Multiple SclerosisNCT07331350
Exercise Balance Program for Fall Prevention in Multiple Sclerosis
A study testing Combined Otago-Based and Game-Inspired Balance Training and Otago Exercise Program only in people with Multiple Sclerosis, run by International Hellenic University at 1 site in Greece.
Trial summary
Falls and balance impairments are common in individuals with multiple sclerosis (MS) and may negatively affect mobility, independence, confidence in daily activities, and quality of life, while increasing the risk of injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Combined Otago-Based and Game-Inspired Balance Training and Otago Exercise Program only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of multiple sclerosis according to the 2010 McDonald criteria.
- Age between 18 and 65 years.
- Ability to ambulate independently with or without an assistive device.
- Ability to understand and follow exercise instructions.
- Written informed consent prior to participation.
Who cannot join
- Presence of other neurological, musculoskeletal, or medical conditions that could significantly affect balance or mobility.
- Acute relapse of multiple sclerosis at the time of enrollment.
- Participation in another structured balance or fall-prevention program during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Otago-Based Exercise and Game-Inspired Balance Training Program on Balance, Mobility, and Fall-Related Outcomes in Individuals With Multiple Sclerosis: A Randomized Controlled Trial
Falls and balance impairments are common in individuals with multiple sclerosis (MS) and may negatively affect mobility, independence, confidence in daily activities, and quality of life, while increasing the risk of injury. This randomized controlled trial investigated the effects of a 6-week combined Otago-based and game-inspired balance-training program on static balance, functional mobility, fear of falling, and perceived walking ability in individuals with MS. Thirty participants with MS were randomly allocated to either an intervention group or an active control group. Both groups received fall-prevention counselling and performed home-based Otago-related exercises three times per week. The intervention group additionally received one supervised balance-training session per week using colored-circle and Twister-inspired task-oriented exercises. Outcomes were assessed at baseline and immediately after the intervention period using the FICSIT-4 for static balance, the Timed Up and Go test for functional mobility, the Falls Efficacy Scale-International (FES-I) for fear of falling, and the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for perceived walking limitations.
Read the detailed description
Falls are a common and clinically significant problem in individuals with multiple sclerosis (MS), primarily associated with impairments in balance, mobility, muscle strength, sensory function, and neuromuscular coordination. Exercise-based interventions focusing on balance, strengthening, functional mobility, and fall-prevention education constitute a core component of physiotherapeutic fall-prevention strategies; however, the optimal structure, intensity, and clinical implementation of such programs for individuals with MS remain under investigation.
This randomized controlled trial investigated the effects of a 6-week combined Otago-based and game-inspired balance-training program on static balance, functional mobility, fear of falling, and perceived walking ability in individuals with MS. A total of 30 adults with a confirmed diagnosis of MS were randomly allocated to either an intervention group or an active control group using a parallel-group design.
Both groups received fall-prevention counselling and performed home-based Otago-related exercises three times per week. The active control group followed the home-based Otago-related exercise program supported by instructional video material, without supervised sessions or additional task-oriented balance-training activities. The intervention group, in addition to performing the same home-based Otago-related exercises, participated in one supervised physiotherapy session per week. During these supervised sessions, participants performed progressively challenging colored-circle and Twister-inspired task-oriented balance exercises designed to challenge static and dynamic postural control, enhance neuromuscular coordination, promote visuomotor integration, improve reaction speed, and support adaptability to changing motor demands.
Outcome assessments were conducted at baseline and immediately after completion of the 6-week intervention period. Static balance was assessed using the FICSIT-4, functional mobility was evaluated with the Timed Up and Go test, fear of falling was measured using the Falls Efficacy Scale-International (FES-I), and perceived walking ability was assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12).
This study was designed to contribute to a better understanding of exercise-based fall-prevention strategies for individuals with MS and to inform the development of targeted rehabilitation programs aimed at improving balance and mobility in this population.
- Conditions
- Multiple Sclerosis
- Being tested
- Combined Otago-Based and Game-Inspired Balance Training, Otago Exercise Program only
- Keywords
- Accidental Falls, Balance Impairment, Physiotherapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Otago-Based and Game-Inspired Balance TrainingOther
This intervention combined home-based Otago-related exercises with supervised task-oriented balance training. The home-based component included selected balance and lower-limb strengthening exercises performed three times per week. The supervised component was delivered once weekly and included exercises with colored floor markers, postural tasks linked to color cues, and Twister-inspired stepping activities. These tasks were used to challenge postural control, coordination, visuomotor responses, and movement adaptability.
Otago Exercise Program onlyOther
This intervention consisted of selected Otago-related balance and lower-limb strengthening exercises performed at home three times per week for 6 weeks. Participants also received fall-prevention counselling and instructional material for home practice. No supervised colored-marker or Twister-inspired balance tasks were included.
| Study group | Role | What they receive |
|---|---|---|
| Combined Otago-Based and Game-Inspired Balance Training | Experimental | Participants in the intervention group received fall-prevention counselling and performed home-based Otago-related exercises three times per week for 6 weeks. In addition, they attended one supervised physiotherapy session per week, during which they performed colored-circle and Twister-inspired task-oriented balance exercises. Receives: Other: Combined Otago-Based and Game-Inspired Balance Training |
| Home-Based Otago-Related Exercises and Fall-Prevention Counselling | Active comparator | This intervention consisted of selected Otago-related balance and lower-limb strengthening exercises performed at home three times per week for 6 weeks. Participants also received fall-prevention counselling and instructional material for home practice. No supervised colored-marker or Twister-inspired balance tasks were included. Receives: Other: Otago Exercise Program only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance (FICSIT-4)
Static balance was assessed using the FICSIT-4. Participants attempted to maintain progressively challenging standing positions, including feet together, semi-tandem stance, tandem stance, and single-leg stance, for up to 10 seconds each. The outcome was recorded as a total score, with higher values indicating better static balance.
