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NCT Number: NCT06224686

The 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. standardized swallowing assessment

    Time frame: day 1 and day 14

    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.

  2. cortical activation during volitional swallowing

    Time frame: day 1 and day 14

    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.

  3. cortical activation during swallowing motor imagery

    Time frame: day 1

    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.

Secondary outcomes

  1. Murray secretion scale

    Time frame: day 1 and day 14

    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.

  2. yale pharyngeal residue severity rating scale

    Time frame: day 1 and day 14

    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.

  3. Rosenbek penetration-aspiration scale

    Time frame: day 1 and day 14

    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).

  4. swallowing-quality of life

    Time frame: day 1 and day 14

    Swallowing-quality of life has a score range of 44 - 220, with lower scores indicating poorer swallowing function and poorer quality of life.

Sponsors and collaborators

Lead sponsor

Le Wang

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2024
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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