Developmental StutteringNCT03628755
Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
A study testing Digital Manipulation of Thyroid cartilage, Fluency Shaping Therapy and combination Group in people with Developmental Stuttering, run by Isra University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Developmental Stuttering
- What is being tested?
- Digital Manipulation of Thyroid cartilage, Fluency Shaping Therapy and combination Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2018to 18 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Developmental stuttering
- Between age of 18 to 30 years
- Only male
Who cannot join
- Language disorders
- Cluttering
- Neurological stuttering
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Rehabilitation Medicine (NIRM)
Islamabad, Federal, 44000
About this study
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.
Read the 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.
- Conditions
- Developmental Stuttering
- Being tested
- Digital Manipulation of Thyroid cartilage, Fluency Shaping Therapy, combination Group
- Keywords
- Fluency shaping therapy, Digital Manipulation, Stuttering, communication
- Medical subject headings
- Stuttering, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Manipulation of Thyroid cartilageBehavioural
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.
Fluency Shaping TherapyBehavioural
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 GroupBehavioural
combination group intervention of DMT + FST
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Behavioral: Digital Manipulation of Thyroid cartilage; Behavioral: Fluency Shaping Therapy; Behavioral: combination Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Jun 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental StutteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasir Khan, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628755
- Sponsor's protocol ID
- IIRS-IUISB/PHD/016
- Status last verified
- Jul 2019
- First submitted
- 9 Aug 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
- ClinicalTrials.gov ID
- NCT03628755
- Acronym / sponsor ID
- IIRS-IUISB/PHD/016
- Conditions
- Developmental Stuttering
- Keywords
- Fluency shaping therapy, Digital Manipulation, Stuttering, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Digital Manipulation | Active comparator | Behavioral: Digital Manipulation of Thyroid cartilageDigital 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 | Active comparator | Behavioral: Fluency Shaping TherapyFluency 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 | Experimental | Behavioral: Digital Manipulation of Thyroid cartilage, Behavioral: Fluency Shaping Therapy, Behavioral: combination GroupCombination 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Developmental stuttering
- Between age of 18 to 30 years
- Only male
Key exclusion criteria (3 listed)
- Language disorders
- Cluttering
- Neurological stuttering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Manipulation of Thyroid cartilageDigital 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. | Behavioural | Digital Manipulation, combination Group |
| Fluency Shaping TherapyFST 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. | Behavioural | combination Group, fluency shaping Therapy |
| combination Groupcombination group intervention of DMT + FST | Behavioural | combination Group |
Primary outcome
Scale for Rating the severity of stuttering
Time frame: 12 weeks
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 .
Modified Erickson scale of communication attitude(24)
Time frame: 12week
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
Time frame: 12 week
Clinician need to carefully observe whether these physiological factor are present or not present during stuttering. 0=not present 1= present
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Manipulation of Thyroid cartilage, Fluency Shaping Therapy and combination Group in people with Developmental Stuttering, run by Isra University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Rating the severity of stuttering (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.