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The Effect of Vibration Applied on Forearm Extensor Muscles Patients With Stroke

Primary Purpose

Stroke Patients

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Routine conventional physical therapy plus Vibration session
Routine conventional physical therapy
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Patients focused on measuring Stroke, Rehabilitation, Vibration, Hand functions, Forearm extensor muscle

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with stroke
  • Cognitive and without communication problems
  • Patients with active movement in the upper extremities

Exclusion Criteria:

  • People who have undergone botulinum toxin application to the upper extremity
  • Significant cognitive impairment that will interfere with functional evaluation
  • Deformity and / or contracture in the upper extremity due to fractures, inflammatory arthropathy, etc.
  • Infection, skin lesion or hematoma at the application site

Sites / Locations

  • Ayşe Abit Kocaman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibration Group

Control Group

Arm Description

Routine conventional physical therapy will be applied to patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, right after the sessions, 3 days a week, 30 Hz. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest.

Routine conventional physical therapy will be applied to the control group in 4 weeks and 60 minute sessions.

Outcomes

Primary Outcome Measures

EMG measurement
Muscular activation of the forearm extensor group muscles will be measured with the Electromyography device. Electromyography measurements will be measured before and after application of vibration. In electromyography measurements, active electrodes will be placed in the motor point of the muscle, and passive electrode will be placed on any muscle body in the other arm, three times measurement will be made and average values will be recorded. Surface electrodes will be used. The measurements will be recorded as the individual attempts to flex the wrist. While measuring, the volunteers will be ensured to take a comfortable position. Muscular activation; Surface electromyography data will be recorded using "Myomonitor Wireless Electromyography Systems" Delsys branded Electromyography device. The conductivity band of the electromyography amplifier is 20-450 Hz, its gain is 1000 Hz, and the average noise recovery rate is> 80 decibel.

Secondary Outcome Measures

Wolf Motor Function Test
Wolf Motor Function Test : Test is an evaluation developed to evaluate motor skill in patients with moderate to severe upper extremity motor deficits. For 15 activities, data are collected in two areas as "Functional Skills" and "Performance Time". The other two items are evaluated on activity muscle strength. Using the "functional skill scale", each activity is evaluated by the physiotherapist between 0-5 points (0 = Never used the affected hand during activity, 5 = Normal movement). The average score is calculated for the functional skill scale. Accordingly, the patient can score in the range of 0-5 points from this evaluation, and a high score indicates good functional skills. "Performance Time" is recorded in seconds. The maximum time allowed for an activity to be completed is 120 seconds. Performance time is also recorded as 120 seconds for activities that cannot be completed during this period.
Functional independence scale
Functional independence scale was used to evaluate the independence of the patients in daily living activities. It is a global activity scale that shows how independent a person is in their daily basic physical and cognitive activities. The functional independence scale includes 18 items and basically measures in 2 areas. The first is physical motor function (13 items), the second is cognitive / cognitive function (5 items). 4 of the items that make up the functional independence scale are in the physical and 2 in the cognitive domain. There are 6 items on self-care, 2 items on sphincter control, 3 items on mobility, 2 items on locomotion, 2 items on communication and 3 items on social perception. Each item is scored at seven levels, "level 1" indicates full assistance, and "level 7" indicates complete independence.

Full Information

First Posted
September 18, 2020
Last Updated
October 24, 2021
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04562220
Brief Title
The Effect of Vibration Applied on Forearm Extensor Muscles Patients With Stroke
Official Title
The Effect of Vibration Applied on Forearm Extensor Muscles on Hand Functions and Muscle Activation in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
January 24, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

