Back to resultsEffectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia
Primary Purpose
Deglutition Disorders, Rehabilitation, Video Game
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video-game
Conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Deglutition Disorders
Eligibility Criteria
Inclusion Criteria: first-episode stroke, as confirmed by brain CT or MRI; diagnosis of dysphagia after stroke according to the Toronto Bedside Swallowing Screening Test (TOR-BSST); age between 18 and 80 years; no significant cognitive impairment, able to execute instructions correctly, and with Mini-Mental State Examination (MMSE) score ≥ 24; clear consciousness as assessed by the National Institute of Health stroke scale (NIHSS). Exclusion Criteria: dysphagia caused by structural lesions (eg, radiotherapy, previous extensive surgery of the head and neck region such as laryngectomy and cordectomy); combined with serious heart, lung, liver, kidney diseases, and hematological disorders; limb deficiency or paralysis, blindness in both eyes, severe visual impairments; motion sickness or vestibular dysfunction; history of epilepsy, malignancy or other neurological diseases; pregnancy or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video-game group
Conventional therapy group
Arm Description
Received the video-game intervention
Received the conventional therapy intervention
Outcomes
Primary Outcome Measures
the Toronto Bedside Swallowing Screening Test (TOR-BSST)
The Toronto Bedside Swallowing Screening Test (TOR-BSST) is the best performing water swallow screening tool 8 with a sensitivity of 91.3%, a negative predictive value of 93.3% in the acute phase and 89.5% in the recovery phase. TOR-BSST has shown to be more convenient and cheaper in bedside screening compared to the gold standard method of simultaneous videofluoroscopy (VFSS), which is an invasive assessment. Due to the limitations of the experimental site, the investigators chose TOR-BSST as the assessment tool for dysphagia.
the Functional Oral Intake Scale (FOIS)
The Functional Oral Intake Scale consists of a 7-point scale, with level 1 indicating completely impaired oral intake and level 7 indicating complete oral intake regardless of food concentration or type. Scores range from 1 to 7, the higher point means that the participant's oral intake is better.
Secondary Outcome Measures
The swallowing quality of life (SWAL-QOL) questionnaire
The swallowing quality of life (SWAL-QOL) questionnaire consists of 10 subscales and a symptom scale (14 items) to assess the severity of dysphagia symptoms. Scores range from 0 to 100, with lower scores indicating greater impairment of quality of life from dysphagia
The acceptance survey questionnaire
The acceptance survey questionnaire was self-designed based on reference to relevant literature, and was repeatedly modified by experts, and consisted of two parts: (1) Basic information: including age, gender, education level, type of work, and disease; (2) Acceptance of video-game based swallowing training: the widely used Technology Acceptance Model (TAM) as a theoretical model , seven dimensions of perceived usefulness, perceived ease of use, perceived ease of learning, perceived applicability, perceived safety, perceived satisfaction, and intension to use, with five questions under each dimension, each scored on a scale of 1 to 5, with 1 being "strongly disagree", 2 being "basically disagree", 3 being "unsure", 4 being "basically agree", and 5 being "strongly agree" , Scores range from 15 to 75, with higher scores indicating that participants are more receptive to video games.
Body mass index (BMI)
Body mass index is one of the most commonly used nutritional assessments among adults.BMI is equal to weight (kg) divided by height (meters squared). Under normal conditions, the BMI is generally between 18 and 24 as normal. When it is lower than 18, it is called underweight; when it is more than 24, it is called overweight; when it is more than 28, it is called obese.
Mini Nutritional Assessment Short Form (MNA-SF)
Mini Nutritional Assessment Short Form (MNA-SF) were used to assess the nutritional status of the dysphagia patients. Scores range from 0 to 14, with >11 identified as malnutrition, ≤11 as normal.
The satisfaction questionnaire
The satisfaction questionnaire was designed based on the literatures. There are 15 items, involving 3 dimensions: training mode content setting, training mode format setting, and self-subjective feeling, and scored on a 5-point Likert scale. Scores range from 5 to 15. The higher the score, the more satisfied the patients were with the video-game training.
Adherence
Adherence was based on the actual completion of the patient's swallowing function training. The actual completion of the dysphagia training by patients, including the number of training sessions completed and the duration of training, was objectively recorded by the researcher. Adherence was considered good if the patient could complete more than 80% of the training sessions of the corresponding training program; average if the patient could complete 50% to 80% of the training sessions; and poor if the patient could complete less than 50% of the training sessions. Patients are considered to have completed their training when they have completed more than 12 training sessions.
Self-efficacy
The General Self-Efficacy Scale were used to assess participants' perceptions of learning, with 10 items and scores ranging from 10 to 50, with higher scores indicating higher self-efficacy among participants.
Learned helplessness
The Learned Helplessness Scale was used to assess participants' feelings of powerlessness over learning, with 18 items and scores ranging from 18 to 90, with higher scores indicating greater powerlessness over learning.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05978700
Brief Title
Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia
Official Title
Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia: a Randomized, Single-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZHANG Bohan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical trial is to investigate the effect of video-game on swallowing function in patients with dysphagia through a randomized controlled trial and whether it has additional benefits in improving swallowing function and training compliance compared with conventional training methods. The main questions it aims to answer are:
How effective is video-game based rehabilitation for dysphagia?
Whether video-game based has additional benefits in improving swallowing function and training compliance compared with conventional training methods Participants will be divided into two groups, with one group completing video game rehabilitation and one group completing conventional rehabilitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Rehabilitation, Video Game
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video-game group
Arm Type
Experimental
Arm Description
Received the video-game intervention
Arm Title
Conventional therapy group
Arm Type
Active Comparator
Arm Description
Received the conventional therapy intervention
Intervention Type
Device
Intervention Name(s)
Video-game
Intervention Description
The video-game has three games: (1) Game One - Lip Exercise; (2) Game Two - Tongue Exercises; (3) Game Three - Lower Jaw Exercise. The whole training will take about once a day for 30 min per session, 5 times a week for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Conventional therapy
Intervention Description
The control group used the conventional swallowing function training. The lip exercise consisted of the following specific movements: opening mouth, closing mouth, drumming cheeks, left drumming cheeks, and right drumming cheeks; the tongue exercise consisted of the following specific movements: extending the tongue, tongue up, tongue down, tongue left, and tongue right. Each specific movement in the steps lasts 2-3s, repeat 15 times and continue with the next movement. The lower jaw movement contains the following specific movements: keep the head as low as possible, and squeeze the rubber ball placed on the neck for 2-3 seconds, repeat 15 times.
Primary Outcome Measure Information:
Title
the Toronto Bedside Swallowing Screening Test (TOR-BSST)
Description
The Toronto Bedside Swallowing Screening Test (TOR-BSST) is the best performing water swallow screening tool 8 with a sensitivity of 91.3%, a negative predictive value of 93.3% in the acute phase and 89.5% in the recovery phase. TOR-BSST has shown to be more convenient and cheaper in bedside screening compared to the gold standard method of simultaneous videofluoroscopy (VFSS), which is an invasive assessment. Due to the limitations of the experimental site, the investigators chose TOR-BSST as the assessment tool for dysphagia.
Time Frame
Assessments were conducted at baseline, within 1 week post-training, and week 8.
Title
the Functional Oral Intake Scale (FOIS)
Description
The Functional Oral Intake Scale consists of a 7-point scale, with level 1 indicating completely impaired oral intake and level 7 indicating complete oral intake regardless of food concentration or type. Scores range from 1 to 7, the higher point means that the participant's oral intake is better.
Time Frame
Assessments were conducted at baseline, within 1 week post-training, and week 8.
Secondary Outcome Measure Information:
Title
The swallowing quality of life (SWAL-QOL) questionnaire
Description
The swallowing quality of life (SWAL-QOL) questionnaire consists of 10 subscales and a symptom scale (14 items) to assess the severity of dysphagia symptoms. Scores range from 0 to 100, with lower scores indicating greater impairment of quality of life from dysphagia
Time Frame
Assessments will be conducted at baseline, within 1 week post-training, and week 8.
Title
The acceptance survey questionnaire
Description
The acceptance survey questionnaire was self-designed based on reference to relevant literature, and was repeatedly modified by experts, and consisted of two parts: (1) Basic information: including age, gender, education level, type of work, and disease; (2) Acceptance of video-game based swallowing training: the widely used Technology Acceptance Model (TAM) as a theoretical model , seven dimensions of perceived usefulness, perceived ease of use, perceived ease of learning, perceived applicability, perceived safety, perceived satisfaction, and intension to use, with five questions under each dimension, each scored on a scale of 1 to 5, with 1 being "strongly disagree", 2 being "basically disagree", 3 being "unsure", 4 being "basically agree", and 5 being "strongly agree" , Scores range from 15 to 75, with higher scores indicating that participants are more receptive to video games.
Time Frame
Assessments will be conducted within 1 week post-training.
Title
Body mass index (BMI)
Description
Body mass index is one of the most commonly used nutritional assessments among adults.BMI is equal to weight (kg) divided by height (meters squared). Under normal conditions, the BMI is generally between 18 and 24 as normal. When it is lower than 18, it is called underweight; when it is more than 24, it is called overweight; when it is more than 28, it is called obese.
Time Frame
Assessments will be conducted at baseline, within 1 week post-training, and week 8.
Title
Mini Nutritional Assessment Short Form (MNA-SF)
Description
Mini Nutritional Assessment Short Form (MNA-SF) were used to assess the nutritional status of the dysphagia patients. Scores range from 0 to 14, with >11 identified as malnutrition, ≤11 as normal.
Time Frame
Assessments will be conducted at baseline, within 1 week post-training, and week 8.
Title
The satisfaction questionnaire
Description
The satisfaction questionnaire was designed based on the literatures. There are 15 items, involving 3 dimensions: training mode content setting, training mode format setting, and self-subjective feeling, and scored on a 5-point Likert scale. Scores range from 5 to 15. The higher the score, the more satisfied the patients were with the video-game training.
Time Frame
Assessments will be conducted within 1 week post-training.
Title
Adherence
Description
Adherence was based on the actual completion of the patient's swallowing function training. The actual completion of the dysphagia training by patients, including the number of training sessions completed and the duration of training, was objectively recorded by the researcher. Adherence was considered good if the patient could complete more than 80% of the training sessions of the corresponding training program; average if the patient could complete 50% to 80% of the training sessions; and poor if the patient could complete less than 50% of the training sessions. Patients are considered to have completed their training when they have completed more than 12 training sessions.
Time Frame
Assessments will be within 1 week post-training.
Title
Self-efficacy
Description
The General Self-Efficacy Scale were used to assess participants' perceptions of learning, with 10 items and scores ranging from 10 to 50, with higher scores indicating higher self-efficacy among participants.
Time Frame
Assessments will be conducted at baseline, within 1 week post-training.
Title
Learned helplessness
Description
The Learned Helplessness Scale was used to assess participants' feelings of powerlessness over learning, with 18 items and scores ranging from 18 to 90, with higher scores indicating greater powerlessness over learning.
Time Frame
Assessments will be conducted at baseline, within 1 week post-training.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first-episode stroke, as confirmed by brain CT or MRI;
diagnosis of dysphagia after stroke according to the Toronto Bedside Swallowing Screening Test (TOR-BSST);
age between 18 and 80 years;
no significant cognitive impairment, able to execute instructions correctly, and with Mini-Mental State Examination (MMSE) score ≥ 24;
clear consciousness as assessed by the National Institute of Health stroke scale (NIHSS).
Exclusion Criteria:
dysphagia caused by structural lesions (eg, radiotherapy, previous extensive surgery of the head and neck region such as laryngectomy and cordectomy);
combined with serious heart, lung, liver, kidney diseases, and hematological disorders;
limb deficiency or paralysis, blindness in both eyes, severe visual impairments;
motion sickness or vestibular dysfunction;
history of epilepsy, malignancy or other neurological diseases;
pregnancy or breastfeeding.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only PI and CI can use IPD.
Learn more about this trial
Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia
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