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Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia

Primary Purpose

Drooling

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
kinesiotaping therapy
oral motor manipulation therapy
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drooling focused on measuring dysphagia, drooling, kinsesiotaping therapy, manipulation therapy

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Both male and female children with different non degenerative neurological disabilities ( cerebral palsy, traumatice brain injury, childhood stroke) and having oral phase dysphagia.

    • Age between 3-15 years.
    • Those who will have drooling severity rating of ≥ 4 on modified Teacher's drooling scale.
    • Child who can comprehend simple verbal commands and on 3 words sentence level speech
    • Have good head control.
    • Parents and care givers of children with drooling and oral phase dysphagia will also be included in the study

Exclusion Criteria:

  • Those children who would have structural abnormality of respiratory system.
  • Corrected or uncorrected cleft palate or cleft lip.
  • Wounds around the lips.
  • Recent surgery, and medication or on any treatment to control drooling would be excluded from the study.

Sites / Locations

  • Romana PervezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A kinesiotaping therapy

Group B Oral Motor Manipulation therapy

Arm Description

Protocols mentioned in kinesiological taping i.e. 45 minutes will be pursued as with longer sessions children may tire out easily. Taping Technique for lip muscles would be used by cutting 2 "I" tapes according to the structure of lip muscles.The tape will be fixed in the center of the mouth on the upper lip, will be placed on an open mouth and a 10% tension will be given to the paper. The tape will then end at the corner of the upper lip. Kinesiotape wouldn't be placed on the lips. The second tape piece will be fixed to the center of the lower lip.The edges of the tape should overlap slightly. The other piece of tape will be placed under chin (base of tongue) on sub mandibular triangle, inside the jaw line on the base of the tongue. A strip 1-1 ½ inch long will be cut, and then will further be cut in half such that the stretch is horizontal. It will be anchored in the middle on sub mandibular triangle. Paper off the tension to both sides.

For the oral motor manipulation technique CP chair will be required to maintain the good sitting posture of children. Trunk will be in upright position with cut out lap board of the CP chair. Hips, knees and ankles would be flexed to 90 degrees. Shoulders and arms will be rested in symmetrical manner by keeping them rested in lap board and foot rest will be used to rest the feet tightly to control movement and maintain good posture. Each child would be taken for 12 weeks of therapy with three sessions per day of 15 minutes each. Oral motor manipulation like tapping protocols would be used for 45 minutes; slow, even rhythmic pressure will be applied around lip muscle and base of tongue muscle, keeping in view the comfort level of patient. Training to do manipulation exercises will be given to the parents of children with CP at .

Outcomes

Primary Outcome Measures

severity and frequency of drooling will be measured at baseline and at the end of 24 weeks of therapy
half of both groups will be intervene for 12 weeks first and other half groups after 12 weeks, so total 24 weeks will be required for whole group to be intervene

Secondary Outcome Measures

Full Information

First Posted
February 10, 2020
Last Updated
February 10, 2020
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT04266626
Brief Title
Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
Official Title
Clinical and Psychological Outcomes of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isra University

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
Children suffering from neurological problems may have a common problem of drooling and dysphagia.There is high prevelance of neurological disorders in developing countries including Pakistan.Parents of children with disability are highly stressed and burdenised while taking care of their children.there is a need to overcome the drooling and dysphagia problems with effective interventions.
Detailed Description
There is no clear consensus that which interventions are safe and effective and hard to decide about the effective intervention for drooling management. This will help the parents, therapist and children to manage their feeding problems effectively, hence improve quality of life of parents and children.There is also scarcity of well designed randomized controlled trails and limited published literature on the usefulness of the kinesiotape for management of drooling in children with oral dysphagia, this study will be conducted in an attempt to evaluate the same. There is also a lack of comparative studies to evaluate the effectiveness of traditional oral motor therapies and kinesiotaping therapy. speech pathologists and help them in managing drooling effectively by using the best effective therapeutic approach. This study will also add up evidence-based knowledge to existing literature

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drooling
Keywords
dysphagia, drooling, kinsesiotaping therapy, manipulation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A kinesiotaping therapy
Arm Type
Experimental
Arm Description
Protocols mentioned in kinesiological taping i.e. 45 minutes will be pursued as with longer sessions children may tire out easily. Taping Technique for lip muscles would be used by cutting 2 "I" tapes according to the structure of lip muscles.The tape will be fixed in the center of the mouth on the upper lip, will be placed on an open mouth and a 10% tension will be given to the paper. The tape will then end at the corner of the upper lip. Kinesiotape wouldn't be placed on the lips. The second tape piece will be fixed to the center of the lower lip.The edges of the tape should overlap slightly. The other piece of tape will be placed under chin (base of tongue) on sub mandibular triangle, inside the jaw line on the base of the tongue. A strip 1-1 ½ inch long will be cut, and then will further be cut in half such that the stretch is horizontal. It will be anchored in the middle on sub mandibular triangle. Paper off the tension to both sides.
Arm Title
Group B Oral Motor Manipulation therapy
Arm Type
Active Comparator
Arm Description
For the oral motor manipulation technique CP chair will be required to maintain the good sitting posture of children. Trunk will be in upright position with cut out lap board of the CP chair. Hips, knees and ankles would be flexed to 90 degrees. Shoulders and arms will be rested in symmetrical manner by keeping them rested in lap board and foot rest will be used to rest the feet tightly to control movement and maintain good posture. Each child would be taken for 12 weeks of therapy with three sessions per day of 15 minutes each. Oral motor manipulation like tapping protocols would be used for 45 minutes; slow, even rhythmic pressure will be applied around lip muscle and base of tongue muscle, keeping in view the comfort level of patient. Training to do manipulation exercises will be given to the parents of children with CP at .
Intervention Type
Other
Intervention Name(s)
kinesiotaping therapy
Intervention Description
Kinesiotaping is a new therapeutic technique that gives support to the lip and tongue base muscles without restricting range of motion or blood flow.
Intervention Type
Other
Intervention Name(s)
oral motor manipulation therapy
Intervention Description
Manipulation therapy include tapping and massage of oral motor muscles including orbicularis oris and base of tongue.
Primary Outcome Measure Information:
Title
severity and frequency of drooling will be measured at baseline and at the end of 24 weeks of therapy
Description
half of both groups will be intervene for 12 weeks first and other half groups after 12 weeks, so total 24 weeks will be required for whole group to be intervene
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Both male and female children with different non degenerative neurological disabilities ( cerebral palsy, traumatice brain injury, childhood stroke) and having oral phase dysphagia. Age between 3-15 years. Those who will have drooling severity rating of ≥ 4 on modified Teacher's drooling scale. Child who can comprehend simple verbal commands and on 3 words sentence level speech Have good head control. Parents and care givers of children with drooling and oral phase dysphagia will also be included in the study Exclusion Criteria: Those children who would have structural abnormality of respiratory system. Corrected or uncorrected cleft palate or cleft lip. Wounds around the lips. Recent surgery, and medication or on any treatment to control drooling would be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romana Pervez, PhD
Phone
03339867787
Email
romo_virgo@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ihsan Ullah, PhD
Phone
+923219801344
Email
ihsan@cuiatd.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romana Pervez, PhD
Organizational Affiliation
helping hand Institute of Rehabilitation Sciences Mansehra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Romana Pervez
City
Abbottabad
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22010
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romana Pervez
Phone
+923339867787
Email
romo_virgo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Abdul Haseeb Bhutta
Phone
+923479470947
Email
abdulhaseeb@hhirs.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Kinesiotaping and Manipulation Therapies in Drooling Management Among Children With Oral Dysphagia

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