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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thrive MD-01 .
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeditepe universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stroke patients

Arm Description

individuals with hemiplegia after Hemorrhagic or Infarction stroke

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is used to measure the severity of pain in patients, it can also be useful at recording patients' pain progression, or compare pain severity between individuals with similar conditions.

Full Information

First Posted
January 23, 2023
Last Updated
February 13, 2023
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05727826
Brief Title
The Investigation of the Effectiveness of Vibratory Stimulation on Upper Limb Function, Pain and Sensation in Patients With Stroke.
Official Title
The Investigation of the Effectiveness of Vibratory Stimulation on Upper Limb Function, Pain and Sensation in Patients With Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Anticipated)
Primary Completion Date
May 26, 2023 (Anticipated)
Study Completion Date
May 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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%.
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stroke patients
Arm Type
Experimental
Arm Description
individuals with hemiplegia after Hemorrhagic or Infarction stroke
Intervention Type
Device
Intervention Name(s)
Thrive MD-01 .
Intervention Description
The experimental group received a 60 Hz vibration stimulation treatment using the SMV method three times per week for two weeks (EG).
Primary Outcome Measure Information:
Title
Box and block test (BBT)
Description
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.
Time Frame
60 seconds
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS) is used to measure the severity of pain in patients, it can also be useful at recording patients' pain progression, or compare pain severity between individuals with similar conditions.
Time Frame
2 minutes
Other Pre-specified Outcome Measures:
Title
monofilament test
Description
In the evaluation of light touch and pressure protective senses, monofilament is used to test sensory levels and detect diminishing and returning senses. This evaluation should be carried out in a very systematic manner. The therapist begins with the smallest monofilament and progresses to the largest filament in the correct order, but the test is stopped and the value is recorded when the patient detects the smallest monofilament being tested. It is applied to the anterior and posterior surfaces of the fingers from the first to the fifth, distal to proximal. This evaluation tool is made up of a series of monofilaments that vary in thickness and diameter. These monofilaments have gradient strengths ranging from 0.086 gm to 448 gm. These monofilaments are used to assess sensory impairment.
Time Frame
5 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hager E Yahya, Mcs
Phone
5527913211
Email
hageryahya13@gmail.com
Facility Information:
Facility Name
Yeditepe university
City
Istanbul
State/Province
Ataşahir
ZIP/Postal Code
34755
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif T Çil, Phd
Phone
02165780000
Email
elif.cil@yeditepe.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5599834/
Description
Related Info

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

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