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Not yet recruitingNCT06303882Updated Mar 15, 2024

Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke

An interventional study of routine rehabilitation treatment and Computer-assisted Cognitive Function Training in Dysphagia, sponsored by Muhammad. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Muhammad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Read the detailed description

Computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

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Conditions studied

  • Dysphagia

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years.
  • Meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging.
  • Montreal Cognitive Assessment score \< 26 and > 18 (adjusted by 1 point if the educational level is high school graduation or above).
  • Confirmed swallowing disorder through Fiberoptic Endoscopic Examination of Swallowing.
  • Duration of illness greater than three months.
  • Patients or their family members are aware of and consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Presence of other intracranial lesions, such as stroke.
  • Cognitive impairment caused by other diseases.
  • Mental abnormalities.
  • Inability to complete treatment and assessments due to other impairments.
  • Concurrent severe injuries.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Computer-assisted Cognitive Function Training+routine rehabilitation treatment

    In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment. The experimental group additionally underwent computer-assisted cognitive training, which generated training content of corresponding difficulty based on the patient's cognitive impairment assessment results. The training was conducted seven days a week, once a day, for a duration of 30-45 minutes per session.

    Behavioral: routine rehabilitation treatment · Behavioral: Computer-assisted Cognitive Function Training

  • Active comparator
    routine rehabilitation treatment+conventional cognitive training

    In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment.The control group was given conventional cognitive training.

    Behavioral: routine rehabilitation treatment · Behavioral: conventional cognitive training

Interventions

  • Behavioralroutine rehabilitation treatment

    The routine rehabilitation treatment included intervention for risk factors (such as blood pressure, blood lipids, and blood glucose control, restriction of smoking and alcohol, exercise, etc.) Besides, the patients with stable vital signs were scheduled for specialized rehabilitation training upon enrollment, and targeted rehabilitation programs were selected, conducted by experienced rehabilitation therapists.

  • BehavioralComputer-assisted Cognitive Function Training

    Based on the patient's cognitive impairment assessment results, the training content includes Attention game training, Executive function program training, Logical reasoning training, Agility training, Memory training. The training is conducted seven days a week, once a day, for a duration of 30-45 minutes per session

  • Behavioralconventional cognitive training

    including Memory training, attention training, and executive function training were conducted 2-5 times per week, lasting for 30-60 minutes each session, based on the patient's condition.

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What researchers measure

Primary outcomes

  1. Montreal Cognitive Assessment

    The Montreal Cognitive Assessment is used for assessing cognitive function.The total score on the test is 30, the higher scores indicating the higher cognitive function The total score ranged from 0 to 30.

    Time frame: day 1 and day 15

Secondary outcomes

  1. The coordination of swallowing

    Observation of the coordination of laryngeal and vocal fold movements. Results are categorized as normal/abnormal.

    Time frame: day 1 and day 15

  2. Penetration-Aspiration Scale

    Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased. The higher scores indicating worse swallowing function The total score ranged from 0 to 8.

    Time frame: day 1 and day 15

  3. Swallowing duration

    The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the was recorded.Unit: seconds.

    Time frame: day 1 and day 15

  4. Swallowing reflex

    Observation of the ability to initiate swallowing movements during eating, manifested by the white-out phenomenon seen under flexible laryngoscopy. Results are categorized as normal or abnormal.

    Time frame: day 1 and day 15

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT06303882
Lead sponsor
Muhammad
Responsible party
Muhammad (Research Director, Ahmadu Bello University Teaching Hospital) — Sponsor-investigator
First posted
Mar 12, 2024
Start date
Mar 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Lavie Ce, Master
Contact
zenghongjixx@qq.com
15333828388
Nieto Luis, Master
study chair · Site Coordinator of United Medical Group located in Miami

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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