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

5. Study Description

Brief Summary
This study was planned to determine the effect of vibration applied to forearm extensor muscles on hand functions and muscle activation in stroke patients.
Detailed Description
Patients will be included in our study, who will be hospitalized in Kirikkale University Faculty of Medicine Physical Therapy Hospital and will receive stroke rehabilitation. The number of patients will be determined to be approximately 24 according to the power analysis. Patients meeting the inclusion criteria and excluding the exclusion criteria will be randomized according to the order of arrival and divided into 2 groups as the training group and the control group. Patients will be randomized using block randomization. Routine conventional physical therapy will be applied to the patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, 30 Hz, 3 days a week, immediately after the sessions, to the forearm extensor group muscles with ''Conformité Européene'' certified vibration device. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest. Routine conventional physical therapy will be applied to the control group in 4 weeks and 45 minute sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
Stroke, Rehabilitation, Vibration, Hand functions, Forearm extensor muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibration Group
Arm Type
Experimental
Arm Description
Routine conventional physical therapy will be applied to patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, right after the sessions, 3 days a week, 30 Hz. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Routine conventional physical therapy will be applied to the control group in 4 weeks and 60 minute sessions.
Intervention Type
Other
Intervention Name(s)
Routine conventional physical therapy plus Vibration session
Intervention Description
Routine conventional physical therapy will be applied to patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, right after the sessions, 3 days a week, 30 Hz. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest.
Intervention Type
Other
Intervention Name(s)
Routine conventional physical therapy
Intervention Description
Routine conventional physical therapy will be applied to the control group in 4 weeks and 60 minute sessions
Primary Outcome Measure Information:
Title
EMG measurement
Description
Muscular activation of the forearm extensor group muscles will be measured with the Electromyography device. Electromyography measurements will be measured before and after application of vibration. In electromyography measurements, active electrodes will be placed in the motor point of the muscle, and passive electrode will be placed on any muscle body in the other arm, three times measurement will be made and average values will be recorded. Surface electrodes will be used. The measurements will be recorded as the individual attempts to flex the wrist. While measuring, the volunteers will be ensured to take a comfortable position. Muscular activation; Surface electromyography data will be recorded using "Myomonitor Wireless Electromyography Systems" Delsys branded Electromyography device. The conductivity band of the electromyography amplifier is 20-450 Hz, its gain is 1000 Hz, and the average noise recovery rate is> 80 decibel.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Wolf Motor Function Test : Test is an evaluation developed to evaluate motor skill in patients with moderate to severe upper extremity motor deficits. For 15 activities, data are collected in two areas as "Functional Skills" and "Performance Time". The other two items are evaluated on activity muscle strength. Using the "functional skill scale", each activity is evaluated by the physiotherapist between 0-5 points (0 = Never used the affected hand during activity, 5 = Normal movement). The average score is calculated for the functional skill scale. Accordingly, the patient can score in the range of 0-5 points from this evaluation, and a high score indicates good functional skills. "Performance Time" is recorded in seconds. The maximum time allowed for an activity to be completed is 120 seconds. Performance time is also recorded as 120 seconds for activities that cannot be completed during this period.
Time Frame
45 minutes
Title
Functional independence scale
Description
Functional independence scale was used to evaluate the independence of the patients in daily living activities. It is a global activity scale that shows how independent a person is in their daily basic physical and cognitive activities. The functional independence scale includes 18 items and basically measures in 2 areas. The first is physical motor function (13 items), the second is cognitive / cognitive function (5 items). 4 of the items that make up the functional independence scale are in the physical and 2 in the cognitive domain. There are 6 items on self-care, 2 items on sphincter control, 3 items on mobility, 2 items on locomotion, 2 items on communication and 3 items on social perception. Each item is scored at seven levels, "level 1" indicates full assistance, and "level 7" indicates complete independence.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with stroke Cognitive and without communication problems Patients with active movement in the upper extremities Exclusion Criteria: People who have undergone botulinum toxin application to the upper extremity Significant cognitive impairment that will interfere with functional evaluation Deformity and / or contracture in the upper extremity due to fractures, inflammatory arthropathy, etc. Infection, skin lesion or hematoma at the application site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Abit Kocaman
Organizational Affiliation
Kırıkkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayşe Abit Kocaman
City
Kırıkkale
ZIP/Postal Code
7110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25169762
Citation
Pamukoff DN, Ryan ED, Blackburn JT. The acute effects of local muscle vibration frequency on peak torque, rate of torque development, and EMG activity. J Electromyogr Kinesiol. 2014 Dec;24(6):888-94. doi: 10.1016/j.jelekin.2014.07.014. Epub 2014 Aug 7.
Results Reference
background
PubMed Identifier
15895663
Citation
Kasman G. Using surface electromyography. Rehab Manag. 2001 Dec-2002 Jan;14(9):56-9, 76. No abstract available.
Results Reference
background
PubMed Identifier
11387578
Citation
Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
Results Reference
background
PubMed Identifier
5900183
Citation
Wang MZ, Chow TW. [Determination of diosgenin in plants]. Yao Xue Xue Bao. 1964;11(4):235-41. No abstract available. Chinese.
Results Reference
background
Citation
D Geler Külcü, B Yanık, G Gülşen - The relationship between balance disorders and upper extremity function in hemiplegic patients.J PMR Sci, 2009.
Results Reference
result

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The Effect of Vibration Applied on Forearm Extensor Muscles Patients With Stroke

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