Comparison Of Robotic And Conventional Mirror Therapy On Hand Motoric Recovery And Functional Outcomes For Rehabilitation Of Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- FMA-UE Score
研究概览
简要总结
This clinical trial aims to compare the effectiveness of Robotic versus conventional mirror therapy among post-stroke patients. The main questions it aims to answer are:
- Effectiveness of both interventions in hand motoric recovery across time
- Effectiveness of both interventions in functional outcomes across time
- Clinical outcome difference between both interventions Participants will be allocated into either a robotic group as the main intervention or a mirror therapy group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
详细描述
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Research design This research is an experimental study with a randomized controlled trial research design.
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Study Setting The research will be carried out among post-stroke patients at two teaching hospitals and one physical rehabilitation centre in Makassar
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Procedure
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Robotic Procedure an exoskeletal robot (Syrebo) will help and stimulate the movement of the paralyzed extremity. One set of training covering Activity Daily Living (ADL) set will be conducted. A mirror will reflect the movement of the healthy extremities
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Conventional Method the difference from the robotic procedure was, the movement and stimulation will be provided by the physical therapist.
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Time frame the procedure will be conducted in parallel three times per week for a total of six weeks
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Outcomes
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motoric ability of upper extremity using Fugl-Meyer Assessment for Upper Extremities (FMA-UE)
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Dexterity, coordination and response of finger using the Nine Hole Peg Test (NHPT)
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Covariates and potential confounders
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type of stroke determined by radiology imaging
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phase of stroke (acute, sub-acute or chronic)
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cognitive ability measured using mini-mental state examination (MMSE)
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Spasticity measured by the Modified Ashworth Scale (MAS)
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Procedure The data collected is primary data obtained in accordance with the inclusion criteria.
Samples who are willing to become research subjects will undergo interviews, physical examinations, FMA-UE-Hand Motor Domain and NHPT examinations. The interview questionnaire in this study will contain a list of patient identities including name, age, marital status, address, educational history, employment history, history of stroke, cognitive examination (MMSE), and self-reported visual ability.
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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 - 85 years.
- •Non-haemorrhagic stroke/infarction with onset more than 3 months from the onset of the attack.
- •Patients with unilateral upper limb hemiparesis.
- •Modified Ashworth Scale (MAS) on fingers and hands <3
- •The patient has not undergone mirror therapy treatment before.
- •Patients who are able to understand informed consent to participate in research.
- •The patient had a Radiology imaging of the head at the time of stroke onset.
排除标准
- •Patients with severe spasticity or contractures of the upper extremities.
- •Patients with infarction/bleeding with extensive lesions covering 2 hemispheres.
- •The patient has severe cognitive impairment that will interfere with the research objectives (MMSE score >24).
- •Patients post Digital Subtraction Angiography (DSA) procedures in the last 2 months.
- •Patients with a history of seizures or epilepsy.
- •Patients with visual field deficits or severe visual impairment.
- •Patients who are unable to sit upright without assistance.
- •Other uncontrolled medical conditions (musculoskeletal, neuromuscular, cardiorespiratory) that may interfere with the ability to exercise.
- •Dropout criteria:
- •Patients were excluded from the study if:
- •Participant dies.
- •Participants take part in the exercise <3 times for 2 consecutive weeks.
- •The participant refuses to continue the training session.
- •Participants experience hemodynamic disorders during the training program phase.
- •Participants experience neurological disorders during the training program phase.
结局指标
主要结局
FMA-UE Score
时间窗: changes of FMA-UE score from pre-intervention to six weeks after intervention
a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement
NHPT value
时间窗: changes of NHPT values from pre-intervention to six weeks after intervention
an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively.
次要结局
未报告次要终点
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University