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

NCT06224686 | Completed

• 1 other identifier: 2020-PT310-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Medullary Syndrome; Deglutition Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Murray secretion scale

  day 1 and day 14

• yale pharyngeal residue severity rating scale

  day 1 and day 14

• Rosenbek penetration-aspiration scale

  day 1 and day 14

• swallowing-quality of life

  day 1 and day 14

Study Arms (2)

The experimental group

EXPERIMENTAL

conventional dysphagia treatment and motor imagery based on action observation treatment

Other: conventional dysphagia treatment; Other: motor imagery based on action observation treatment

The control group

ACTIVE COMPARATOR

conventional dysphagia treatment

Other: conventional dysphagia treatment

Interventions

conventional dysphagia treatment OTHER

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.

The control group; The experimental group

motor imagery based on action observation treatment OTHER

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.

The experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Le Wang: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Lateral Medullary Syndrome; Deglutition Disorders

Condition Hierarchy (Ancestors)

Brain Stem Infarctions; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Xi Zeng

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 25, 2024
• Study Start: May 30, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 31, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)