The Effect of Vibration Therapy and Mirror Therapy on Upper Limb Function in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
Due to lack of evidence about the difference between the effects of Vibration Therapy and Mirror Therapy on stroke patients, this study aims at comparing the two, in the context of hemiparesis, to help patients improve hand motor functioning and gain occupational recovery. This study applies a two-arm parallel group randomized trial with 36 participants aged 30-65, who had sub-acute stroke 6 months before the study recruitment, and upper limb function deficits of Brunnstrom stage ≥ 3, the spasticity of affected upper extremity score ≤ 2 on the modified Ashworth scale. The participants are outpatients from Jazan Region, Saudi Arabia, and the intervention lasts 4 weeks, with sessions of 35-45 minutes, 3 days per week including the standard conventional therapy. The outcome measurements include Fugl-Meyer Assessment for motor assessment, A Jebsen-Taylor Hand Function Test (JTHFT) objective standardized assessment for activities of daily living (ADLs) and a 30-item Arabic and validated version of Disability of Arm, Shoulder and Hand (DASH) for the upper extremities.
详细描述
Inclusion criteria:
The participants will be selected from outpatient settings, and should meet the inclusion criteria, i.e. the participants who have suffered sub-acute stroke, have experienced first stroke within 6 months prior to the study recruitment, the spasticity of affected upper extremity score ≤ 2 on the modified Ashworth scale, as defined in a previous relevant study (Ahn, Kim & Park, 2019). Additionally, the age group will range between 30 and 65 years, as defined in a relevant previous study (Hardiyanti et al., 2014). The study should also include participants who are able to extend at least 10° at the fingers and at least 20° at the wrist, as well as intact sensation (Protective Reaction). Participants should be included if Visual Analog Scale (VAS) for pain assessment shows the score 4 or less, out of 10 (Ahn, Kim & Park, 2019). Furthermore, participants should have an acceptable level of cognitive function (MMSE scores 25 or more) (Ahn, Kim & Park, 2019), as well as acceptable and understandable level of verbal communication.
Exclusion criteria:
Participants will be excluded if they are active participants in another rehabilitation program or other experimental studies, or if there is evidence of having any traumatic or congenital upper limb injuries prior to the stroke. Additionally, participants who are evidenced of having a significant medical problem, such as cardiorespiratory, dysphasia, Wernicke's aphasia, and the use of muscle relaxants or suffering contraindications will be excluded. Moreover, patients who have contraindication of Vibration Therapy, such as acute thrombosis, pregnancy, implants in trained body parts, severe diabetes, activated arthrosis or arthropathy, acute hernia, acute discopathy, fresh fractures in trained body parts, kidney stones, a surgery of trained parts and epilepsy will be excluded (Albasini & Krause, 2010). Further contraindications will make participants excluded if they have serious cardiovascular disease, pacemaker, spondylolysis, severe diabetes, recent infections, severe migraine, tumors, interauterine devices, metal pins or plates, kidney stones, recent infections, organ failure and any contraindication to the use of WBV (Albasini & Krause, 2010). Furthermore, participants will be excluded if the mirror image of two intact limbs evoked persistent emotional reactions, dizziness, sweating and nausea (Rothgangel & Braun, 2013).
Sampling technique as the following:
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 (Outcomes Assessor)
盲法说明
The study will apply randomization sequence available on an online site https://www.randomizer.org/procedure, which will be performed by an independent person who is not included in the study. Allocation concealment was completed by the method of sequentially numbering opaque sealed envelopes (SNOSE), which depicted block randomization to ensure the allocation of equal number of participants in each group (Doig & Simpson, 2005). Based on the inclusion and exclusion criteria, participants will be randomly distributed in either group A or group B.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants will be selected from outpatient settings, and should meet the inclusion criteria, i.e. the participants who have suffered sub-acute stroke, have experienced first stroke within 6 months prior to the study recruitment, have upper limb function deficits of Brunnstrom stage ≥ 3, the spasticity of affected upper extremity score ≤ 2 on the modified Ashworth scale, as defined in a previous relevant study (Ahn, Kim & Park, 2019). Additionally, the age group will range between 30 and 65 years, as defined in a relevant previous study (Hardiyanti et al., 2014). The study should also include participants who are able to extend at least 10° at the fingers and at least 20° at the wrist, as well as intact sensation (Protective Reaction). Participants should be included if Visual Analog Scale (VAS) for pain assessment shows the score 4 or less, out of 10 (Ahn, Kim & Park, 2019). Furthermore, participants should have an acceptable level of cognitive function (MMSE scores 25 or more) (Ahn, Kim & Park, 2019), as well as acceptable and understandable level of verbal communication.
排除标准
- •Participants will be excluded if they are active participants in another rehabilitation program or other experimental studies. Subjects will be also excluded if there is evidence of having any traumatic or congenital upper limb injuries prior to the stroke. Additionally, participants could be excluded if they are evidenced of having a significant medical problem, such as cardiorespiratory, dysphasia, Wernicke's aphasia, and the use of muscle relaxants or suffering contraindications. Moreover, participants will be excluded if they have contraindication of Vibration Therapy, such as acute thrombosis, pregnancy, implants in trained body parts, severe diabetes, activated arthrosis or arthropathy, acute hernia, acute discopathy, fresh fractures in trained body parts, kidney stones, a surgery of trained parts and epilepsy (Albasini & Krause, 2010). Further contraindications will make participants excluded if they have serious cardiovascular disease, pacemaker, spondylolysis, severe diabetes, recent infections, severe migraine, tumors, interauterine devices, metal pins or plates, kidney stones, recent infections, organ failure and any contraindication to the use of WBV (Albasini & Krause, 2010). Furthermore, participants will be excluded if the mirror image of two intact limbs evoked persistent emotional reactions, dizziness, sweating and nausea (Rothgangel & Braun, 2013).
研究组 & 干预措施
Vibration Therapy
Vibration Therapy uses vibration as a physical tool during the treatment. It can be applied with different devices that transmit mechanical vibration throughout the whole or a part of the body. Focal Muscle Vibration (FMV) is a safe, well-tolerated and non-invasive technique, which may be an efficient intervention in reducing the upper extremity spasticity, whereas Whole Body Vibration (WBV) can provide proper somatosensory stimulation, and improve muscle strength and postural control in stroke patients (Oliveira et al., 2018).
干预措施: Vibration Therapy (Galileo Dela Interface) (Device)
Mirror Therapy
Mirror Therapy is a structured, inexpensive, simple and patient-directed treatment. The principle of Mirror Therapy is the use of a mirror to create a reflective illusion of an affected limb, in order to trick the brain into thinking the movement has occurred without pain. It has shown to improve movements of the affected upper limb and the ability to carry out daily activities, in addition to reducing pain (Dhami et al., 2019).
干预措施: Mirror Therapy ( Mirror Box) (Device)
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: 30 mins to 35 mins
Fugl-Meyer Assessment (FMA) was developed by Axel Fugl-Meyer in 1975 and known as Fugl-Meyer Assessment for the upper limb (FMA-UE). FMA is a stroke-specific standardized assessment instrument for assessing motor functioning, sensation and joint function in post stroke patients. This assessment was developed in English, and it is valid and reliable with an excellent total motor score (ICC=0.98) (Kim et al, 2012).Moreover, the FMA motor assessment for the upper (maximum score 66 points) and lower (maximum score 34 points) extremities are the key measurements in every stroke recovery and rehabilitation experiment. The score of 0 is given when the task cannot be completed, the score of 1 is given when the task is partially completed, and the score of 2 is given when the task is fully completed (Fugl-Meyer et al., 1975) (Appendix 2).
次要结局
- Jebsen-Taylor Hand Function Test(15 mins)
- Arabic version of DASH(5 minutes)
研究者
Hassan Saror
PhD Candidate in Neurological Rehabilitation Sciences
Imam Abdulrahman Bin Faisal University