An interventional study of combined speech and music therapy and speech therapy in Speech Disorders, Voice Disorders and Parkinson Disease, sponsored by Iran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Iran University of Medical Sciences · Not applicable, Interventional, and Treatment
Speech and voice disorders are observed in almost 90% of patients with PD during their course of illness. Reduced voice pitch inflections or monotone speech, reduced vocal loudness, prosody disorders, the imprecise articulation of the consonants, hoarseness, and breathy voice is also observed in patients with PD; these symptoms often lead to reduced speech intelligibility. The aim of this study will to investigate the possible changes in the voice and speech features in people with PD after a combined speech and music therapy using Telerehabilitation.
the investigators of this study propose to conduct a pilot randomized, controlled trial in patients with PD to assess the potential effectiveness of a Telerehabilitation intervention that encourage a higher level of speech performance. The investigators hypothesize that patients in the combined treatment group will have more and better improve in the study outcome measures after treatment and 3 month follow up, as compared with patients in speech therapy group and music therapy group.
77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.
This study's enrollment of 33 is below the median of 38 across 54 interventional studies indexed under Speech Disorders.
Browse Speech Disorders studies →Iran University of Medical Sciences is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the telerehabilitation intervention that include both speech therapy and music therapy at the same time
Behavioral: combined speech and music therapy
A behavioural speech therapy program including breathing exercises, loudness, pitch, and intelligibility which are adapted from Lee Silverman Voice Treatment (LSVT) and voice exercises Which is delivered through telerehabilitation
Behavioral: speech therapy
music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation
Behavioral: music therapy
he telerehabilitation intervention that include both speech therapy and music therapy at the same time
A behavioural speech therapy program including breathing exercises, loudness, pitch, and intelligibility which are adapted from Lee Silverman Voice Treatment (LSVT) and voice exercises Which is delivered through telerehabilitation
music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation
loudness
Change in loudness over the period of the study which will be based on analysis of acoustic recordings. Loudness of voice will be measured in produce the vowel /a /, reading and spontaneous speech. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.
Time frame: Change from Baseline in loudness at 4 weeks and 3 month follow up
Voice Handicap Index (VHI)
Change in Persian version of Voice Handicap Index (VHI) over the period of the study. The VHI measures the influence of voice problems on a patient's quality of life. The VHI is a 30 item scale. The total scores range is 0-120. A score 60-120 indicates severe voice problem.
Time frame: Change from Baseline in VHI at 4 weeks and 3 month follow up
maximum phonation time (MPT)
Change in maximum phonation time (MPT) over the period of the study. MPT will be measured by asking the subject to produce the long vowel /a/. This vocalization is measured three times, and the longest MPT is recorded.
Time frame: Change from Baseline in MPT at 4 weeks and 3 month follow up
Speech Intelligibility
Change in fudalla speech intelligibility rating scale over the period of the study. This scale consists of 7 rates in which the number 1 indicates Speech is not intelligible and number 7 indicates Speech is totally intelligible.
Time frame: Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up
Swallowing Disturbance Questionnaire (SDQ)
Change in Persian version of Swallowing Disturbance Questionnaire (SDQ) over the period of the study. The SDQ is a 15 item scale. The total scores range is 0-45. A score higher 11 indicates swallowing difficulty.
Time frame: Change from Baseline in SDQ at 4 weeks and 3 month follow up
Dysphagia handicap index (DHI)
Change in Persian version of Dysphagia handicap index (DHI) over the period of the study. The DHI is one of the instruments used for measuring a dysphagic patient's self-assessment. it reflects the patient's quality of life. DHI is a 25 item scale. The total scores range is 0-100. A higher score indicates a greater impact of swallowing disorders on quality of life
Time frame: Change from Baseline in DHI at 4 weeks and 3 month follow up
northwest dysphagia patient check sheet (NDPCS)
Change in Persian version of northwest dysphagia patient check sheet (NPCS) scores over the period of the study. The NDPCS has five and 28 items. Each item is scored as safe or unsafe. The total score is calculated from the total number of unsafe items. The more unsafe observations indicates swallowing difficulty.
Time frame: Change from Baseline in NDPCS at 4 weeks and 3 month follow up
Geriatric Depressive Scale (GDS)
Change in Persian version of Geriatric Depressive Scale (GDS) scores over the period of the study. GDS is a 15 item scale. Each item is scored as yes or no. More than 5 signs indicate the possibility of depression and more than 10 signs of depression indicate definite depression.
Time frame: Change from Baseline in GDS at 4 weeks and 3 month follow up
quality of life (QoL)
Change in SF-36 questionnaire over the period of the study. Quality of life will be measured using SF-36 questionnaire. SF-36 is a 36 item scale. The total scores range is 0-100. A higher score indicates a better quality of life.
Time frame: Change from Baseline in QOL at 4 weeks and 3 month follow up
jitter
Change in jitter over the period of the study, which will be based on analysis of acoustic recordings. jitter will be measured in produce the vowel /a/. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.
Time frame: Change from Baseline in jitter at 4 weeks and 3 month follow up
shimmer
Change in shimmer over the period of the study, which will be based on analysis of acoustic recordings. shimmer will be measured in produce the vowel /a/. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.
Time frame: Change from Baseline in shimmer at 4 weeks and 3 month follow up
highest and lowest frequency
Change in highest and lowest frequency over the period of the study, which will be based on analysis of acoustic recordings. highest and lowest frequency will be measured by asking the subject to produce the vowel /a/ as high and low frequency as they can produces. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals.
Time frame: Change from highest and lowest frequency at 4 weeks and 3 month follow up
Plan to share: No
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Ran from Jul 2021 to primary completion in Jan 2022, 5 months.
Of 35 non-industry interventional studies with no phase under Speech Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 38. This study's 5 months is below that.
Counting every sponsor, half of 37 studies reached it within 28 months; a quarter within 17 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Iran University of Medical Sciences