Stroke Clinical Trial
Official title:
The Effect of Vibration Therapy and Mirror Therapy on Upper Limb Function in Patients With Stroke
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.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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, 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. Exclusion criteria: 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). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Imam Abdulrahman Bin Faisal University |
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Assessment (FMA) | 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). | 30 mins to 35 mins | |
Secondary | Jebsen-Taylor Hand Function Test | It is an objective standardized assessment that emphasizes on activities of daily living (ADLs), employs time as a parameter and is not specifically related to any given health condition. It is applied for manual dexterity needed ADL, which was developed by Jebsen et al. in 1969. The assessment can be quickly administered, as it requires only handy available materials. Patients need 15 minutes to complete and therapists need equal time to administer. It involves 7 subsets: "writing, turning over 3 x 5-inch cards (to simulate page turning), picking up common small objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects". The timer is used to calculate the time consumed to execute tasks (Fabbri et al., 2021). It is developed to give information about a person's hand function, including strength, coordination, and dexterity. It is reliable (Hilário, Caiano, Ricci & Fonseca. 2022), and valid (Tofani, et al., 2020). | 15 mins | |
Secondary | Arabic version of DASH | The Arabic DASH is a measure that was developed as self-rated upper-extremity disability and symptoms. It is like the original DASH, and has the following 30 items: 21 questions pertaining to the degree of difficulty the patient experiences when performing various functional tasks involving the arm, the shoulder, and/or the hand; 5 questions addressing the severity of each symptom of pain, activity-related pain, tingling, stiffness and weakness; and 4 questions describing issues that affect social activities, work and sleep, as well as the psychological impact. It was optional to respond to question number 21, which deals with sexual activities because it is sensitive in the Arabic culture (Appendix 3). The Arabic DASH was presented with Cronbach's alpha of 0.94, and the Test-retest reliability was excellent with an ICC of 0.97 (Alotaibi, Aljadi & Alrowayeh, 2016). | 5 minutes |
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