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

Sponsor
Ruijin Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04528147
Collaborator
(none)
20
1
2
35.9
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yi Jin Jing Tiger Roaring Speech Rehabilitation
  • Behavioral: Conventional Speech Rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yi Jin Jing Tiger Roaring Speech Rehabilitation

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
A traditional Chinese medicine treatment

Experimental: Conventional 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 active speech rehabilitation method recommended by the Parkinson's Foundation of America

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital Shanghai Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bomin Sun, Chief physician, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT04528147
Other Study ID Numbers:
  • TRS study
First Posted:
Aug 27, 2020
Last Update Posted:
Aug 27, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2020