Parkinson Disease, Speech Disorders
Conditions
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.
Interventions
BEHAVIORALYi Jin Jing Tiger Roaring Speech Rehabilitation
A traditional Chinese medicine treatment
BEHAVIORALConventional Speech Rehabilitation
A active speech rehabilitation method recommended by the Parkinson's Foundation of America
Sponsors
Ruijin Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. | 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). |
| Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states. | 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. |
| Differences in voice parameters between treatment conditions in the on- and off- medication states | 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. |
| Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions. | 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. |
| Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions. | Baseline, 4 weeks | 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). |
| Differences in Beck Depression Inventory (BDI) scores between Treatment conditions. | Baseline, 4 weeks | 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). |
Countries
China
Contacts
Primary ContactDianyou Li, MD, PhD
Outcome results
None listed