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Is Kinesio Taping Treatment Effective in Children With Cerebral Palsy?

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kinesiotaping
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, upper extremity kinesiotaping, modified house

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 6-18
  2. Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current imaginig findings
  3. Patient with stable clinical status
  4. Stage ≤2 patients depended on the modified ascwort scale
  5. Patients who are eligible to participate the study tests with suitable cognitive state
  6. Patients who agreed to participate the study.

Exclusion Criteria:

  1. Stage >2 patients depended on the modified ascwort scale
  2. Botilinum toxin intervention to the upper extremity in the last 6 months.
  3. Patients who undergo upper extremity surgery.
  4. Patients who have contraindication for kinesiotaping (Wide and severe skin injury, open wounds at risk of infection , allergic reactions)
  5. Patients with intense sensory and motor loss in the banding area
  6. Patients classified in stage IIB and above according to Zancolli stage

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kinesiotaping group(before/after)

Arm Description

Hemiplegic CP:Kinesiotaping on the affected side Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary. Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion

Outcomes

Primary Outcome Measures

Box and block test
With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.
Nine hole peg test
A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.

Secondary Outcome Measures

Modified house clasification score
The score obtained from the Modified House Classification is calculated by recording the patient's capabilities among the listed 32 activities
Active/passive wrist dorsiflexion range of motion
With goniometer active/passive wrist dorsiflexion range of motion will be measured.

Full Information

First Posted
January 23, 2019
Last Updated
January 25, 2019
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03819205
Brief Title
Is Kinesio Taping Treatment Effective in Children With Cerebral Palsy?
Official Title
Investıgatıng the Effect of Kinesiotaping on Hand Functions in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
March 10, 2019 (Anticipated)
Study Completion Date
March 10, 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children with CP may present with a variety of motor impairments. The impaired upper limb function of children with cerebral palsy (CP) limits and restricts participation in activities of daily living. Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic and rigid. In fact, there has been a few studies that investigates the effect of upper extremity elastic kinesiotaping. High methodological studies about its efficacy in this population are rare.
Detailed Description
34 Children with cerebral palsy aged between 6-18 applied to Dokuz Eylül Üniversity Medical School Hospital Physical Medicine ve Rehabilitation Department will be included the study. Patients have diagnosed as CP with the subgroup of diplegic, hemiplegic, tetraplegic and mixt. The upper extremity side will be chosen as the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life. The chosen upper extremity side will be taped with the functional correction technique on the dorsum of the hand and forearm by clinician. Patients will be taped at least 2-3 hours a day every day and they will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping patients will be evaluated with box and block test, nine hole peg test, modified house clasification score and the active/passive wrist dorsiflexion range of motion. The investigator will also note the gross motor function clasification system level, dominant hand side and affected side, for chosen upper extremity side's zancolli clasification, modified aschwort scale of wrist and hand fingers, manual ability clasification system level for every patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, upper extremity kinesiotaping, modified house

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
self-controlled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kinesiotaping group(before/after)
Arm Type
Experimental
Arm Description
Hemiplegic CP:Kinesiotaping on the affected side Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary. Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
Intervention Type
Other
Intervention Name(s)
kinesiotaping
Intervention Description
The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
Primary Outcome Measure Information:
Title
Box and block test
Description
With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.
Time Frame
1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Title
Nine hole peg test
Description
A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.
Time Frame
1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Secondary Outcome Measure Information:
Title
Modified house clasification score
Description
The score obtained from the Modified House Classification is calculated by recording the patient's capabilities among the listed 32 activities
Time Frame
1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Title
Active/passive wrist dorsiflexion range of motion
Description
With goniometer active/passive wrist dorsiflexion range of motion will be measured.
Time Frame
1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 6-18 Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current imaginig findings Patient with stable clinical status Stage ≤2 patients depended on the modified ascwort scale Patients who are eligible to participate the study tests with suitable cognitive state Patients who agreed to participate the study. Exclusion Criteria: Stage >2 patients depended on the modified ascwort scale Botilinum toxin intervention to the upper extremity in the last 6 months. Patients who undergo upper extremity surgery. Patients who have contraindication for kinesiotaping (Wide and severe skin injury, open wounds at risk of infection , allergic reactions) Patients with intense sensory and motor loss in the banding area Patients classified in stage IIB and above according to Zancolli stage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeynep Tokel
Phone
+905068535386
Email
zeyneptkl343@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Tokel, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
İ̇zmi̇r
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeynep Tokel, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Is Kinesio Taping Treatment Effective in Children With Cerebral Palsy?

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