Efficacy of Passive Oral Motor Therapy on Drooling in Children With Multiple Disabilities

NCT02333981 | Completed

• 1 other identifier: D1234
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was formulated to determine the efficacy of passive oral motor regimen for drooling in children with multiple disabilities. Seven subjects aged 7-19yrs were taken in the study. All the subjects received passive treatment which included light touch, stroking, vibration, tapping, pressure and stretch. All the techniques have been proved to be effective in treating drooling. Relative sterility and hygiene was maintained throughout the procedure as sterilized gloves and napkins were used. The measurement protocol was designed to check effectiveness on drooling in children. The protocol was given for 4 weeks with treatment sessions given 3 times per week and the treatment duration was 30min. Twelve sessions of oral motor stimulation therapy given during the 4 weeks. Thirteen after 4 weeks of treatment, improvement was found in terms of the severity as well. Primary outcome measure taken was Drooling Frequency and Severity rating scale and secondary outcome measure being taken was drool quotient. Pre and post intervention scores of Drooling Frequency and Severity rating scale and drool quotient were taken and data was analyzed using wilcoxon signed rank test .

Conditions

Multiple Disabilities

Outcome Measures

Primary Outcomes (1)

• Drooling Frequency and Severity rating scale

  4 weeks

Secondary Outcomes (1)

• Drool Quotient method

  4 weeks

Study Arms (1)

Passive oral motor therapy group

EXPERIMENTAL

All the subjects received passive treatment which included light touch, stroking, vibration, tapping, pressure and stretch. All the techniques have been proved to be effective in treating drooling. Relative sterility and hygiene was maintained throughout the procedure as sterilized gloves and napkins were used. The measurement protocol was designed to check effectiveness on drooling in children. The protocol was given for 4 weeks with treatment sessions given 3 times per week and the treatment duration was 30min.12 sessions of oral motor stimulation therapy given during the 4 weeks..

Device: passive oral motor therapy for drooling

Interventions

passive oral motor therapy for drooling DEVICE

7 subjects aged 7-19 yrs were taken . All subjects received passive treatment which included light touch, stroking, vibration with (mechanical vibrator), tapping, pressure and stretch. All the techniques have been proved to be effective in treating drooling. Relative sterility and hygiene was maintained throughout the procedure as sterilized gloves and napkins were used. The measurement protocol was designed to check effectiveness on drooling in children. The protocol was given for 4 weeks with treatment sessions given 3 times per week and the treatment duration was 30min.12 sessions of oral motor stimulation therapy given during the 4 weeks..

Passive oral motor therapy group

Eligibility Criteria

• Age: 7 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 7-19 yrs (male and female)
• Confirmed diagnosis of multiple disability Score of ≤ 3 on drooling severity and frequency scale (indicating moderate to profuse drooling)
• Medication, taken to treat drooling, stopped at least 3 months before start of the study

You may not qualify if:

• No History of Previous surgical procedure for saliva control
• Use of drugs that interfere with saliva secretion (anticholinergic and neuroleptic drugs, benzodiazepines)
• Use of oral prosthetic devices
• Tactile hypersensitivity and oral problems like caries, toothache
• Congenital defects like cleft palate
• systemic diseases (bronchial asthma, congenital heart failure, and myasthenia gravis)
• Previous surgical procedures in the oral/nasal cavity interfering with saliva production
• Respiratory dysfunction

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Officials

• DIVYA MIDHA, MPT(NEURO)

  MAHARISHI MARKANDESHWAR UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 8, 2015
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: January 8, 2015

Record last verified: 2015-01