The Effect of Vibration Therapy and Mirror Therapy on Upper Limb Function in Patients With Stroke

NCT06126978 | Unknown

• 1 other identifier: Vibration& Mirror Therapy
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Upper Extremity Paresis

Keywords

stroke; CVA; Vibration therapy; Mirror Therapy; Conventional Therapy; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Jebsen-Taylor Hand Function Test

  15 mins

• Arabic version of DASH

  5 minutes

Study Arms (2)

Vibration Therapy

EXPERIMENTAL

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).

Device: Vibration Therapy (Galileo Dela Interface)

Mirror Therapy

EXPERIMENTAL

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).

Device: Mirror Therapy ( Mirror Box)

Interventions

Vibration Therapy (Galileo Dela Interface) DEVICE

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).

Vibration Therapy

Mirror Therapy ( Mirror Box) DEVICE

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).

Mirror Therapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Related Publications (32)

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MeSH Terms

Conditions

Stroke; Paresis

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Hassan Saror, PhD(c)

  IAU

  PRINCIPAL INVESTIGATOR

• Ali Alshami, PhD

  IAU

  STUDY DIRECTOR

• Matar Alzahrani, PhD

  IAU

  STUDY CHAIR

Central Study Contacts

Hassan Saror, PhD(c)

CONTACT

0508764190; 2210700011@iau.edu.sa

Ali Alshami, PhD

CONTACT

0501912299; alshami@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate in Neurological Rehabilitation Sciences

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 27, 2023
• Primary Completion: April 25, 2024
• Study Completion: April 30, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share