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NCT Number: NCT04966689

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

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.

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Key information

Conditions

Speech Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Communication Disorders Language Disorders Laryngeal Diseases Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Synucleinopathies Voice Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iran University of Medical Sciences

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined speech and music therapy

Behavioral

he telerehabilitation intervention that include both speech therapy and music therapy at the same time

Speech Therapy

Behavioral

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

Behavioral

music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Voice Handicap Index (VHI)

    Time frame: Change from Baseline in VHI at 4 weeks and 3 month follow up

    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.

  2. maximum phonation time (MPT)

    Time frame: Change from Baseline in MPT at 4 weeks and 3 month follow up

    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.

  3. Speech Intelligibility

    Time frame: Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up

    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.

  4. Swallowing Disturbance Questionnaire (SDQ)

    Time frame: Change from Baseline in SDQ at 4 weeks and 3 month follow up

    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.

  5. Dysphagia handicap index (DHI)

    Time frame: Change from Baseline in DHI at 4 weeks and 3 month follow up

    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

  6. northwest dysphagia patient check sheet (NDPCS)

    Time frame: Change from Baseline in NDPCS at 4 weeks and 3 month follow up

    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.

  7. Geriatric Depressive Scale (GDS)

    Time frame: Change from Baseline in GDS at 4 weeks and 3 month follow up

    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.

  8. quality of life (QoL)

    Time frame: Change from Baseline in QOL at 4 weeks and 3 month follow up

    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.

  9. jitter

    Time frame: Change from Baseline in jitter at 4 weeks and 3 month follow up

    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.

  10. shimmer

    Time frame: Change from Baseline in shimmer at 4 weeks and 3 month follow up

    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.

  11. highest and lowest frequency

    Time frame: Change from highest and lowest frequency at 4 weeks and 3 month follow up

    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.

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2021
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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