Effect of Kinesio Tape on Oral and Pharangeal Swallowing Phases in Children With Spastic Cerebral Palsy

The purpose of current study is to investigate the effect of kinesio tape in children with spastic cerebral palsy having oropharyngeal dysphagia

Study Overview

• Status: Recruiting
• Conditions: Dysphagia, Oropharyngeal, Cerebral Palsy
• Intervention / Treatment: Other: Kinesio tape

Detailed Description

The study tageted rhe children with spastic cerebral palsy from both sexes will be selected from hospital of Tanta university

Inclusion criteria:

1. Age ranges from 2 to 7 years.
2. The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
3. Diagnosed as spastic diplegia or quadriplegia.
4. Able to understand and follow instructions.

Exclusion criteria:

Children will be excluded if they have any of the following criteria:

1. Severe visual and auditory problems.
2. History of maxillary, head or neck surgical procedures.
3. Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadeer Samy Abd elaziz; Phone Number: Samy 01097917913; Email: hadeersamypt@gmail.com

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Hadeer samy abd elaziz
    • Contact: Hadeer Samy Abd elaziz; Phone Number: 01097917913; Email: hadeersamypt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ranges from 3 to 7 years.
2. The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
3. Diagnosed as spastic diplegia or quadriplegia.
4. Able to understand and follow instructions.

Exclusion Criteria:

Children will be excluded if they have any of the following criteria:

1. Severe visual and auditory problems.
2. History of maxillary, head or neck surgical procedures.
3. Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hamza	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Sham Comparator: Noor mohamed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Janna ahmed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Hamza salah	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Sham Comparator: Mohammed asel	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Ali ahmed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Sham Comparator: Malek Mohamed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Sayed Mohamed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Omar ahmed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Sham Comparator: Ahmed Mohamed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Sham Comparator: Yousef salah	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Rofan ahmed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Sham Comparator: Kinesio tape hasnot assigned to arm group Exercise only	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Fareda salah	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
Active Comparator: Abd elrahman ahmed	Other: Kinesio tape; Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral motor assessment sacle	Assessment for oral phase	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasonography	Assessment of pharangal phase	1 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Estimated): December 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Cerebral Palsy; Deglutition Disorders
• Other Study ID Numbers: 004448

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No