Lateral Medullary SyndromeNCT06224686

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

A study testing conventional dysphagia treatment and motor imagery based on action observation treatment in people with Lateral Medullary Syndrome and Deglutition Disorders, run by Le Wang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lateral Medullary Syndrome, Deglutition Disorders
What is being tested?: conventional dysphagia treatment and motor imagery based on action observation treatment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 30 May 2023to 31 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Lateral Medullary Syndrome, Deglutition Disorders
Being tested: conventional dysphagia treatment, motor imagery based on action observation treatment
Medical subject headings: Lateral Medullary Syndrome, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

conventional dysphagia treatmentOther
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 treatmentOther
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.

Study groups in NCT06224686
Study group	Role	What they receive
The experimental group	Experimental	conventional dysphagia treatment and motor imagery based on action observation treatment Receives: Other: conventional dysphagia treatment; Other: motor imagery based on action observation treatment
The control group	Active comparator	conventional dysphagia treatment Receives: Other: conventional dysphagia treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: day 1

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: day 1 and day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202331 Dec 2023

First posted25 Jan 2024
Study start30 May 2023
Primary completion29 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lateral Medullary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06224686
Sponsor's protocol ID: 2020-PT310-01
Status last verified: Jan 2024
First submitted: 6 Jan 2024
Last updated: 25 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect and Mechanism of Motor Imagery Based on Action Observation Treatment on Dysphagia in Wallenberg Syndrome
ClinicalTrials.gov ID: NCT06224686
Acronym / sponsor ID: 2020-PT310-01
Conditions: Lateral Medullary Syndrome, Deglutition Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Le WangUniversity, hospital or other
Study start: 30 May 2023 (actual)
Primary completion: 29 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 25 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The experimental group	Experimental	Other: conventional dysphagia treatment, Other: motor imagery based on action observation treatmentconventional dysphagia treatment and motor imagery based on action observation treatment
The control group	Active comparator	Other: conventional dysphagia treatmentconventional dysphagia treatment

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
conventional dysphagia treatmentConventional 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	The control group, The experimental group
motor imagery based on action observation treatmentFirst, 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.	Other	The experimental group

Primary outcome

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.
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.
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.

4 secondary outcomes

Murray secretion scale
Time frame: day 1 and day 14
yale pharyngeal residue severity rating scale
Time frame: day 1 and day 14
Rosenbek penetration-aspiration scale
Time frame: day 1 and day 14
swallowing-quality of life
Time frame: day 1 and day 14

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Individual participant dataSharing planned: No. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xi Zeng study director

The First Affiliated Hospital of Zhengzhou University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

standardized swallowing assessment (time frame: day 1 and day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06224686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.