Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Oct 2019
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 14, 2019
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedJune 1, 2022
May 1, 2022
2.2 years
October 10, 2019
May 30, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Acceptability - Prospective acceptability: Barriers (screening interview).
Barriers (screening interview). Burden (reasons for not taking part/discontinuation or dropping out).
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Acceptability - Intervention coherence and adherence: Number of sessions attended.
Number of sessions attended.
Change from Baseline through Hospital Discharge, up to 10 days
Acceptability - Experience (satisfaction, perceptions): Qualitative interview
Qualitative interview (end of program).
Change from Baseline through Hospital Discharge, up to 10 days
Secondary Outcomes (15)
Timed 25-Foot Walk
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
12-Item Multiple Sclerosis Walking Scale
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Modified Fatigue Impact Scale
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
2-Minute Walk Test
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Six-Spot Step Test
Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
- +10 more secondary outcomes
Study Arms (2)
Video game-based physical activity training
EXPERIMENTALConventional physiotherapy program
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Having neurological disorder other than multiple sclerosis
- Orthopaedic surgery history covering the foot, ankle, knee, hip, or spine, affecting balance and walking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylul University Hospital, Neurology Department
Izmir, 35430, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 14, 2019
Study Start
October 23, 2019
Primary Completion
January 15, 2022
Study Completion
February 15, 2022
Last Updated
June 1, 2022
Record last verified: 2022-05