NCT03628755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

August 9, 2018

Last Update Submit

July 24, 2019

Conditions

Keywords

Fluency shaping therapyDigital ManipulationStutteringcommunication

Outcome Measures

Primary Outcomes (3)

  • Scale for Rating the severity of stuttering

    0-No Stuttering 1. Very mild-stuttering . 2. Mild-stuttering. 3. Mild to moderate-stuttering. 4. Moderate -stuttering. 5. Moderate to severe stuttering 6. Severe-stuttering . 7 Very severe -stuttering .

    12 weeks

  • 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.

    12week

  • 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

    12 week

Study Arms (3)

Digital Manipulation

ACTIVE COMPARATOR

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.

Behavioral: Digital Manipulation of Thyroid cartilage

fluency shaping Therapy

ACTIVE COMPARATOR

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

Behavioral: Fluency Shaping Therapy

combination Group

EXPERIMENTAL

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

Behavioral: Digital Manipulation of Thyroid cartilageBehavioral: Fluency Shaping TherapyBehavioral: combination Group

Interventions

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.

Digital Manipulationcombination Group

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.

combination Groupfluency shaping Therapy

combination group intervention of DMT + FST

combination Group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Language disorders
  • Cluttering
  • Neurological stuttering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Rehabilitation Medicine (NIRM)

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

StutteringCommunication

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

September 1, 2018

Primary Completion

June 30, 2019

Study Completion

July 18, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations