The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966689
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2023
• Source: Iran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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; 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 30, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Parkinson Disease
• Speech Disorders
• Voice Disorders

Intervention

Behavioral:
• combined speech and music therapy
he telerehabilitation intervention that include both speech therapy and music therapy at the same time
• speech 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
• music therapy
music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline in loudness at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in VHI at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in MPT at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in SDQ at 4 weeks and 3 month follow up
Secondary	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	Change from Baseline in DHI at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in NDPCS at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in GDS at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in QOL at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in jitter at 4 weeks and 3 month follow up
Secondary	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.	Change from Baseline in shimmer at 4 weeks and 3 month follow up
Secondary	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.	Change from highest and lowest frequency at 4 weeks and 3 month follow up