- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05062122
The Effects of Vibration and Kinesiology Tape Applications in Children With Hemiplegic Cerebral Palsy
March 10, 2023 updated by: Beyzanur Dikmen, Kırıkkale University
Evaluation of the Effects of Vibration and Kinesiology Tape Applications Applied to the Affected Side Forearm Extensor Muscles on Hand Skills in Children With Hemiplegic Cerebral Palsy
The aim of this study was to evaluate the effects of vibration and kinesiology tape applications applied to the affected side forearm extensor muscles on dexterity in children with hemiplegic cerebral palsy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Upper extremity in children with hemiplegic cerebral palsy significantly more affected than the lower extremities.
Child mostly does not use the affected side and activity and weight uses the solid side in the overlay. in the upper extremity One of the muscles most affected by spasticity is the wrist and wrist.
finger flexors.
Secondary in antagonist of these muscles weakness develops and posture disorders occur.
In this study The kinesiology tape, which has been increasingly used in recent years, affected by the application and local vibration application.
hand with application to the lateral forearm extensor muscle group comparing their effects on their skills with the control group.
aimed to evaluate.
As a result of the study, this diagnosis hand skills of which application in children who are studying has a greater effect on and in which rehabilitation that the application should be preferred more It will be a guide for physiotherapists.
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Private Karma Special Education and Rehabilitation Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Able to take basic commands between the ages of 4 and 18
1, 2, 3 according to the Manual Ability Classification System Children with hemiplegic cerebral palsy with a value of 0, 1, 1+, 2 on the Modified Ashworth Scale
Description
Inclusion Criteria:
- Diagnosed with hemiplegic cerebral palsy,
- No severe spasticity that prevents grasping and releasing an object (Modified which is at the level of 0, 1, 1+, 2 according to the Ashworth Scale),
- According to the Hand Skills Classification System (EBSS) at 1, 2 and 3 levels with function,
- Consisting of children between the ages of 4-18,
- Being treated in a special education and rehabilitation center,
- The family accepts the participation of their child in the study.
- They are children who have the mental level to take basic commands.
Exclusion Criteria:
- Having severe mental retardation that prevents communication and taking basic commands,
- The family does not accept the child to work,
- Severe spasticity that prevents grasping an object (Modified Ashworth 3 and 4 levels according to the scale),
- Hand function at 4 and 5 levels according to the Hand Skills Classification System (EBSS) the one which,
- Compliance and behavior during the application of the tests used to obtain the data are children with the disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
vibration group
Vibration applied group in addition to conventional physiotherapy
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Hand skills were evaluated before and after 10 minutes of vibration application.
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kinesiology tape group
The group in which kinesiology tape was applied in addition to conventional physiotherapy
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Dexterity was assessed before and after kinesiology tape application.
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control group
Group receiving only conventional physiotherapy
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Manual dexterity was assessed before and after traditional physiotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nine Hole Peg Test (DDPT)
Time Frame: 10 months
|
DDPT is a standard-sized nine-hole panel.
Nine nails made of simple, performance-enhancing material is a time-tested test of fine upper motor function.
To counter the learning effect, the child was allowed to experience this test.
Before the start of the test, the test procedure is explained as quickly as possible.
After inserting wooden nails into the holes in the same way and placing all 9 nails into the holes, the nails were asked to be removed without waiting.
Test completion time recorded with the stopwatch.
The stopwatch was stopped when the last nail was removed and placed in the side chamber, and the time displayed on the stopwatch was recorded.
The completion time of the test gave information about the person's upper extremity performance.
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10 months
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Wooden Box and Block Test (TKBT)
Time Frame: 10 months
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CBCT is used to evaluate manual dexterity in patients with stroke, multiple sclerosis, traumatic brain injury, fibromyalgia, children with upper extremity involvement, and the elderly.
While the test is seated in a chair with a backrest without armrests, supported by the feet, the affected side to be evaluated is conventionally positioned with the hand.
It was performed before and after the application in addition to physiotherapy.
First, a trial period of 15 seconds was given.
Then, he was asked to fill 150 small wooden blocks one by one as fast as possible for 60 seconds from the box with the hand to be tested to the box next to it.
If he throws it without raising his hand, it will not be counted, accidentally 2 It was stated that if he throws a wooden block, it will be counted as 1 wooden block.
It was counted how many wooden blocks were thrown in 60 seconds and the result gave information about the upper extremity performance tested.
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10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manual Skills Classification System (EBSS)
Time Frame: 10 months
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The EBSS was a five-level, ordinal classification system that described the manual dexterity of children with CP aged 4 to 18 years when handling objects in typical daily activities.
EBSS levels define the use of both hands in daily activities, which is expected according to a child's age, not only as a fine motor function, but also as dependent on cognitive, motor planning and motivation.
EBSS is not an outcome measure or diagnostic tool, its purpose is a child's daily classifying the ability to use objects manually in life.
EBSS level 1 represents the highest level of manual ability at which objects can be grasped and used easily and successfully, and level 5 represents the lowest level where objects cannot be used independently and assistance is most needed.
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10 months
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Modified Ashworth Scale (MAS)
Time Frame: 10 months
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The MAS is the most universally accepted clinical tool used to measure the increase in muscle tone.
In 1964, Bryan Ashworth published the Ashworth Scale as a method of grading spasticity while working with multiple sclerosis patients.
The original Ashworth scale was 0-4, 0 without resistance, and 4 for spasticity.
It is a 5-point numerical scale with limb stiffness in flexion or extension.
In 1987, manual testing of elbow flexor muscle spasticity, Bohannon and Smith, while conducting a study to examine inter-interpretive reliability, modified the Ashworth scale to add 1+ to the scale to increase sensitivity.
The purpose of the modified Ashworth scale is to assess muscle tone.
It is easy to use, but the findings are subject to the subjective opinion of the evaluator.
This scale classifies muscle tone from 0 (normal) to 4 (severe spasticity).
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10 months
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ABILHAND-Kids Manual Ability Scale
Time Frame: 10 months
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ABILHAND Kids, developed by Rasch in 2004, is a reliable, valid and sensitive measure for assessing manual dexterity in children with upper extremity disorders.
ABILHAND-Kids is a convenient and fast-applied scale consisting of 21 items covering various areas of daily life.
Often the function of both hands is evaluated.
Generally, the scale is applied by asking the families, if the child is older and at a level to be able to apply the scale, he/she can be included in the application.
While assessing functional ability, any assistive device or There should be no human support.
For each item, they are asked to indicate their perceived difficulty on a three-level scale: Impossible (0 point), Difficult (1 point), or Easy (2 points).
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10 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Beyzanur Dikmen, Graduate student at Kırıkkale University
- Study Chair: Meral Sertel, Associate professor at Kırıkkale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
December 30, 2021
Study Completion (Actual)
January 30, 2022
Study Registration Dates
First Submitted
September 5, 2021
First Submitted That Met QC Criteria
September 20, 2021
First Posted (Actual)
September 30, 2021
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- kırıkkaleuniversity10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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