Speech DisordersNCT04966689
The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)
A study testing combined speech and music therapy, speech therapy and music therapy in people with Speech Disorders and Voice Disorders, run by Iran University of Medical Sciences at 1 site in Iran.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Speech Disorders, Voice Disorders, Parkinson Disease
- What is being tested?
- combined speech and music therapy, speech therapy and music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIran
- Study dates
- 17 Jul 2021to 30 Jan 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson's disease (IPD)
- Patients who are in stages 1-3 according to Hoehn \& Yahr test
- Native language is persian
- The patient or family complains about the person's speech condition
- Adequate vision and hearing
- No history of stroke, head injury, brain surgery, laryngeal diseases such as vocal cord nodules
Show all 9Show fewer
- No other neurological disorders other than IPD
- Do not use treatment other than medication (such as deep brain stimulation surgery (DBS)
- informed consent
Who cannot join
- If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effect of Speech Therapy , Music-therapy and Combined Speech and Music Therapy on the Vocal Characteristics of People With PD by Using Telerehabilitation
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.
Read the detailed description
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.
- Conditions
- Speech Disorders, Voice Disorders, Parkinson Disease
- Being tested
- combined speech and music therapy, speech therapy, music therapy
- Medical subject headings
- Speech Disorders, Voice Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined speech and music therapyBehavioural
he telerehabilitation intervention that include both speech therapy and music therapy at the same time
speech therapyBehavioural
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 therapyBehavioural
music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| combined speech and music therapy | Experimental | the telerehabilitation intervention that include both speech therapy and music therapy at the same time Receives: Behavioral: combined speech and music therapy |
| speech therapy | Active comparator | 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 Receives: Behavioral: speech therapy |
| music therapy | Active comparator | music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation Receives: Behavioral: music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in loudness at 4 weeks and 3 month follow up
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from highest and lowest frequency at 4 weeks and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start17 Jul 2021
- Primary completion7 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Speech DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reyhaneh Mohammadi, Study director, Iran university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966689
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2023
- First submitted
- 30 Jun 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohseni Z, Mohamadi R, Habibi SAH, Saffarian A, Abolghasemi J. Voice improvement following conventional speech therapy combined with singing intervention in people with Parkinson's disease: A three-arm randomised controlled trial. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1752-1767. doi: 10.1111/1460-6984.12900. Epub 2023 Jun 7.
PubMed 37282797
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effect of Speech Therapy , Music-therapy and Combined Speech and Music Therapy on the Vocal Characteristics of People With PD by Using Telerehabilitation
- ClinicalTrials.gov ID
- NCT04966689
- Acronym / sponsor ID
- 1
- Conditions
- Speech Disorders, Voice Disorders, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 19 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined speech and music therapy | Experimental | Behavioral: combined speech and music therapythe telerehabilitation intervention that include both speech therapy and music therapy at the same time |
| speech therapy | Active comparator | Behavioral: speech therapyA 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 therapy | Active comparator | Behavioral: music therapymusic exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with idiopathic Parkinson's disease (IPD)
- Patients who are in stages 1-3 according to Hoehn \& Yahr test
- Native language is persian
- The patient or family complains about the person's speech condition
- Adequate vision and hearing
Key exclusion criteria (2 listed)
- If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment
- Lack of cooperation
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 |
|---|---|---|
| combined speech and music therapyhe telerehabilitation intervention that include both speech therapy and music therapy at the same time | Behavioural | combined speech and music therapy |
| speech therapyA 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 | Behavioural | speech therapy |
| music therapymusic exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation | Behavioural | music therapy |
Primary outcome
loudness
Time frame: Change from Baseline in loudness at 4 weeks and 3 month follow up
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.
11 secondary outcomes
Voice Handicap Index (VHI)
Time frame: Change from Baseline in VHI at 4 weeks and 3 month follow up
maximum phonation time (MPT)
Time frame: Change from Baseline in MPT at 4 weeks and 3 month follow up
Speech Intelligibility
Time frame: Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up
Swallowing Disturbance Questionnaire (SDQ)
Time frame: Change from Baseline in SDQ at 4 weeks and 3 month follow up
Dysphagia handicap index (DHI)
Time frame: Change from Baseline in DHI at 4 weeks and 3 month follow up
northwest dysphagia patient check sheet (NDPCS)
Time frame: Change from Baseline in NDPCS at 4 weeks and 3 month follow up
Geriatric Depressive Scale (GDS)
Time frame: Change from Baseline in GDS at 4 weeks and 3 month follow up
quality of life (QoL)
Time frame: Change from Baseline in QOL at 4 weeks and 3 month follow up
jitter
Time frame: Change from Baseline in jitter at 4 weeks and 3 month follow up
shimmer
Time frame: Change from Baseline in shimmer at 4 weeks and 3 month follow up
highest and lowest frequency
Time frame: Change from highest and lowest frequency at 4 weeks and 3 month follow up
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 4 Apr 2023.
- Derived from this study: PubMed 37282797Mohseni Z, Mohamadi R, Habibi SAH, Saffarian A, Abolghasemi J. Voice improvement following conventional speech therapy combined with singing intervention in people with Parkinson's disease: A three-arm randomised controlled trial. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1752-1767. doi: 10.1111/1460-6984.12900. Epub 2023 Jun 7.
- Individual participant dataSharing planned: No
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
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RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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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.
Reyhaneh Mohammadi study director
Iran university of medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined speech and music therapy, speech therapy and music therapy in people with Speech Disorders and Voice Disorders, run by Iran University of Medical Sciences at 1 site in Iran.
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 9 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: finished, as of the sponsor's last update on 4 Apr 2023. 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 Iran. 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?
loudness (time frame: Change from Baseline in loudness at 4 weeks and 3 month follow up). 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 NCT04966689, which also lists 1 linked publication.
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 4 Apr 2023.