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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04528147
• Other study ID #: TRS study
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2020
• Source: Ruijin Hospital
• Contact: Dianyou Li, MD, PhD
• Phone: +8613817864569
• Email: ldy11483[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Speech Disorders

Intervention

Behavioral:
• Yi Jin Jing Tiger Roaring Speech Rehabilitation
A traditional Chinese medicine treatment
• Conventional Speech Rehabilitation
A active speech rehabilitation method recommended by the Parkinson's Foundation of America

Locations

Country	Name	City	State
China	Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	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.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	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.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	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).	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	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.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	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).	Baseline, 4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	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).	Baseline, 4 weeks