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Clinical Trials/CTRI/2024/01/061456
CTRI/2024/01/061456Not ApplicablePhase 2

Effectiveness of thermal stimulation to reduce drooling among children with cerebral palsy

Dipa Akter1 site in 1 country15 target enrollmentStarted: January 25, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not Applicable
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
Severity, Frequency, Impact of drooling
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

It is a quasi-experimental study with purposive sampling will conduct at Speech & Language Therapy Department of CRP, Savar, Dhaka, Bangladesh over a period of 8 therapy session. N=15, Cerebral Palsy cases with drooling , both gender, aged 3-12 years underwent thermal stimulation for drooling control. Severity and frequency of drooling will assess on Drooling Severity & Frequency Scale and Drooling Impact Scale before intervention and post intervention at 2 occasions. Statistical analysis will be carried using SPSS Version 25.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
3.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Presence of drooling Children whose parents are thought to be capable of adhering to the study protocol.

Exclusion Criteria

  • •Children using drugs or medication, other therapy that could control their saliva production or otherwise have an impact on their drooling.

Outcomes

Primary Outcomes

Severity, Frequency, Impact of drooling

Time Frame: 1 month treatment session

Secondary Outcomes

  • To evaluate the severity and frequency of drooling(240 hr)

Investigators

Sponsor
Dipa Akter
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DIPA AKTER

Bangladesh Health Professions Institute (BHPI), Savar, Dhaka

Study Sites (1)

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