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Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exergaming
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A 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:

  • Another neurological disorder,
  • Relapse during the study period,
  • Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
  • Diagnosed severe cognitive and/or psychiatric impairment

Sites / Locations

  • MS Outpatient Clinic, Dokuz Eylul University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Exergaming, restless legs syndrome (+)

Exergaming, restless legs syndrome (-)

Control, restless legs syndrome (+)

Control, restless legs syndrome (-)

Arm Description

A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.

A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.

No specific intervention.

No specific intervention.

Outcomes

Primary Outcome Measures

International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.

Secondary Outcome Measures

Timed 25-Foot Walk
The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. 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 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 self-assessment scale which measures 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. 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 a 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. Higher score indicates higher level of fatigue.
Timed Up and Go test
The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.
6-Minute Walk Test
The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.
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'.
Godin Leisure Time Exercise Questionnaire
The Godin Leisure Time Exercise Questionnaire is a commonly used questionnaire to measure of usual physical activity in persons with multiple sclerosis. It contains three items that measure the frequency of strenuous, moderate, and mild physical activities for periods of more than 15 minutes during one's free time within a typical week. Weekly frequencies of strenuous, moderate and mild physical activity were multiplied by 9, 5 and 3 metabolic equivalents, respectively, and were summed to form a measure of the total leisure physical activity. Higher scores indicate higher level of physical activity.
Hospital Anxiety And Depression Scale - Anxiety
The scale aims to measure symptoms of generalized anxiety disorder 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.
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.
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 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.
Multiple Sclerosis-Related Symptom Checklist
Multiple Sclerosis-Related Symptom Checklist has 26 items that consist 5 subsections and 2 independent items. Sub-sections evaluate motor (7 items), brainstem (4 items), sensory (4 items), neuropsychiatric problems (3 items) and excretory problems (6 items). Independent items are related with fatigue and sleep difficulty. Responses are in the form of a 6-point Likert scale (None: 0, almost no: 1, sometimes: 2, usually: 3, almost always: 4, always: 5). The minimum score that can be taken from the scale is 0, the maximum score is 130, and the high score shows an increased symptom load.

Full Information

First Posted
February 4, 2019
Last Updated
May 30, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03878810
Brief Title
Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome
Official Title
Effects of Video Game-based Physical Activity Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (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
In this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.
Detailed Description
Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. Sleep disturbance is affecting more than 50% of persons with multiple sclerosis. Restless legs syndrome is one of the factors causing sleep disturbance in persons with multiple sclerosis. Studies have showed that the incidence of restless legs syndrome in persons with multiple sclerosis is about five times more than the general population. In order to increase and maintain the quality of life of persons with multiple sclerosis, the disease-related progressive symptoms need to be managed. Therefore, persons with multiple sclerosis need long-term rehabilitation. This situation reduces the motivation of the people over time and makes the continuity of treatment difficult. Developments in rehabilitation technology aim to contribute to the treatment process as well as to increase the active participation of individuals with chronic diseases. Current literature has shown that video-based physical activity training as non-pharmacological therapy may be an effective method for symptoms such as balance, walking, fatigue, cognitive functions in persons with multiple sclerosis, but the effects on restless legs syndrome are not known. The main aim of the study is to investigate the effects of 8-week video game-based physical activity training in persons with multiple sclerosis with restless legs syndrome. Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 68 participants will randomly be divided into 4 groups as exergaming group and control group with restless legs syndrome, exergaming group and control group without restless legs syndrome. A video game-based physical activity training will apply to exergaming groups by a physiotherapist for 2 days/week. The control groups will continue their routine treatment during the study. After the study, the treatment options will be offered to the participants. Assessments will done at baseline, after 8 weeks (post-treatment) and at 8 weeks (follow-up). Assessments will be done by assessors who are blinded to the group allocation.

