StammeringNCT04813588
Comparison of Pantomiming and Easy Onset Treatment
A study testing Pantomiming and Easy onset in people with Stammering, run by Riphah International University at 1 site in Pakistan.
Trial summary
This research will give in-depth understanding of pantomiming and easy onset method as an intervention of stuttering and especially blocking. And by comparing both methods, It will also determine that which method is more effective. This research will also improve the overall awareness regarding stuttering Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Stammering
- What is being tested?
- Pantomiming and Easy onset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 1 Jun 2021
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants falling in this category would be added into the study.
- School aged children and adolescents ages between 6 to 18 years(both genders) who stutter with blocking symptoms
- Participant who will be at moderate level of stammering will be included
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Participants with any other medical condition will be excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Maryam Nadir Kiyani
Rawalpindi, Punjab Province, 43600
Maryam Kiyani, MsSLP, maryam.Kiyani@riphah.edu.pk
Saba Imtiaz, MS/SLP
About this study
Official title: Comparison of Pantomiming and Easy Onset Treatment on Blocking in Stammering
This research will give in-depth understanding of pantomiming and easy onset method as an intervention of stuttering and especially blocking. And by comparing both methods, It will also determine that which method is more effective. This research will also improve the overall awareness regarding stuttering
Read the detailed description
Research participants will be divided into two groups through randomization, Group A \& Group B. Base line assessment will be conducted. Intervention will be provided (thrice a week on alternative days).post assessment will be taken and data will be analyzed through SPSS.
- Conditions
- Stammering
- Being tested
- Pantomiming, Easy onset
- Keywords
- Pantomiming, Easy onset method, Blocking
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantomimingOther
Pantomiming with fluency shaping techniques
Easy onsetOther
Easy onset method with breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Pantomimng | Experimental | In experimental group pantomiming treatment will be administered Receives: Other: Pantomiming |
| Easy onset | Active comparator | In active comparator group easy onset method will be administered Receives: Other: Easy onset |
What is being measured
The primary outcome is the main question the study is designed to answer.
The real time analysis
Changes from base line "The Real time analysis will use. It will use to assessed the changes in frequency ,duration types and severity of disfluencies in spontaneous speech.The total number of dysfluencies will be divided by the total number of syllables then multiply answer by 100 .Results between 2% showed normal range,8-15% will consider Moderate level, 12% will consider as severe level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Mar 2021
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StammeringStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Kiyani, MS/SLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813588
- Sponsor's protocol ID
- REC/00897 Saba Imtiaz
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belyk M, Kraft SJ, Brown S. Stuttering as a trait or state - an ALE meta-analysis of neuroimaging studies. Eur J Neurosci. 2015 Jan;41(2):275-84. doi: 10.1111/ejn.12765. Epub 2014 Oct 28.
PubMed 253508672. Mundada M, Gawali B, Kayte S. Recognition and classification of speech and its related fluency disorders. International Journal of Computer Science and Information Technologies (IJCSIT). 2014;5(5):6764-7.
3. Hudock D, Altieri N, Sun L, Bowers A, Keil C, Kalinowski J. The effect of single syllable silent reading and pantomime speech in varied syllable positions on stuttering frequency throughout utterance productions. Speech Communication. 2015 Dec 1;75:76-83.
4. Waghmare SD, Deshmukh RR, Shrishrimal PP, Waghmare VB, Janvale GB, Sonawane B. A Comparative Study of Recognition Technique Used for Development of Automatic Stuttered Speech Dysfluency Recognition System. Indian Journal of Science and Technology. 2017 Jul;10(21):1-4.
Euler HA, Lange BP, Schroeder S, Neumann K. The effectiveness of stuttering treatments in Germany. J Fluency Disord. 2014 Mar;39:1-11. doi: 10.1016/j.jfludis.2014.01.002. Epub 2014 Jan 27.
PubMed 247591896. Kordell J. Outcomes of a Combined Mindfulness, Stuttering Modification, and Fluency Shaping Intervention for Children Who Stutter
7. Keil CM, Hudock D, Altieri N, Seikel AT. The Effects of Pantomine Speech & Silent Reading in Varied Syllable Positions Throughout a Phrase on Stuttering
8. Rifaie NA, Saber AS, El-Din ST, Sallam YA, Algamal AM. Efficacy of the Arabic Modified Fluency Shaping Program in the treatment of stuttering. The Egyptian Journal of Otolaryngology. 2016 Oct 1;32(4):306.
