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

NCT04266626 | Unknown

• 1 other identifier: 1602-PhD-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Drooling

Keywords

dysphagia, drooling, kinsesiotaping therapy, manipulation therapy

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Study Arms (2)

Group A kinesiotaping therapy

EXPERIMENTAL

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.

Other: kinesiotaping therapy

Group B Oral Motor Manipulation therapy

ACTIVE COMPARATOR

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 .

Other: oral motor manipulation therapy

Interventions

kinesiotaping therapy OTHER

Kinesiotaping is a new therapeutic technique that gives support to the lip and tongue base muscles without restricting range of motion or blood flow.

Group A kinesiotaping therapy

oral motor manipulation therapy OTHER

Manipulation therapy include tapping and massage of oral motor muscles including orbicularis oris and base of tongue.

Group B Oral Motor Manipulation therapy

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Romana Pervez

Abbottabad, Khyber Pakhtunkhwa, 22010, Pakistan

RECRUITING

MeSH Terms

Conditions

Sialorrhea; Deglutition Disorders

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Romana Pervez, PhD

  helping hand Institute of Rehabilitation Sciences Mansehra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romana Pervez, PhD

CONTACT

03339867787; romo_virgo@hotmail.com

Ihsan Ullah, PhD

CONTACT

+923219801344; ihsan@cuiatd.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)