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

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

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.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders; Lateral Medullary Syndrome
• Intervention / Treatment: Other: conventional dysphagia treatment; Other: motor imagery based on action observation treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • the First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; conventional dysphagia treatment and motor imagery based on action observation treatment	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.; Other: 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.
Active Comparator: The control group; conventional dysphagia treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
yale pharyngeal residue severity rating scale	Yale pharyngeal residue severity rating scale scores were measured using a 5-point ordinal scale: Ⅰ = none, Ⅱ = trace, Ⅲ = mild, Ⅳ = moderate, Ⅴ = severe.	day 1 and day 14
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
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

Collaborators and Investigators

• Sponsor: Le Wang
• Investigators: Study Director: Xi Zeng, the First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Ischemia; Esophageal Diseases; Infarction; Stroke; Brain Infarction; Brain Stem Infarctions; Syndrome; Deglutition Disorders; Lateral Medullary Syndrome
• Other Study ID Numbers: 2020-PT310-01 (Other Grant/Funding Number: Chinese academy of medical science)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No