NCT06157489

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 27, 2023

Last Update Submit

November 27, 2023

Conditions

Dysphagia, Oropharyngeal, Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Oral motor assessment sacle

    Assessment for oral phase

    1 month

Secondary Outcomes (1)

  • ultrasonography

    1 month

Study Arms (15)

Hamza

ACTIVE COMPARATOR
Other: Kinesio tape

Noor mohamed

SHAM COMPARATOR
Other: Kinesio tape

Janna ahmed

ACTIVE COMPARATOR
Other: Kinesio tape

Hamza salah

ACTIVE COMPARATOR
Other: Kinesio tape

Mohammed asel

SHAM COMPARATOR
Other: Kinesio tape

Ali ahmed

ACTIVE COMPARATOR
Other: Kinesio tape

Malek Mohamed

SHAM COMPARATOR
Other: Kinesio tape

Sayed Mohamed

ACTIVE COMPARATOR
Other: Kinesio tape

Omar ahmed

ACTIVE COMPARATOR
Other: Kinesio tape

Ahmed Mohamed

SHAM COMPARATOR
Other: Kinesio tape

Yousef salah

SHAM COMPARATOR
Other: Kinesio tape

Rofan ahmed

ACTIVE COMPARATOR
Other: Kinesio tape

Kinesio tape hasnot assigned to arm group Exercise only

SHAM COMPARATOR
Other: Kinesio tape

Fareda salah

ACTIVE COMPARATOR
Other: Kinesio tape

Abd elrahman ahmed

ACTIVE COMPARATOR
Other: Kinesio tape

Interventions

Kinesio tapeOTHER

Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle

Abd elrahman ahmedAhmed MohamedAli ahmedFareda salahHamzaHamza salahJanna ahmedKinesio tape hasnot assigned to arm group Exercise onlyMalek MohamedMohammed aselNoor mohamedOmar ahmedRofan ahmedSayed MohamedYousef salah

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children will be excluded if they have any of the following criteria:
  • Severe visual and auditory problems.
  • History of maxillary, head or neck surgical procedures.
  • Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadeer samy abd elaziz

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Deglutition DisordersCerebral Palsy

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Central Study Contacts

Hadeer Samy Abd elaziz

CONTACT

01097917913hadeersamypt@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Active Comparator: Kinesiotape Group In active group, KT was applied in masseter muscle, orbicularis oris and infrahyoid muscles for facilitating suprahyoid muscle and oral sensorimotor exercise In sham group will receive the oral sensorimotor exercise only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 5, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations

EG(1)