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
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exergaming, restless legs syndrome (+)
Arm Type
Experimental
Arm Description
A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.
Arm Title
Exergaming, restless legs syndrome (-)
Arm Type
Experimental
Arm Description
A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.
Arm Title
Control, restless legs syndrome (+)
Arm Type
No Intervention
Arm Description
No specific intervention.
Arm Title
Control, restless legs syndrome (-)
Arm Type
No Intervention
Arm Description
No specific intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exergaming
Intervention Description
A video game-based physical activity training applied using a commercial game console.
Primary Outcome Measure Information:
Title
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
Description
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.
Time Frame
Change from Baseline at 8 and 16 weeks
Secondary Outcome Measure Information:
Title
Timed 25-Foot Walk
Description
The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. 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 of the two completed trials. Higher time represents slower walking speed and more walking impairment.
Time Frame
Change from Baseline at 8 and 16 weeks
Title
12-Item Multiple sclerosis walking scale
Description
The 12-Item Multiple sclerosis walking scale is a self-assessment scale which measures 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. Total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.
Time Frame
Change from Baseline at 8 and 16 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 a 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. Higher score indicates higher level of fatigue.
Time Frame
Change from Baseline at 8 and 16 weeks
Title
Timed Up and Go test
Description
The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.
Time Frame
Change from Baseline at 8 and 16 weeks
Title
6-Minute Walk Test
Description
The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.
Time Frame
Change from Baseline at 8 and 16 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 at 8 and 16 weeks
Title
Godin Leisure Time Exercise Questionnaire
Description
The Godin Leisure Time Exercise Questionnaire is a commonly used questionnaire to measure of usual physical activity in persons with multiple sclerosis. It contains three items that measure the frequency of strenuous, moderate, and mild physical activities for periods of more than 15 minutes during one's free time within a typical week. Weekly frequencies of strenuous, moderate and mild physical activity were multiplied by 9, 5 and 3 metabolic equivalents, respectively, and were summed to form a measure of the total leisure physical activity. Higher scores indicate higher level of physical activity.
Time Frame
Change from Baseline at 8 and 16 weeks
Title
Hospital Anxiety And Depression Scale - Anxiety
Description
The scale aims to measure symptoms of generalized anxiety disorder 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 at 8 and 16 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 at 8 and 16 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 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 at 8 and 16 weeks
Title
Multiple Sclerosis-Related Symptom Checklist
Description
Multiple Sclerosis-Related Symptom Checklist has 26 items that consist 5 subsections and 2 independent items. Sub-sections evaluate motor (7 items), brainstem (4 items), sensory (4 items), neuropsychiatric problems (3 items) and excretory problems (6 items). Independent items are related with fatigue and sleep difficulty. Responses are in the form of a 6-point Likert scale (None: 0, almost no: 1, sometimes: 2, usually: 3, almost always: 4, always: 5). The minimum score that can be taken from the scale is 0, the maximum score is 130, and the high score shows an increased symptom load.
Time Frame
Change from Baseline at 8 and 16 weeks
Other Pre-specified Outcome Measures:
Title
Restless Legs Syndrome Diagnostic Criteria
Description
Diagnostic Criteria for Restless Legs Syndrome was developed by the Restless Legs Syndrome Working Group in 1995 and revised in 2003 and 2014. These criteria include; the need to move the legs due to uncomfortable or unpleasant sensations in the legs, the need for movement or disturbing sensations start or worsen at rest, the need for movement or disturbing sensations can be partially or totally relieved by movements such as walking or stretching, the need for movement or disturbing sensations may worsen at night or only occur in the evening or night, The aforementioned features cannot be considered only in relation to primary symptoms or other medical or behavioral conditions (e.g., myalgia, venous stasis, leg edema, leg cramps, habitual foot swing). Patients meeting all of the criteria are diagnosed with restless legs syndrome. The restless legs syndrome diagnosis will be confirmed by a neurologist.
Time Frame
At Baseline
Title
Expanded Disability Status Scale
Description
The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.
Time Frame
At Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A 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: Another neurological disorder, Relapse during the study period, Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance, Diagnosed severe cognitive and/or psychiatric impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan Ozakbas, MD
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Study Director
Facility Information:
Facility Name
MS Outpatient Clinic, Dokuz Eylul University Hospital
City
Izmir
ZIP/Postal Code
35430
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome

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