The Investigation of the Effectiveness of Vibratory Stimulation on Upper Limb Function, Pain and Sensation in Patients With Stroke.

NCT ID: NCT05727826

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2023-05-26

Brief Summary

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The objectives of this study cover both the vibration stimulation intervention and its outcomes. Patients with stroke frequently experience spasm in both the lower and upper extremities, which impairs sensory perception and motor function. This study aims to evaluate the effects of vibration therapy on the forearm and arm extensors of stroke patients and to report on changes in sensory perception and motor function measures. Although vibration therapy has lately been utilized to treat these limbs, there haven't been enough trials to determine how beneficial it is in the application procedure. This study aims to investigate the outcomes and effectiveness of a vibration therapy program administered to the extensor muscles.

Detailed Description

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One of the major disadvantages is the loss of muscle strength in patients with post-stroke hemiplegia. Muscle weakness is caused after a stroke, followed by limited movement . Tactile and proprioceptive sensations are reduced in up to 65% of hemiplegic patients. Furthermore, pain, temperature, and touch are reduced. Because the ability to perceive these sensory features is impaired, recognizing objects by touch or exploring the environment can be difficult. Furthermore, it is stated that the senses are important and influence the recognition of skilled movements. A disorder has negative consequences for safety, natural hand use, the ability to maintain an appropriate level of strength while grasping without vision, and difficulties with object management. In this way, regaining motor control is a complex and time-consuming process. The increased unmasking of neural covert connections and the number of synapses in dendrites are two mechanisms by which the brain reorganizes itself. It has been observed that functionally relevant adaptive changes occur in the brain following an injury .Segmental muscle vibration (SMV) is a technique that uses a mechanical apparatus to deliver a vibratory stimulus to a specific tendon. As a result of the facilitation of muscle spindle primary ends, SMV provides Ia inputs. By managing intracortical inhibition and activating sensory inputs to the primary motor cortex, Ia sensory inputs facilitated by SMV can alter the activation of the corticospinal pathway. Transcranial magnetic simulation was used in a previous study after low-amplitude SMV was applied to the flexor carpi radialis muscle and inner hand muscles, and increased excitability in the primary motor cortex .While systematic data on improving human somatosensation are lacking, many accounts indicate that there is room for improvement. Furthermore, previous research on lesioned primates has shown that extensive training in touch, proprioception, and vibration improves even the most complex discriminating abilities. It also aided in the identification of the somatosensory cortex. As a result, the purpose of this study was to better understand the pure effect of repeated vibratory stimulation and its long-term effects two weeks after the last intervention session, when compared to the experimental or control groups.

In summary, studies in the literature have used a vibratory stimulation device to perform arm and wrist flexor motion therapy. This will be the first study to look at how vibratory stimulation of the forearm and arm extensor muscles affects upper extremity function, sensation, and pain parameters in hemiplegic patients.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The research subjects were divided into two groups of five, experimental and control. A random number generator was used to generate the groups. The experimental group received a 60 Hz vibration stimulation treatment using the SMV method three times per week for two weeks (EG). The patients were seated on a chair, with the affected arm fixed so that there was no movement during vibration application. Several tests are used to determine the progression of the EG before and after the vibration protocol. These tests include:

The box and block test (BBT) is used to assess unilateral gross manual dexterity and upper extremity functional abilities, specifically hand and wrist functionality. The Visual Analogue Scale (VAS) is used to assess the severity of pain in patients. It can also be used to track patients' pain progression or to compare pain severity between people who have similar conditions. In the evaluation of light touch and pressure protective senses, a monofilament test is used.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

The sample number of the study was calculated with the program named G\*Power 3.1.9.2. The sample size of the study was calculated as 10 in total, with an error of +/-0.5, an effect size of 0.44 calculated for an estimated standard deviation of 1.26, a power of 80% and a margin of error of 5%.

Study Groups

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stroke patients

individuals with hemiplegia after Hemorrhagic or Infarction stroke

Group Type EXPERIMENTAL

Thrive MD-01 .

Intervention Type DEVICE

The experimental group received a 60 Hz vibration stimulation treatment using the SMV method three times per week for two weeks (EG).

Interventions

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Thrive MD-01 .

The experimental group received a 60 Hz vibration stimulation treatment using the SMV method three times per week for two weeks (EG).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* no complaints of pain caused by induced vibration
* \>24 points in Mini Mental State Examination
* Having a diagnosis of hemiplegia

Exclusion Criteria

• Other neurological problems, Parkinson's
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yeditepe university

Istanbul, Ataşahir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hager E Yahya, Mcs

Role: CONTACT

5527913211

Facility Contacts

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Elif T Çil, Phd

Role: primary

02165780000

Related Links

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Other Identifiers

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SMV on stroke patient

Identifier Type: -

Identifier Source: org_study_id

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