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Reciprocal Electrical Stimulation Versus Kinesio Taping

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electrical stimulation device
kinesio taping
Sponsored by
Basma Elsaid Mahmoud Bakr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring kinesio taping, reciprocal electrical stimulation

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A medical diagnosis of spastic hemiplegic CP made by paediatricians or pediatric neurologists. Children with spasticity grades ranged from 1 to 1+ according to MAS. Their age range from 4 to 6 years. Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques Exclusion Criteria: They had a permanent deformity (bony or soft tissue contractures). Children having visual or auditory defects. Children with intelligence quotient less than 70. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand. A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods. Children who are absent in two taping change sessions

Sites / Locations

  • Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (A)

Group (B)

Arm Description

will receive RES in addition to the traditional exercise program.

will receive KT in addition to the traditional exercise program.

Outcomes

Primary Outcome Measures

Fine motor skills
we will use Peabody developmental motor scale-2 to assess fine motor skills

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
August 11, 2023
Sponsor
Basma Elsaid Mahmoud Bakr
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1. Study Identification

Unique Protocol Identification Number
NCT05799703
Brief Title
Reciprocal Electrical Stimulation Versus Kinesio Taping
Official Title
Effect Of Reciprocal Electrical Stimulation Versus Kinesio Taping On Hand Functions In Hemiparetic Cerebral Palsy Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Basma Elsaid Mahmoud Bakr

4. Oversight

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

5. Study Description

Brief Summary
This study will be conducted to: evaluate the effect of kinesio taping on hand functions in hemiplegic cerebral palsy children compare between the effects of reciprocal electrical stimulation and kinesio taping on hand functions in hemiplegic cerebral palsy children.
Detailed Description
A. Patients preparation All the children demographic and outcome measures data will be collected in specially well-designed sheets1. Evaluation of fine motor skills using PDMS-2 Evaluation of hand function using Besta scale . The traditional exercise program (given to both groups): Treatment protocol in Group A, Reciprocal electrical stimulation protocol The device has two channels that can stimulate two opposing groups of muscles alternatively (reciprocate). During ES, the child sits in a chair with his treated forearm resting on a pillow placed on the bed in front of him. The electrodes will be placed as follows: Channel 1 (stimulates wrist and hand extensors) electrodes placed over the dorsum of the forearm as follows: the active electrode is placed over the common extensor origin, while in different over the motor point of extensor pollicis longus, abductor pollicis longus, and extensor indices. Channel 2 (stimulates wrist and hand flexors) electrodes placed on the palmar side of the forearm are as follows: the negative electrode is placed between the finger flexors and wrist flexors. The positive electrode is placed over the tendonportion of the forearm, The treatment duration will be 20 minutes. The treatment protocol will be repeated 3 times per week for 12 weeks. Treatment protocol in Group B, Kinesio taping protocol: Kinesio taping will be applied on both sides of the upper limb. The applied area will be from the proximal one-third of the forearm to the wrist and then will be split into 5 straps into the distal interphalangeal joint of fingers. On the dorsal side, KT will be applied on the forearm, wrist, and fingers extensors for improvement of wrist and fingers extension. On the plantar side, KT will be applied on the forearm, wrist, and fingers flexors for inhibition of wrist and fingers flexion. Taping will be applied for 6 days, 24 h a day, on the affected upper limb, and it will be removed for only one day per week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
kinesio taping, reciprocal electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Active Comparator
Arm Description
will receive RES in addition to the traditional exercise program.
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
will receive KT in addition to the traditional exercise program.
Intervention Type
Device
Intervention Name(s)
electrical stimulation device
Intervention Description
the device has 2 channels ,4 electrodes with multiple ems programs
Intervention Type
Other
Intervention Name(s)
kinesio taping
Intervention Description
kinesio tape a therapeutic tape that's applied strategically to the body to provide support, lessen pain, reduce swelling, and improve performance
Primary Outcome Measure Information:
Title
Fine motor skills
Description
we will use Peabody developmental motor scale-2 to assess fine motor skills
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A medical diagnosis of spastic hemiplegic CP made by paediatricians or pediatric neurologists. Children with spasticity grades ranged from 1 to 1+ according to MAS. Their age range from 4 to 6 years. Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques Exclusion Criteria: They had a permanent deformity (bony or soft tissue contractures). Children having visual or auditory defects. Children with intelligence quotient less than 70. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand. A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods. Children who are absent in two taping change sessions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basma Bakr, bachelor's
Phone
01010967210
Ext
+20
Email
basmabakr2017@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
nesma barakat
Facility Information:
Facility Name
Physical Therapy
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Reciprocal Electrical Stimulation Versus Kinesio Taping

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