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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05799703
Other study ID # EG, KFS lab Research 6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date October 30, 2023

Study information

Verified date March 2024
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be conducted to: 1. evaluate the effect of kinesio taping on hand functions in hemiplegic cerebral palsy children 2. compare between the effects of reciprocal electrical stimulation and kinesio taping on hand functions in hemiplegic cerebral palsy children.


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): 1. 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. 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 30, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
electrical stimulation device
the device has 2 channels ,4 electrodes with multiple ems programs
Other:
kinesio taping
kinesio tape a therapeutic tape that's applied strategically to the body to provide support, lessen pain, reduce swelling, and improve performance

Locations

Country Name City State
Egypt Physical Therapy Kafr Ash Shaykh Kafrelsheikh

Sponsors (1)

Lead Sponsor Collaborator
Basma Elsaid Mahmoud Bakr

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fine motor skills we will use Peabody developmental motor scale-2 to assess fine motor skills 3 months
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