Hemiplegic Cerebral PalsyNCT05062122
The Effects of Vibration and Kinesiology Tape Applications in Children With Hemiplegic Cerebral Palsy
An observational study of Hemiplegic Cerebral Palsy, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- vibration group and kinesiology tape group
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Karma Special Education and Rehabilitation Center
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- vibration group, kinesiology tape group, control group
- Keywords
- cerebral palsy, kinesio tape, physiotherapy, vibration
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibration groupOther
Hand skills were evaluated before and after 10 minutes of vibration application.
kinesiology tape groupOther
Dexterity was assessed before and after kinesiology tape application.
control groupOther
Manual dexterity was assessed before and after traditional physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| vibration group | Vibration applied group in addition to conventional physiotherapy Receives: Other: vibration group | |
| kinesiology tape group | The group in which kinesiology tape was applied in addition to conventional physiotherapy Receives: Other: kinesiology tape group | |
| control group | Group receiving only conventional physiotherapy Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole Peg Test (DDPT)
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.
Measured: 10 months
Wooden Box and Block Test (TKBT)
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.
Measured: 10 months
Secondary outcomes (3)
Manual Skills Classification System (EBSS)
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.
Measured: 10 months
Modified Ashworth Scale (MAS)
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).
Measured: 10 months
ABILHAND-Kids Manual Ability Scale
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).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Oct 2021
- Primary completion30 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyzanur Dikmen, Kırıkkale University
- Investigators
- Beyzanur Dikmen, Study director, Graduate student at Kırıkkale UniversityMeral Sertel, Study chair, Associate professor at Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062122
- Sponsor's protocol ID
- kırıkkaleuniversity10
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05062122
- Acronym / sponsor ID
- kırıkkaleuniversity10
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- cerebral palsy, kinesio tape, physiotherapy, vibration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vibration group | – | Other: vibration groupVibration applied group in addition to conventional physiotherapy |
| kinesiology tape group | – | Other: kinesiology tape groupThe group in which kinesiology tape was applied in addition to conventional physiotherapy |
| control group | – | Other: control groupGroup receiving only conventional physiotherapy |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibration groupHand skills were evaluated before and after 10 minutes of vibration application. | Other | vibration group |
| kinesiology tape groupDexterity was assessed before and after kinesiology tape application. | Other | kinesiology tape group |
| control groupManual dexterity was assessed before and after traditional physiotherapy. | Other | control group |
Primary outcome
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.
Wooden Box and Block Test (TKBT)
Time frame: 10 months
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.
3 secondary outcomes
Manual Skills Classification System (EBSS)
Time frame: 10 months
Modified Ashworth Scale (MAS)
Time frame: 10 months
ABILHAND-Kids Manual Ability Scale
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beyzanur Dikmen study director
Graduate student at Kırıkkale University
Meral Sertel study chair
Associate professor at Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegic Cerebral Palsy, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (DDPT) (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.