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Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD

Primary Purpose

Speech Disorders, Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yi Jin Jing Tiger Roaring Speech Rehabilitation
Conventional Speech Rehabilitation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Disorders

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yi Jin Jing Tiger Roaring Speech Rehabilitation

Conventional Speech Rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
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).

Secondary Outcome Measures

Differences in voice parameters between treatment conditions in the on- and off- medication states
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.
Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
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).
Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
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.
Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.
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).
Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions.
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.
Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions.
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).

Full Information

First Posted
August 22, 2020
Last Updated
August 22, 2020
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04528147
Brief Title
Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Disorders, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yi Jin Jing Tiger Roaring Speech Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Speech Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yi Jin Jing Tiger Roaring Speech Rehabilitation
Intervention Description
A traditional Chinese medicine treatment
Intervention Type
Behavioral
Intervention Name(s)
Conventional Speech Rehabilitation
Intervention Description
A active speech rehabilitation method recommended by the Parkinson's Foundation of America
Primary Outcome Measure Information:
Title
Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
Description
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).
Time Frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Differences in voice parameters between treatment conditions in the on- and off- medication states
Description
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.
Time Frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Title
Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
Description
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
Title
Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
Description
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).
Time Frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Title
Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
Description
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.
Time Frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Title
Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.
Description
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).
Time Frame
Baseline, 4 weeks
Title
Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions.
Description
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.
Time Frame
Baseline, 4 weeks
Title
Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions.
Description
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).
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianyou Li, MD, PhD
Phone
+8613817864569
Email
ldy11483@rjh.com.cn
Facility Information:
Facility Name
Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD

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