NCT05062122

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

March 14, 2023

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 5, 2021

Last Update Submit

March 10, 2023

Conditions

Keywords

cerebral palsykinesio tapephysiotherapyvibration

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 months

Secondary Outcomes (3)

  • Manual Skills Classification System (EBSS)

    10 months

  • Modified Ashworth Scale (MAS)

    10 months

  • ABILHAND-Kids Manual Ability Scale

    10 months

Study Arms (3)

vibration group

Vibration applied group in addition to conventional physiotherapy

Other: vibration group

kinesiology tape group

The group in which kinesiology tape was applied in addition to conventional physiotherapy

Other: kinesiology tape group

control group

Group receiving only conventional physiotherapy

Other: control group

Interventions

Hand skills were evaluated before and after 10 minutes of vibration application.

vibration group

Dexterity was assessed before and after kinesiology tape application.

kinesiology tape group

Manual dexterity was assessed before and after traditional physiotherapy.

control group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Karma Special Education and Rehabilitation Center

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Beyzanur Dikmen

    Graduate student at Kırıkkale University

    STUDY DIRECTOR
  • Meral Sertel

    Associate professor at Kırıkkale University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

September 5, 2021

First Posted

September 30, 2021

Study Start

October 1, 2021

Primary Completion

December 30, 2021

Study Completion

January 30, 2022

Last Updated

March 14, 2023

Record last verified: 2022-09

Locations