Clinical trial NCT04528147: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Speech Disorders
Parkinson Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes:
measure: Differences in voice parameters between treatment conditions in the on- and off- medication states
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.
timeFrame: Baseline, 4 weeks
measure: Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions.
timeFrame: Baseline, 4 weeks
measure: Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions.
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
state: Shanghai
Study officials:
References: