Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video game-based physical activity training
Conventional physiotherapy program
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Relapsing-remitting or secondary progressive type of multiple sclerosis,
- Being able to walk at least 100 meters without resting,
- Being able to stably stand for half an hour,
- To be willing to participate in the study.
Exclusion Criteria:
- Having neurological disorder other than multiple sclerosis
- Orthopaedic surgery history covering the foot, ankle, knee, hip, or spine, affecting balance and walking
Sites / Locations
- Dokuz Eylul University Hospital, Neurology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video game-based physical activity training
Conventional physiotherapy program
Arm Description
Outcomes
Primary Outcome Measures
Feasibility - Recruitment process: Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
Acceptability - Prospective acceptability: Barriers (screening interview).
Barriers (screening interview). Burden (reasons for not taking part/discontinuation or dropping out).
Acceptability - Intervention coherence and adherence: Number of sessions attended.
Number of sessions attended.
Acceptability - Experience (satisfaction, perceptions): Qualitative interview
Qualitative interview (end of program).
Secondary Outcome Measures
Timed 25-Foot Walk
The Timed 25-Foot Walk is a quantitative mobility and leg function performance test. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average time of the two completed trials. Higher time represents slower walking speed and more walking impairment.
12-Item Multiple Sclerosis Walking Scale
The 12-Item Multiple Sclerosis Walking Scale is a patient-reported outcome measure that assesses the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. The total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.
Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. A higher score indicates higher level of fatigue.
2-Minute Walk Test
The 2-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 2 minutes. The goal is for the individual to walk as far and fast as possible in 2 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.
Six-Spot Step Test
Six-Spot Step Test reflects a complex array of sensorimotor functions, part of which are lower limb strength, spasticity, and coordination, as well as balance. The score is the average time of the four completed trials. Higher time represents more walking impairment.
Nine-Hole Peg Test
The Nine-Hole Peg Test is used to assess manual dexterity performance. It requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Two trials for each hand are performed and the score is the average time. Higher scores indicate less manual dexterity performance.
Manual Ability Measure-36
The Manual Ability Measurement-36 is a questionnaire on perceived ease or difficulty that a persons may experience when performing unilateral and bilateral activity of daily living tasks. During a semi-structured interview, the persons are asked to rate 36 unilateral and bilateral activity of daily living tasks using a 4-point scale. The score of the different tasks are summed up and transformed using a Rasch-derived conversion table. The Rasch-derived scores are ranged from 0 to 100. Higher scores indicate better manual ability.
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Multiple Sclerosis International Quality of Life Questionnaire
The Multiple Sclerosis International Quality of Life Questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with the healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level.
Hospital Anxiety and Depression Scale - Anxiety
The scale aims to measure symptoms of generalized anxiety disorder and consists of 7 items. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate higher symptoms.
Hospital Anxiety and Depression Scale - Depression
The scale aims to measure symptoms of depression and consists of 7 items, seven items. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate higher symptoms.
Symbol Digit Modalities Test
The Symbol Digit Modalities Test is used to assess information processing speed. Using a reference key, the test taker has 90 seconds to pair specific numbers with given geometric figures in the Symbol Digit Modalities Test. The correct matches are calculated as the test score. Higher scores indicate better information processing speed.
California Verbal Learning Test-II
The California Verbal Learning Test-II is used to assess verbal memory. Higher scores indicate better verbal memory.
Revised Brief Visuospatial Memory Test
The Revised Brief Visuospatial Memory Test is used to assess visuospatial memory. Higher scores indicate better visuospatial memory.
Paced Auditory Serial Addition Test
The Paced Auditory Serial Addition Test is used to assess auditory information processing speed and flexibility, as well as calculation ability. The score for the Paced Auditory Serial Addition Test is the total number correct out of 60 possible answers. Higher scores indicate higher cognitive function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04125823
Brief Title
Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment
Official Title
Effects of Video Game-based Physical Activity Training in People With Multiple Sclerosis in the Inpatient Period During Relapse Treatment: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to investigate the feasibility and acceptability of the video game-based physical activity training program in the inpatient period during relapse treatment. The secondary aims are to investigate its effectiveness on upper extremity functions, walking, balance, cognitive functions, quality of life, depression, and fatigue comparing to conventional rehabilitation in persons with multiple sclerosis.
Detailed Description
Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system. The most common clinical signs and symptoms are fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.
Current medical treatment is divided into three groups: disease-modifying, symptom management, and prognosis and relapse management. Intravenous methylprednisolone treatment is generally used in the management of relapses and prognosis. It is also thought that physiotherapy during the intravenous methylprednisolone treatment provides better treatment results. Therefore, treatment planning of people with MS during hospitalization should be done by a multidisciplinary team.
Studies have shown that video games based physical activity training as a non-pharmacological therapy may be an effective method for managing symptoms such as balance, gait, fatigue, and cognitive functions in people with MS, but its feasibility in the inpatient period is unknown.
The primary aim of the study is to investigate the feasibility and acceptability of the video game-based physical activity training program in the inpatient period. The secondary aims are to investigate its effectiveness on upper extremity functions, walking, balance, cognitive functions, quality of life, depression, and fatigue in persons with MS comparing to conventional rehabilitation.
Volunteers from people with MS who are in the inpatient period due to relapse in the Neurology Department, Faculty of Medicine, Dokuz Eylül University will participate in the study. In accordance with the inclusion criteria, 30 patients were randomly assigned to two groups: 15 patients in the game-based rehabilitation group and 15 patients in the conventional rehabilitation group. Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with a motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades and types of games will be changed. A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. Treatments will be given by the physiotherapist for 45 minutes once daily during the hospital stay. Evaluations will be made before and after the treatment (discharge) and 4 weeks after the end of treatment. Physical and clinical evaluations will be made by physicians and physiotherapists, and cognitive evaluation will be performed by psychologists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video game-based physical activity training
Arm Type
Experimental
Arm Title
Conventional physiotherapy program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Video game-based physical activity training
Intervention Description
Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with a motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades and types of games will be changed.
Sessions will be performed by a physiotherapist for 45 minutes once a day during the hospital stay.
Intervention Type
Behavioral
Intervention Name(s)
Conventional physiotherapy program
Intervention Description
A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented.
Sessions will be performed by a physiotherapist for 45 minutes once a day during the hospital stay.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment process: Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
Description
Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Acceptability - Prospective acceptability: Barriers (screening interview).
Description
Barriers (screening interview). Burden (reasons for not taking part/discontinuation or dropping out).
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Acceptability - Intervention coherence and adherence: Number of sessions attended.
Description
Number of sessions attended.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days
Title
Acceptability - Experience (satisfaction, perceptions): Qualitative interview
Description
Qualitative interview (end of program).
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days
Secondary Outcome Measure Information:
Title
Timed 25-Foot Walk
Description
The Timed 25-Foot Walk is a quantitative mobility and leg function performance test. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average time of the two completed trials. Higher time represents slower walking speed and more walking impairment.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
12-Item Multiple Sclerosis Walking Scale
Description
The 12-Item Multiple Sclerosis Walking Scale is a patient-reported outcome measure that assesses the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. The total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Modified Fatigue Impact Scale
Description
The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. A higher score indicates higher level of fatigue.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
2-Minute Walk Test
Description
The 2-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 2 minutes. The goal is for the individual to walk as far and fast as possible in 2 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Six-Spot Step Test
Description
Six-Spot Step Test reflects a complex array of sensorimotor functions, part of which are lower limb strength, spasticity, and coordination, as well as balance. The score is the average time of the four completed trials. Higher time represents more walking impairment.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Nine-Hole Peg Test
Description
The Nine-Hole Peg Test is used to assess manual dexterity performance. It requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Two trials for each hand are performed and the score is the average time. Higher scores indicate less manual dexterity performance.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Manual Ability Measure-36
Description
The Manual Ability Measurement-36 is a questionnaire on perceived ease or difficulty that a persons may experience when performing unilateral and bilateral activity of daily living tasks. During a semi-structured interview, the persons are asked to rate 36 unilateral and bilateral activity of daily living tasks using a 4-point scale. The score of the different tasks are summed up and transformed using a Rasch-derived conversion table. The Rasch-derived scores are ranged from 0 to 100. Higher scores indicate better manual ability.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Epworth Sleepiness Scale
Description
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Multiple Sclerosis International Quality of Life Questionnaire
Description
The Multiple Sclerosis International Quality of Life Questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with the healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Hospital Anxiety and Depression Scale - Anxiety
Description
The scale aims to measure symptoms of generalized anxiety disorder and consists of 7 items. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate higher symptoms.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Hospital Anxiety and Depression Scale - Depression
Description
The scale aims to measure symptoms of depression and consists of 7 items, seven items. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate higher symptoms.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Symbol Digit Modalities Test
Description
The Symbol Digit Modalities Test is used to assess information processing speed. Using a reference key, the test taker has 90 seconds to pair specific numbers with given geometric figures in the Symbol Digit Modalities Test. The correct matches are calculated as the test score. Higher scores indicate better information processing speed.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
California Verbal Learning Test-II
Description
The California Verbal Learning Test-II is used to assess verbal memory. Higher scores indicate better verbal memory.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Revised Brief Visuospatial Memory Test
Description
The Revised Brief Visuospatial Memory Test is used to assess visuospatial memory. Higher scores indicate better visuospatial memory.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Title
Paced Auditory Serial Addition Test
Description
The Paced Auditory Serial Addition Test is used to assess auditory information processing speed and flexibility, as well as calculation ability. The score for the Paced Auditory Serial Addition Test is the total number correct out of 60 possible answers. Higher scores indicate higher cognitive function.
Time Frame
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsing-remitting or secondary progressive type of multiple sclerosis,
Being able to walk at least 100 meters without resting,
Being able to stably stand for half an hour,
To be willing to participate in the study.
Exclusion Criteria:
Having neurological disorder other than multiple sclerosis
Orthopaedic surgery history covering the foot, ankle, knee, hip, or spine, affecting balance and walking
Facility Information:
Facility Name
Dokuz Eylul University Hospital, Neurology Department
City
Izmir
ZIP/Postal Code
35430
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment
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