The Motor Imagery Based on Action Observation Treatment on Dysphagia in Wallenberg Syndrome

Deglutition Disorders Clinical Trial

Official title:

The Effect and Mechanism of Motor Imagery Based on Action Observation Treatment on Dysphagia in Wallenberg Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06224686
• Other study ID #: 2020-PT310-01
• Status: Completed
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

• the efficacy of motor imagery based on action observation treatment in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

• apply functional near infrared spectroscopy to explore the mechanism of action of this therapy.

Participants received conventional dysphagia treatment and motor imagery based on action observation treatment once a day for 14 days. Researchers compared the control group to see the effect and mechanism of motor imagery based on action observation treatment.

Description:

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

• the efficacy of motor imagery based on action observation treatment in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

• apply functional near infrared spectroscopy to explore the mechanism of action of this therapy.

Both groups received conventional dysphagia treatment, and the experimental group underwent the addition of motor imagery based on action observation treatment to the control group once a day for 14 days. Overall swallowing function was assessed before treatment and after 14 days of intervention. Meanwhile, the functional near infrared spectroscopy was used to detect changes in cerebral hemodynamics during the execution of volitional swallowing task and swallowing motor imagery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age ranged from 18-80 years and right-handed;

• first onset, vital signs stable and conscious;

• the dysphagia confirmed by videofluoroscopic swallowing study;

• no cognitive impairment, the mini-mental state examination score: >17 for those with an illiterate education, >20 for those with an elementary education, and >24 for those with a secondary education and above;

• good motor imagery ability with kinesthetic and visual imagery questionnaire-10 score =25;

• cranial integrity without craniotomy and/or craniectomy;

• patient and/or his/her relative agrees and signs written informed consent.

Exclusion Criteria:

• combined ischemic foci at other sites;

• presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others;

• severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure;

• significant psychological disorders such as anxiety and depression;

• infected or broken skin on the head;

• poorly controlled epilepsy;

• poor patient compliance.

Related Conditions & MeSH terms

• Deglutition Disorders
• Syndrome

Intervention

Other:
• conventional dysphagia treatment
Conventional dysphagia treatment included oropharyngeal muscle movement training, orofacial alternating hot and cold stimulation, Masako swallowing training, Mendelsohn maneuver, therapeutic ingestion training, intermittent oral-esophageal tube feeding, and low-frequency electrical stimulation of swallowing neuromusculature, etc., 30 min each time, once a day for 14 consecutive days.
• motor imagery based on action observation treatment
First, the therapist explained the purpose and principle of the intervention method to the patient, keeping the surrounding environment quiet and comfortable to avoid the patient's mood fluctuations due to external interference. Then start the treatment, the video recorded in advance was given to the patient to watch, the playback device is a ipad. The content includes lip and tongue muscle relaxation exercises, healthy people eating, chewing, swallowing, drinking and other images. At the same time, the guidance was played, which was consistent with the content in the video. The video was played 3 times consecutively for 30 min each time, once a day for 14 days.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Le Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standardized swallowing assessment	The standardized swallowing assessment was used to assess the improvement of overall swallowing function, it has a maximum score of 46 and a minimum score of 18, with lower scores indicating better swallowing function.	day 1 and day 14
Primary	cortical activation during volitional swallowing	The functional near infrared spectroscopy system (Nirsmart, Danyang Huichuang Medical Equipment Co., Ltd., China) was used to detect changes in cerebralhemodynamics during the execution of volitional swallowing task.	day 1 and day 14
Primary	cortical activation during swallowing motor imagery	The functional near infrared spectroscopy system (Nirsmart, Danyang Huichuang Medical Equipment Co., Ltd., China) was used to detect changes in cerebralhemodynamics during the whole swallowing motor imagery.	day 1
Secondary	Murray secretion scale	The severity of Murray secretion scale was measured using a grade of 0-3, patients without obvious saliva accumulation are scored as MSS grade 0, whereas patients who had secretions in the laryngeal vestibule at the start of the exam were assigned grade 3.	day 1 and day 14
Secondary	yale pharyngeal residue severity rating scale	Yale pharyngeal residue severity rating scale scores were measured using a 5-point ordinal scale: ? = none, ? = trace, ? = mild, ? = moderate, ? = severe.	day 1 and day 14
Secondary	Rosenbek penetration-aspiration scale	The highest PAS score is 8 and the lowest is 1 (1 = no entry of material into the airway; 2 - 5 = penetration of material past the laryngeal additus into the supraglottic space and traveling as far as the true vocal folds; 6 - 8 = tracheal aspiration of material below the true vocal folds).	day 1 and day 14
Secondary	swallowing-quality of life	Swallowing-quality of life has a score range of 44 - 220, with lower scores indicating poorer swallowing function and poorer quality of life.	day 1 and day 14