NCT04562220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

September 18, 2020

Last Update Submit

October 24, 2021

Conditions

Keywords

StrokeRehabilitationVibrationHand functionsForearm extensor muscle

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Secondary Outcomes (2)

  • Wolf Motor Function Test

    45 minutes

  • Functional independence scale

    15 minutes

Study Arms (2)

Vibration Group

EXPERIMENTAL

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.

Other: Routine conventional physical therapy plus Vibration session

Control Group

ACTIVE COMPARATOR

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

Other: Routine conventional physical therapy

Interventions

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.

Vibration Group

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

Control Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Abit Kocaman

Kırıkkale, 7110, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 25169762BACKGROUND
  • Kasman G. Using surface electromyography. Rehab Manag. 2001 Dec-2002 Jan;14(9):56-9, 76. No abstract available.

    PMID: 15895663BACKGROUND
  • 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.

    PMID: 11387578BACKGROUND
  • Wang MZ, Chow TW. [Determination of diosgenin in plants]. Yao Xue Xue Bao. 1964;11(4):235-41. No abstract available. Chinese.

    PMID: 5900183BACKGROUND
  • D Geler Külcü, B Yanık, G Gülşen - The relationship between balance disorders and upper extremity function in hemiplegic patients.J PMR Sci, 2009.

    RESULT
  • Abit Kocaman A, Onal B, Sertel M, Karaca G. The effect of local vibration applied to the forearm extensor muscles on hand function and muscle activation in stroke patients: a randomized controlled study. Acta Neurol Belg. 2023 Oct;123(5):1957-1964. doi: 10.1007/s13760-023-02335-6. Epub 2023 Jul 23.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ayşe Abit Kocaman

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 24, 2020

Study Start

September 15, 2020

Primary Completion

January 24, 2021

Study Completion

March 24, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations