Clinical trial NCT04966689: The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech Disorders
Voice Disorders
Parkinson Disease
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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; 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.

Eligibility criteria: Inclusion Criteria:

* 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
* No other neurological disorders other than IPD
* Do not use treatment other than medication (such as deep brain stimulation surgery (DBS)
* informed consent

Exclusion Criteria:

* If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment
* Lack of cooperation

Primary outcomes:
measure: loudness
timeFrame: Change from Baseline in loudness at 4 weeks and 3 month follow up
Secondary outcomes:
measure: Voice Handicap Index (VHI)
timeFrame: Change from Baseline in VHI at 4 weeks and 3 month follow up
measure: maximum phonation time (MPT)
timeFrame: Change from Baseline in MPT at 4 weeks and 3 month follow up
measure: Speech Intelligibility
timeFrame: Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up
measure: Swallowing Disturbance Questionnaire (SDQ)
timeFrame: Change from Baseline in SDQ at 4 weeks and 3 month follow up
measure: Dysphagia handicap index (DHI)
timeFrame: Change from Baseline in DHI at 4 weeks and 3 month follow up
measure: northwest dysphagia patient check sheet (NDPCS)
timeFrame: Change from Baseline in NDPCS at 4 weeks and 3 month follow up
measure: Geriatric Depressive Scale (GDS)
timeFrame: Change from Baseline in GDS at 4 weeks and 3 month follow up
measure: quality of life (QoL)
timeFrame: Change from Baseline in QOL at 4 weeks and 3 month follow up
measure: jitter
timeFrame: Change from Baseline in jitter at 4 weeks and 3 month follow up
measure: shimmer
timeFrame: Change from Baseline in shimmer at 4 weeks and 3 month follow up
measure: highest and lowest frequency
timeFrame: Change from highest and lowest frequency at 4 weeks and 3 month follow up
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iran University of Medical Sciences
Study officials:
affiliation: Iran university of medical science
name: Reyhaneh Mohammadi
role: STUDY_DIRECTOR
References: