ClinicalTrials.gg
Status unknownNCT04266626Updated Feb 12, 2020

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

An interventional study of kinesiotaping therapy and oral motor manipulation therapy in Drooling, sponsored by Isra University. Status unknown at 1 site in Pakistan. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by Isra University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
3 Years to 15 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Drooling

Keywords

  • dysphagia, drooling, kinsesiotaping therapy, manipulation therapy
03

In context

Sialorrhea

60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.

This study's planned enrollment of 60 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.

Browse Sialorrhea studies →

Lead sponsor

Isra University is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group A kinesiotaping therapy

    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

  • Active comparator
    Group B Oral Motor Manipulation therapy

    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

  • Otherkinesiotaping therapy

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

  • Otheroral motor manipulation therapy

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

06

What researchers measure

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

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2020 (actual). Primary completion is estimated for Jun 2020, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2020
First posted
Feb 12, 2020
StartActual
Jan 1, 2020
Primary completionEst.
Jun 2020
CompletionEst.
Sep 2020
Last update
Feb 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04266626
Lead sponsor
Isra University
Responsible party
Sponsor
First posted
Feb 12, 2020
Start date
Jan 1, 2020
Primary completion
Jun 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Feb 12, 2020

Study contacts

Romana Pervez, PhD
Contact
romo_virgo@hotmail.com
03339867787
Ihsan Ullah, PhD
Contact
ihsan@cuiatd.edu.pk
+923219801344
Romana Pervez, PhD
principal investigator · helping hand Institute of Rehabilitation Sciences Mansehra

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion