NCT04966689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

July 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

June 30, 2021

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Voice Handicap Index (VHI)

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

  • maximum phonation time (MPT)

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

  • Speech Intelligibility

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

  • Swallowing Disturbance Questionnaire (SDQ)

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

  • Dysphagia handicap index (DHI)

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

  • +6 more secondary outcomes

Study Arms (3)

combined speech and music therapy

EXPERIMENTAL

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

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

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

Behavioral: music therapy

Interventions

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

combined speech and music therapy
speech therapyBEHAVIORAL

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

speech therapy
music therapyBEHAVIORAL

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

music therapy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iran University of Medical Sciences

Tehran, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Speech DisordersVoice DisordersParkinson Disease

Interventions

Music TherapySpeech Therapy

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesRehabilitation of Speech and Language Disorders

Study Officials

  • Reyhaneh Mohammadi

    Iran university of medical science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 19, 2021

Study Start

July 17, 2021

Primary Completion

January 7, 2022

Study Completion

January 30, 2022

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations