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Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult

Primary Purpose

Developmental Stuttering

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Digital Manipulation of Thyroid cartilage
Fluency Shaping Therapy
combination Group
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Developmental Stuttering focused on measuring Fluency shaping therapy, Digital Manipulation, Stuttering, communication

Eligibility Criteria

18 Years - 30 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Developmental stuttering
  • Between age of 18 to 30 years
  • Only male

Exclusion Criteria:

  • Language disorders
  • Cluttering
  • Neurological stuttering

Sites / Locations

  • National Institute of Rehabilitation Medicine (NIRM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Digital Manipulation

fluency shaping Therapy

combination Group

Arm Description

Digital manipulation of thyroid cartilage (DMT) Duration: Each child was given 15-20 minute session. Frequency: Twice in a week. Total 24 sessions were performed. The aim of DMT was to reduce the severity of stuttering and improve the fluency.

Fluency Shaping Therapy Duration:Each child was given 30-minute session. Fluency Shaping Therapy (FST) Frequency: Twice in a week Total 24 sessions were performed. The aim of DMT was to reduce the severity of stuttering and improve the fluency

Combination Group (DMT+FST) Duration:Each subject was given 45-Minute session Frequency: Twice in a week Total 24 sessions were performed combination group was more significant option for reducing the severity of stuttering and improve fluency than practice the single DMT or FST

Outcomes

Primary Outcome Measures

Scale for Rating the severity of stuttering
0-No Stuttering Very mild-stuttering . Mild-stuttering. Mild to moderate-stuttering. Moderate -stuttering. Moderate to severe stuttering Severe-stuttering . 7 Very severe -stuttering .
Modified Erickson scale of communication attitude(24)
This 24-item scale distinguishes the extent to which a stuttering person's communication attitude deviates from normed attitudes. Statement require a true or false answer. Individual with mean score of 19.22 and range of 9-24 is consider as stutter. Individual with mean score of 9.4 and range of 1-21 is consider as non-stutter. The higher the score, the poorer the communication attitude.
Assessment of Physiological Factors Associated with Stuttering
Clinician need to carefully observe whether these physiological factor are present or not present during stuttering. 0=not present 1= present

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
July 24, 2019
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT03628755
Brief Title
Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
Official Title
Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
This study was conducted to determine the effectiveness of digital manipulation of thyroid cartilage for the management of stuttering in adult.There were three groups,Group A received Digital Manipulation of Thyroid cartilage (DMT),Group B received Fluency shaping Therapy(FST),Group C received combination of DMT,FST.
Detailed Description
The purpose of speech therapy is to stop progression of stuttering while teaching the method to client how to cope efficiently his or her stuttering disorder. The goal of fluency shaping therapy to eliminate the severity of stuttering by adopting the specific pattern of speech production and also reduce negative reaction to stuttering by default). Digital manipulation of thyroid cartilage decreases tension in vocal fold and reduces severity of stuttering and improves production of speech. DMT reduces unnecessary amount of tension in vocal tract and participant speaks with relax respiration,phonation, articulation and facilitate more fluent.in DMT subject speaks in natural way rather than in specific method in every situation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Stuttering
Keywords
Fluency shaping therapy, Digital Manipulation, Stuttering, communication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The three group were digital manipulation of thyroid cartilage(DMT) group,fluency shaping therapy (FST) group,combination of DMT,FST. the intervention period for each subject was three month and data was collected on day one and at the end of every 2 weeks. 4th week , 8th week, and 12th week which were aimed to reduce severity of stuttering and improve fluency
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Manipulation
Arm Type
Active Comparator
Arm Description
Digital manipulation of thyroid cartilage (DMT) Duration: Each child was given 15-20 minute session. Frequency: Twice in a week. Total 24 sessions were performed. The aim of DMT was to reduce the severity of stuttering and improve the fluency.
Arm Title
fluency shaping Therapy
Arm Type
Active Comparator
Arm Description
Fluency Shaping Therapy Duration:Each child was given 30-minute session. Fluency Shaping Therapy (FST) Frequency: Twice in a week Total 24 sessions were performed. The aim of DMT was to reduce the severity of stuttering and improve the fluency
Arm Title
combination Group
Arm Type
Experimental
Arm Description
Combination Group (DMT+FST) Duration:Each subject was given 45-Minute session Frequency: Twice in a week Total 24 sessions were performed combination group was more significant option for reducing the severity of stuttering and improve fluency than practice the single DMT or FST
Intervention Type
Behavioral
Intervention Name(s)
Digital Manipulation of Thyroid cartilage
Intervention Description
Digital manipulation of thyroid cartilage was applied to the anterior aspect of thyroid cartilage while using the thumb or finger and the patient was asked to speak. prolongation of vowel is 7 to 8 seconds, voice rest after each set is 10 second. total repetition is 60.
Intervention Type
Behavioral
Intervention Name(s)
Fluency Shaping Therapy
Intervention Description
FST session comprised of speech techniques such as prolongation of sounds, easy onset, continuous phonation, light articulatory contact, in reading and conversation in three speaking situations (speaking with therapist, reading aloud, and free conversation Reading task was for 80 short phrases.
Intervention Type
Behavioral
Intervention Name(s)
combination Group
Intervention Description
combination group intervention of DMT + FST
Primary Outcome Measure Information:
Title
Scale for Rating the severity of stuttering
Description
0-No Stuttering Very mild-stuttering . Mild-stuttering. Mild to moderate-stuttering. Moderate -stuttering. Moderate to severe stuttering Severe-stuttering . 7 Very severe -stuttering .
Time Frame
12 weeks
Title
Modified Erickson scale of communication attitude(24)
Description
This 24-item scale distinguishes the extent to which a stuttering person's communication attitude deviates from normed attitudes. Statement require a true or false answer. Individual with mean score of 19.22 and range of 9-24 is consider as stutter. Individual with mean score of 9.4 and range of 1-21 is consider as non-stutter. The higher the score, the poorer the communication attitude.
Time Frame
12week
Title
Assessment of Physiological Factors Associated with Stuttering
Description
Clinician need to carefully observe whether these physiological factor are present or not present during stuttering. 0=not present 1= present
Time Frame
12 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Developmental stuttering Between age of 18 to 30 years Only male Exclusion Criteria: Language disorders Cluttering Neurological stuttering
Facility Information:
Facility Name
National Institute of Rehabilitation Medicine (NIRM)
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

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Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult

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