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

NCT05727826 | Unknown

• 1 other identifier: SMV on stroke patient
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Box and block test (BBT)

  Box and block test (BBT) which is used to assess unilateral gross manual dexterity and functional abilities of upper extremity specifically for hand and wrist functionality. A simple, quick, and inexpensive test, it takes only a few minutes to complete. In the BBT, a wooden box is divided into two compartments by a partition, and 150 blocks are placed inside. During BBT administration, the patient is position at the table and asked to move as many blocks as possible in 60 seconds between two individual compartments which are equal in size. A client's score is determined by the number of blocks transferred between compartments within 60 seconds. The scores for each hand should be kept separately. Better manual dexterity is reflected in higher scores. When the BBT is being conducted, the evaluator should be aware of whether the client's fingertips cross the partition. In order to count blocks, this condition must be met.

  60 seconds

Secondary Outcomes (1)

• Visual Analogue Scale (VAS)

  2 minutes

Other Outcomes (1)

• monofilament test

  5 minutes

Study Arms (1)

stroke patients

EXPERIMENTAL

individuals with hemiplegia after Hemorrhagic or Infarction stroke

Device: Thrive MD-01 .

Interventions

Thrive MD-01 . DEVICE

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

stroke patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other neurological problems, Parkinson's

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe university

Istanbul, Ataşahir, 34755, Turkey (Türkiye)

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hager E Yahya, Mcs

CONTACT

5527913211; hageryahya13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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%.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 14, 2023
• Study Start: March 2, 2023
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-01

Locations

TU (1)