An interventional study of Yi Jin Jing Tiger Roaring Speech Rehabilitation and Conventional Speech Rehabilitation in Speech Disorders and Parkinson Disease, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 54 interventional studies indexed under Speech Disorders.
Browse Speech Disorders studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Yi Jin Jing Tiger Roaring 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.
Behavioral: Conventional Speech Rehabilitation
A traditional Chinese medicine treatment
A active speech rehabilitation method recommended by the Parkinson's Foundation of America
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).
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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.
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.
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 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).
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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.
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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).
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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).
Time frame: Baseline, 4 weeks
Plan to share: No
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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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