper limb strength and dexterous movement of hand in stroke survivors This randomized clinical trial will be conducted at DHQ Hospital Sargodha over a duration of six months. The sample size will consist of 26 participants. Participants which meet the inclusion criteria will be selected through Non probability convenience sampling technique, which will further be randomized through computer engendered in blocks by using basic number generator.13 participants will be assigned to Cross education group and 13 participants will be assigned to Mirror Therapy group. Data will be using various assessment tools, including the Action Research Arm Test (ARAT) for functional limitation, Fugl-Meyer Assessment-upper extremity (FMA-UE), Stroke Impact Scale (SIS) for hand dexterity and function. Hand held dynamometer will be used for Grip Strength Test. Pre intervention assessment will be conducted for both groups. The effects of intervention will be measured at pretreatment ,3rd week and post intervention. Data analysis will be performed by using SPSS (Statistical Package for Social Sciences) 23 version.

详细描述

A stroke or CVA is characterized by the sudden onset of focal neurological dysfunction symptoms that persist for more than 24 hours (or cause death earlier) and are brought on by an acute vascular injury to a specific area of the brain. Overall, a stroke creates a blockage in the delivery of blood and oxygen to a particular region of the brain, which results in cell death, long-term or lifelong impairments, or even death. Issues with paralysis, motor control, pain-related sensory problems, language usage or comprehension, thinking, memory, and emotional challenges are just a few examples of disabilities.

Stroke can be ischemic or hemorrhagic. Over 100 diseases are associated with ischemic stroke, making it heterogeneous. It is the most common type of stroke and accounts for 87% of all strokes. Ischemic stroke is further divided into two groups; thrombotic stroke (the formation of clot or plaque in blood vessels within the brain) and embolic stroke (the formation of clot or plaque somewhere else in the body and travels to blood vessel of the brain through blood stream).

Atherosclerosis, arterial dissection, and artery-to-artery embolism are all examples of large vessel disease. The primary small vessel diseases causing lacunar strokes are lipohyalinosis and atherosclerosis. Intracerebral hemorrhage, which can occur deep (basal ganglia, brainstem), cerebellum, or lobar, accounts for about 15% of strokes. About 20% of intracerebral hemorrhages are brought on by macro vascular lesions (vascular malformations, aneurysms, cavernomas), venous sinus thrombosis, or other uncommon causes; these are particularly significant in young patients.

Literature review A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines. Search term for the initial literature review was post-stroke mirror therapy, post-stroke cross education, comparison of mirror therapy versus cross education non paretic limb training, upper limb strength and hand dexterity.

O. van der Groen et al. (2023) studied the Corticospinal and intracortical responses from both motor cortices following unilateral concentric versus eccentric contractions and compared responses to transcranial magnetic stimulation(TMS) in both motor cortices following single sessions of unilateral ECC and CON exercise of the elbow flexor and concluded that These findings suggest that responses after a single bout of exercise may not reflect longer term adaptations.

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 (Investigator)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Age range between 45-65 years.
  • Both male and female genders.
  • Clinically diagnosed of stroke referred by Neuro physician.
  • Patients in the subacute stage, duration of 3 to 6 months from onset.
  • Patients with anterior cerebral artery (ACA) and middle cerebral artery (MCA) involvement with the affected side being the dominant side.
  • Patients with Mini-Mental State Examination (MMSE) score more than
  • According to Modified Ashworth Scale, patients in range of 1 and 1+ (Flexor carpal radialis muscle,Flexor carpal ulnaris muscle, Flexor digitorum profundus muscle, Flexor digitorum superficialis muscle, Flexor pollicis longus muscle, Palmaris longus muscle) will be included .
  • Hemiparesis or hemiplegic due to Ischemic stroke

排除标准

  • Patients with Alzheimer disease, Parkinson's disease, Multiple sclerosis and Brain tumors .
  • Those with severe cognitive impairment , those who were unable to provide informed consent. Patients having acute pericarditis, lumbar puncture within 7 days, Major surgery or major trauma within 14 days.
  • Patient with recurrent stroke.
  • With unilateral neglect or apraxia

结局指标

主要结局

Action Research Arm Test (For Functional Limitation)

时间窗: Changes from baseline Action Research Arm Test at 3rd week and after 6 weeks

The instrument contains 19 items grouped into 4 subtests; grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.

Fugl-Meyer Assessment. (For Upper extremity function)

时间窗: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks

The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis. The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The scores most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).Higher the score more is the independence.

Hand-held dynamometer. (For Upper Limb strength assessment)

时间窗: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks

This instrument is scored using force produced in kilograms (0-90) or pounds (0-200). The subject is seated with back, pelvis and knees as close to 90 degrees as possible, shoulder is adducted and neutrally rotated, elbow flexed to 90 degrees, and forearm neutral and wrist held between 0-15 degrees of ulnar deviation. Maximum grip is the mean of 3 trails.

Stroke Impact Scale (For hand function)

时间窗: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks

The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. It contains 59 items and assesses 8 domains: Strength - 4 items, Hand function - 5 items, ADL/IADL - 10 items, Mobility - 9 items, Communication - 7 items, Emotion - 9 items, Memory and thinking - 7 items, Participation/Role function - 8 items. For each item individual is asked to rate the level of difficulty in past two weeks using the scale;1= extremely difficult, 2= very difficult, 3= somewhat difficult, 4= a little difficult, 5= not difficult at all. On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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