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Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
kinesiotaping
wrist wheel
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ranged from six to eight years.
  • Diagnosed as HCP.
  • Children with mild upper limb spasticity in all upper limb muscles (grades 1 to 1+) according to modified Ashworth scale.
  • Children had impaired hand functions level II and III according to Manual Ability Classification System.
  • They had the ability to follow simple verbal commands regarding assessment and treatment

Exclusion Criteria:

  • Sever visual or auditory problems
  • Children with severe sensory at the affected upper limb.
  • Recent orthopedic surgical interference in the affected upper limb in the last six months before the study (Tenotomy or muscle transfer in the affected upper limb)
  • Recent botulinum toxin injection of the affected upper extremity muscles in the last six months before the study.

Sites / Locations

  • Mohamed Abd Elfatah abd El karim IbrahimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

kinesiotaping

wrist wheel

Arm Description

Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant.

Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the patient to easily roll wrist back and forth focusing on the wrist and arm

Outcomes

Primary Outcome Measures

Digital Goniometer used to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.
48 children from both genders participated in this study.They assessed by Digital Goniometer to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Shriners Hospital Upper Extremity Evaluation (SHUEE) used to evaluate the spontaneous use of the involved extremity and evaluate the segmental alignment of the extremity while performing tasks on demand in Children with Hemiparetic Cerebral Palsy.
48 children from both genders participated in this study.They assessed by Shriners Hospital Upper Extremity Evaluation (SHUEE) to evaluate upper extremity functions in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .

Secondary Outcome Measures

Full Information

First Posted
November 2, 2021
Last Updated
February 11, 2022
Sponsor
Cairo University
Collaborators
Ministry of Health and Population, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05238259
Brief Title
Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
Official Title
Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Ministry of Health and Population, Egypt

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
Investigate the effect of wrist wheel exercise on ROM of forearm supination and its reflection on upper extremity functions of children with HCP and Compare between effects of kinesiotaping and wrist wheel on ROM of forearm supination and its reflection on upper extremity functions of children with HCP
Detailed Description
Hemiparetic CP affects one side of the body, typically with marked involvement of the upper extremity, and is associated with reduced selective motor control and limited forearm supination . Hemiparetic child has a significant reduction of the effective use of the arm and hand in ADL (e.g. drinking, eating, accomplishing self-care, combing hair or dressing), and their participation at home, school, and later vocational roles . Finding a therapeutic modality to improve ROM of forearm supination is an issue of concern in this study as a child uses varying degrees of supination throughout the day to complete simple activities. Some tasks only involve a person to use half of their supination ROM (e.g: clapping hands together) while other activities require a person to supinate through their full ROM (e.g: carrying a lunch tray). Hemiparetic child has limited supination movement, therefore this study will be conducted to investigate and compare between the therapeutic outcomes of kinesiotaping and wrist wheel on ROM of forearm supination which is important for upper extremity functions of the children with HCP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kinesiotaping
Arm Type
Other
Arm Description
Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant.
Arm Title
wrist wheel
Arm Type
Other
Arm Description
Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the patient to easily roll wrist back and forth focusing on the wrist and arm
Intervention Type
Device
Intervention Name(s)
kinesiotaping
Intervention Description
Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant.
Intervention Type
Device
Intervention Name(s)
wrist wheel
Intervention Description
Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the pateint to easily roll wrist back and forth focusing on the wrist and arm
Primary Outcome Measure Information:
Title
Digital Goniometer used to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.
Description
48 children from both genders participated in this study.They assessed by Digital Goniometer to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Time Frame
baseline
Title
Shriners Hospital Upper Extremity Evaluation (SHUEE) used to evaluate the spontaneous use of the involved extremity and evaluate the segmental alignment of the extremity while performing tasks on demand in Children with Hemiparetic Cerebral Palsy.
Description
48 children from both genders participated in this study.They assessed by Shriners Hospital Upper Extremity Evaluation (SHUEE) to evaluate upper extremity functions in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ranged from six to eight years. Diagnosed as HCP. Children with mild upper limb spasticity in all upper limb muscles (grades 1 to 1+) according to modified Ashworth scale. Children had impaired hand functions level II and III according to Manual Ability Classification System. They had the ability to follow simple verbal commands regarding assessment and treatment Exclusion Criteria: Sever visual or auditory problems Children with severe sensory at the affected upper limb. Recent orthopedic surgical interference in the affected upper limb in the last six months before the study (Tenotomy or muscle transfer in the affected upper limb) Recent botulinum toxin injection of the affected upper extremity muscles in the last six months before the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abd Elfatah
Phone
01025140047
Email
mohafh92@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Salah
Facility Information:
Facility Name
Mohamed Abd Elfatah abd El karim Ibrahim
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
manal salah

12. IPD Sharing Statement

Citations:
PubMed Identifier
28435631
Citation
Shamsoddini A, Rasti Z, Kalantari M, Hollisaz MT, Sobhani V, Dalvand H, Bakhshandeh-Bali MK. The impact of Kinesio taping technique on children with cerebral palsy. Iran J Neurol. 2016 Oct 7;15(4):219-227.
Results Reference
background
PubMed Identifier
29201123
Citation
Allah RASTIl Z, Shamsoddini A, Dalvand H, Labaf S. The Effect of Kinesio Taping on Handgrip and Active Range of Motion of Hand in Children with Cerebral Palsy. Iran J Child Neurol. 2017 Fall;11(4):43-51.
Results Reference
background

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Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy

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