- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528147
Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD
August 22, 2020 updated by: Bomin Sun, Ruijin Hospital
Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for Treatment of Speech Disorders in Parkinson's Disease: A Perspective Cohort Study
Speech disorders affect more than 90% of patients with Parkinson's disease (PD).
Neither of conventional drugs nor surgery can effectively improve speech function.
Western speech rehabilitation is effective for speech disorders, but the domestic use of those methods used is limited.
Our preliminary results revealed that traditional Chinese Yi jin jing tiger roaring speech rehabilitation is effectively in the treatment of speech disorders in PD, however, high-quality clinical evidence is still scarce.
In order to solve this problem, we will conduct a prospective cohort study to explore the effects of Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique on speech disorders in PD patients.
This study will help to establish a set of Chinese Medicine treatment and objective evaluation methods for PD speech disorders.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dianyou Li, MD, PhD
- Phone Number: +8613817864569
- Email: ldy11483@rjh.com.cn
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200025
- Functional neurosurgery of Shanghai Jiaotong University affiliated Ruijin Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with idiopathic Parkinson's disease
- Native language is Chinese
- VHI-10 score more than 10
- informed consent
Exclusion Criteria:
- Previous or concurrent medical history affecting swallowing function (laryngeal diseases such as vocal nodules, gastroesophageal reflux, and laryngeal cancer).
- History of serious psychosis
- Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
- Dementia (A Mini-Mental State Examination (MMSE) score of < 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
- Lack of cooperation
- Additional reasons for exclusion at the discretion of the clinical investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yi Jin Jing Tiger Roaring Speech Rehabilitation
Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique Duration: Each time requires an hour of training; Frequency: three times a week, 4 weeks in total.
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A traditional Chinese medicine treatment
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Experimental: Conventional Speech Rehabilitation
Patients will receive speech rehabilitation recommended by The Parkinson's Foundation. Duration: Each time requires an hour of training; Frequency: three times a week, 4 weeks in total. |
A active speech rehabilitation method recommended by the Parkinson's Foundation of America
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction.
VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in voice parameters between treatment conditions in the on- and off- medication states
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
Voice recording at a sampling rate of 44.1 kHz using 16-bit quantification will be conducted in a sound-treated room using a microphone and a digital voice recorder with a mouth-to-microphone distance of 15 cm.
The recorded voices will then be used for a composit acoustic analysis.
|
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
Burg Balance Scale measures patients' static and dynamic balance abilities.
BBS score has a range of 0 (severe balance problems) to 56 (no balance problems).
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
The Water Swallow Test is frequently used in clinical practice as a functional assessment to detect dysphagia, with stage 1 indicating severe dysphagia and stage 6 indicating normal swallowing function.
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.
Time Frame: Baseline, 4 weeks
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Beck Depression Inventory is a self-administered Instrument, contains 21 self-report items.
The items are scored as 0, 1, 2, or 3.
The score range is 0 (no depression) to 63 (severe depression).
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Baseline, 4 weeks
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Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions.
Time Frame: Baseline, 4 weeks
|
The BAI is a rating scale used to evaluate the severity of anxiety symptoms.
It contains 21 self-report items.
The items are scored as 0, 1, 2, or 3.
The score range is 0-63.
A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
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Baseline, 4 weeks
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Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions.
Time Frame: Baseline, 4 weeks
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8-item Parkinson's Disease Questionnaire is a 8-item health-related quality of life instrument for subjects with Parkinson's Disease, which has a score range of 0 (good life quality) to 32 (very bad life quality).
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Baseline, 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
August 22, 2020
First Submitted That Met QC Criteria
August 22, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 22, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Language Disorders
- Communication Disorders
- Parkinson Disease
- Speech Disorders
Other Study ID Numbers
- TRS study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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