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Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke

T

The Second Affiliated Hospital of Dalian Medical University

Status

Enrolling

Conditions

Stroke

Treatments

Behavioral: Modified Air-pulse Stimulation
Behavioral: Conventional air-pulse stimulation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.

Enrollment

42 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;
  • patients with relatively stable vital signs, with a NIHSS score of 21 points;
  • patients with tracheotomy accompanied by dysphagia;
  • no previous history of dysphagia;
  • age ≥ 30 years and ≤80 years;
  • informed consent signed by the patient and his family.

Exclusion criteria

  • patients with medullary haemorrhage/infarction;
  • patients that experienced cerebral hernia and recurrent stroke;
  • patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;
  • patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;
  • patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;
  • patients with a history of epilepsy or risk of seizures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

control group
Sham Comparator group
Description:
Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.
Treatment:
Behavioral: Conventional air-pulse stimulation
trial group
Experimental group
Description:
The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.
Treatment:
Behavioral: Modified Air-pulse Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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