Clinical trial NCT06126978: The Effect of Vibration Therapy and Mirror Therapy on Upper Limb Function in Patients With Stroke
Official title: The Effect of Vibration Therapy and Mirror Therapy on Upper Limb Function in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: stroke
CVA
Vibration therapy
Mirror Therapy
Conventional Therapy
Occupational Therapy
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

This study will apply convenience sampling where participants will be recruited according to their accessibility and availability.

Sample Size Calculation The sample size was calculated using statistical software (G\*Power 3.1.9.7) for Fugl-Meyer scale (FMS) obtained from a prior study (Dohle et al. (2008). The following combination was used to calculate the sample size: analysis of covariance (ANCOVA), fixed effect, main effects and interactions, ES of 0.6, and an alpha level of 0.05, power (1-β) of 80%, numerator df = 2, with two groups and two measurements (time points) and the number of covariates = 1. The expected sample size is 30 patients. Taking into consideration the attrition rate of 20%, 36 participants will be divided into two groups of 18 in each group.

Study Protocol (Therapeutic Interventions) The interventions of Vibration Therapy and Mirror Therapy will be provided by the primary investigator. The therapy sessions will be given 3 days per week. The length of therapy session in Group A (35 minutes of conventional therapy plus 30 minutes of Vibration Therapy). Yet, the length of session in Group B (35 minutes of conventional therapy plus 30 minutes of Mirror Therapy).

* Vibration Therapy: The device name that will be used is Galileo Dela Interface, Serial Number, 0001294, manufactured by Novotec Medical Gmbh Durlacher Str. 35. D-75172 Pforzheim, Germany. The Vibration Therapy should be provided in short sessions; each session is a 3-minute length and one minute break after each session (maximum 30 minutes). The maximum length of Vibration therapy session is 30 minutes, in addition to the 35 minutes of conventional therapy. The Vibration Therapy is described in each relevant appendix and it includes the following:-

  * Long press-up (Variation: 97 short press-up)
  * Objectives: Body stabilization, strengthening the shoulder and hips (Appendix 4)
  * Dips Page
  * Objectives: Body stabilization, strengthening the shoulders and the hips, (Appendix 4)
  * Short side - arm press-up
  * Objectives : Strengthening the whole body (Appendix 4)
  * Forearm Press-up Page
  * Objectives: Mobilization of the shoulder and neck (Appendix 5)
* Mirror Therapy: The device name that will be used is a SMART-MirrorTM (Sensory Motor Activity Retrainer), USA, with the visible shatter-proof, mirror area measures of 8 \* 13.4 (20\*34 cm). The Mirror Therapy will last for the treatment duration of 4 weeks with 30 minutes per day, 3 times a week, in addition to the conventional therapy. The following steps will be followed when performing Mirror Therapy:
* Ask the participant to place the tabletop mirror over the affected arm and hand, with the less-affected arm resting on the table next to the mirror, making sure that it is fully in view of the reflection; ensure the affected hand is out of view.
* Ask the participant to spend a few minutes observing the reflection and getting accustomed to the optical illusion.
* It can be helpful to think of the mirror as a window, instead of a reflection. This can help further "trick" the brain into thinking that participant is viewing his/her affected side.
* Then ask the patient to begin practicing simple hand therapy exercises with his/her non-affected hand. This can include touching his/her thumb with the fingertips, making a fist and then opening the hand, or turning his/her palm up and down.
* Then ask the participants to complete these Mirror Therapy stroke exercises for at least 10 minutes, working his/her way up to half-hour sessions. Make sure that participants keep their eyes on the reflection in the mirror the entire time.
* It is important to be strategic and repetitive with Mirror Therapy exercises. Practicing specific hand exercises repetitively will help activate neuroplasticity. The more the participants practice Mirror Therapy exercises, the more their brain will rewire itself, and the higher the chances of restoring hand and/or arm function.

Conventional therapy

The conventional Occupational Therapy for upper limb sub-acute stroke includes variety of rehabilitation interventions provided in the Jazan Rehabilitation centers. The therapy session lasts from 35 to 45 minutes, with a patient-specific treatment plan according to the patient's examination.

Outcome measures:

Primary Outcome measure:

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).

Secondary Outcome measures:

• Jebsen-Taylor Hand Function Test (JTHFT) is a standardized assessment that emphasis on activities of daily living (ADLs), employs time as a parameter and is not specifically related to any given health condition. It is an objective and standardized assessment 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 about 15 minutes to complete the assessment and therapists need equal time to administer it with their patients.

The assessment 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". All included subset tasks must be firstly fulfilled with the non-dominant hand and then followed by the dominant hand. The timer is used to calculate the time consumed to execute tasks (Fabbri et al., 2021). This test is developed to give information about a person's hand function, including strength, coordination, and dexterity. It is valid and there was a statistically significant positive linear Pearson's correlation coefficient between the MACS and JTHFT (p \< .01) (Tofani, et al., 2020). It is also reliable, its test-retest reliability varies from 0.53, 95% CI: 0.39-0.64; to 0.93, 95% CI: 0.91-0.95 for the dominant hand, and the non-dominant hand 0.66, 95%: 0.57-0.74; to 0.92, 95% CI: 0.90-0.94 (Hilário, Caiano, Ricci \& Fonseca. 2022).

• Another outcome measure, considered as the secondary outcome measure, is the Arabic version of DASH (Alotaibi, Aljadi \& Alrowayeh, 2016). The Arabic version of 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 version of DASH was presented with Cronbach's alpha of 0.94, and the Test-retest reliability was excellent with an ICC of 0.97. Construct validity of the DASH-Arabic with the SF-36 subscales and VAS scores ranged from r -0.32 to -0.57, all statistically significant P \> 0.001 (Alotaibi, Aljadi \& Alrowayeh, 2016).

These outcome measures will be assessed by an independent assessor, to determine the baseline pre-intervention, and at the end of therapy sessions after 4 weeks.

Eligibility criteria: 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).

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 30 mins to 35 mins
Secondary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: 15 mins
measure: Arabic version of DASH
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: IAU
name: Hassan Saror, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: IAU
name: Ali Alshami, PhD
role: STUDY_DIRECTOR
affiliation: IAU
name: Matar Alzahrani, PhD
role: STUDY_CHAIR
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