9. Franklin CM. The Effect of Easy Onset Time Treatment on Voice Onset Time in Stuttering.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pantomiming and Easy Onset Treatment on Blocking in Stammering
- ClinicalTrials.gov ID
- NCT04813588
- Acronym / sponsor ID
- REC/00897 Saba Imtiaz
- Conditions
- Stammering
- Keywords
- Pantomiming, Easy onset method, Blocking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 24 Mar 2021 (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 research will give in-depth understanding of pantomiming and easy onset method as an intervention of stuttering and especially blocking. And by comparing both methods, It will also determine that which method is more effective. This research will also improve the overall awareness regarding stuttering
Detailed description
Research participants will be divided into two groups through randomization, Group A \& Group B. Base line assessment will be conducted. Intervention will be provided (thrice a week on alternative days).post assessment will be taken and data will be analyzed through SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Pantomimng | Experimental | Other: PantomimingIn experimental group pantomiming treatment will be administered |
| Easy onset | Active comparator | Other: Easy onsetIn active comparator group easy onset method will be administered |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participants falling in this category would be added into the study.
- School aged children and adolescents ages between 6 to 18 years(both genders) who stutter with blocking symptoms
- Participant who will be at moderate level of stammering will be included
Key exclusion criteria (2 listed)
- Participant failing to fall in this category would be excluded of the study.
- Participants with any other medical condition will be excluded
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 |
|---|---|---|
| PantomimingPantomiming with fluency shaping techniques | Other | Pantomimng |
| Easy onsetEasy onset method with breathing exercises | Other | Easy onset |
Primary outcome
The real time analysis
Time frame: 12 weeks
Changes from base line "The Real time analysis will use. It will use to assessed the changes in frequency ,duration types and severity of disfluencies in spontaneous speech.The total number of dysfluencies will be divided by the total number of syllables then multiply answer by 100 .Results between 2% showed normal range,8-15% will consider Moderate level, 12% will consider as severe level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 25350867Belyk M, Kraft SJ, Brown S. Stuttering as a trait or state - an ALE meta-analysis of neuroimaging studies. Eur J Neurosci. 2015 Jan;41(2):275-84. doi: 10.1111/ejn.12765. Epub 2014 Oct 28.
- Background2. Mundada M, Gawali B, Kayte S. Recognition and classification of speech and its related fluency disorders. International Journal of Computer Science and Information Technologies (IJCSIT). 2014;5(5):6764-7.
- Background3. Hudock D, Altieri N, Sun L, Bowers A, Keil C, Kalinowski J. The effect of single syllable silent reading and pantomime speech in varied syllable positions on stuttering frequency throughout utterance productions. Speech Communication. 2015 Dec 1;75:76-83.
- Background4. Waghmare SD, Deshmukh RR, Shrishrimal PP, Waghmare VB, Janvale GB, Sonawane B. A Comparative Study of Recognition Technique Used for Development of Automatic Stuttered Speech Dysfluency Recognition System. Indian Journal of Science and Technology. 2017 Jul;10(21):1-4.
- Background: PubMed 24759189Euler HA, Lange BP, Schroeder S, Neumann K. The effectiveness of stuttering treatments in Germany. J Fluency Disord. 2014 Mar;39:1-11. doi: 10.1016/j.jfludis.2014.01.002. Epub 2014 Jan 27.
- Background6. Kordell J. Outcomes of a Combined Mindfulness, Stuttering Modification, and Fluency Shaping Intervention for Children Who Stutter
- Background7. Keil CM, Hudock D, Altieri N, Seikel AT. The Effects of Pantomine Speech & Silent Reading in Varied Syllable Positions Throughout a Phrase on Stuttering
- Background8. Rifaie NA, Saber AS, El-Din ST, Sallam YA, Algamal AM. Efficacy of the Arabic Modified Fluency Shaping Program in the treatment of stuttering. The Egyptian Journal of Otolaryngology. 2016 Oct 1;32(4):306.
- Background9. Franklin CM. The Effect of Easy Onset Time Treatment on Voice Onset Time in Stuttering.
- Individual participant dataSharing planned: No
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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.
Maryam Kiyani, MS/SLP principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantomiming and Easy onset in people with Stammering, run by Riphah International 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 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The real time analysis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813588, which also lists 9 linked publications.
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 24 Mar 2021.