Measured: Baseline and immediately after completion of the 6-week intervention
Secondary outcomes (3)
Functional Mobility (Timed Up and Go Test)
Functional mobility was assessed using the Timed Up and Go (TUG) test. Participants were instructed to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down at a comfortable and safe pace. The time required to complete the task was recorded in seconds. Shorter completion times indicated better functional mobility.
Measured: Baseline and immediately after completion of the 6-week intervention
Fear of Falling (Falls Efficacy Scale-International)
Fear of falling was assessed using the Falls Efficacy Scale-International (FES-I), a validated self-reported questionnaire consisting of 16 items that assess concern about falling during a range of daily activities. Each item was scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicated greater concern about falling.
Measured: Baseline and immediately after completion of the 6-week intervention
Walking Limitations (12-item Multiple Sclerosis Walking Scale)
Perceived walking limitations were assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12), a disease-specific, self-reported questionnaire that evaluates the impact of multiple sclerosis on walking ability. Items were scored on a Likert scale and transformed to a total score ranging from 0 to 100, with higher scores indicating greater walking impairment.
Measured: Baseline and immediately after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Feb 2026
- Primary completion10 May 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
- Investigators
- Dimitrios Lytras, PhD, Principal investigator, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331350
- Sponsor's protocol ID
- EC-1/2026
- Status last verified
- May 2026
- First submitted
- 28 Dec 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Otago-Based Exercise and Game-Inspired Balance Training Program on Balance, Mobility, and Fall-Related Outcomes in Individuals With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07331350
- Acronym / sponsor ID
- EC-1/2026
- Conditions
- Multiple Sclerosis
- Keywords
- Accidental Falls, Balance Impairment, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls and balance impairments are common in individuals with multiple sclerosis (MS) and may negatively affect mobility, independence, confidence in daily activities, and quality of life, while increasing the risk of injury. This randomized controlled trial investigated the effects of a 6-week combined Otago-based and game-inspired balance-training program on static balance, functional mobility, fear of falling, and perceived walking ability in individuals with MS. Thirty participants with MS were randomly allocated to either an intervention group or an active control group. Both groups received fall-prevention counselling and performed home-based Otago-related exercises three times per week. The intervention group additionally received one supervised balance-training session per week using colored-circle and Twister-inspired task-oriented exercises. Outcomes were assessed at baseline and immediately after the intervention period using the FICSIT-4 for static balance, the Timed Up and Go test for functional mobility, the Falls Efficacy Scale-International (FES-I) for fear of falling, and the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for perceived walking limitations.
Detailed description
Falls are a common and clinically significant problem in individuals with multiple sclerosis (MS), primarily associated with impairments in balance, mobility, muscle strength, sensory function, and neuromuscular coordination. Exercise-based interventions focusing on balance, strengthening, functional mobility, and fall-prevention education constitute a core component of physiotherapeutic fall-prevention strategies; however, the optimal structure, intensity, and clinical implementation of such programs for individuals with MS remain under investigation.
This randomized controlled trial investigated the effects of a 6-week combined Otago-based and game-inspired balance-training program on static balance, functional mobility, fear of falling, and perceived walking ability in individuals with MS. A total of 30 adults with a confirmed diagnosis of MS were randomly allocated to either an intervention group or an active control group using a parallel-group design.
Both groups received fall-prevention counselling and performed home-based Otago-related exercises three times per week. The active control group followed the home-based Otago-related exercise program supported by instructional video material, without supervised sessions or additional task-oriented balance-training activities. The intervention group, in addition to performing the same home-based Otago-related exercises, participated in one supervised physiotherapy session per week. During these supervised sessions, participants performed progressively challenging colored-circle and Twister-inspired task-oriented balance exercises designed to challenge static and dynamic postural control, enhance neuromuscular coordination, promote visuomotor integration, improve reaction speed, and support adaptability to changing motor demands.
Outcome assessments were conducted at baseline and immediately after completion of the 6-week intervention period. Static balance was assessed using the FICSIT-4, functional mobility was evaluated with the Timed Up and Go test, fear of falling was measured using the Falls Efficacy Scale-International (FES-I), and perceived walking ability was assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12).
This study was designed to contribute to a better understanding of exercise-based fall-prevention strategies for individuals with MS and to inform the development of targeted rehabilitation programs aimed at improving balance and mobility in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Otago-Based and Game-Inspired Balance Training | Experimental | Other: Combined Otago-Based and Game-Inspired Balance TrainingParticipants in the intervention group received fall-prevention counselling and performed home-based Otago-related exercises three times per week for 6 weeks. In addition, they attended one supervised physiotherapy session per week, during which they performed colored-circle and Twister-inspired task-oriented balance exercises. |
| Home-Based Otago-Related Exercises and Fall-Prevention Counselling | Active comparator | Other: Otago Exercise Program onlyThis intervention consisted of selected Otago-related balance and lower-limb strengthening exercises performed at home three times per week for 6 weeks. Participants also received fall-prevention counselling and instructional material for home practice. No supervised colored-marker or Twister-inspired balance tasks were included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of multiple sclerosis according to the 2010 McDonald criteria.
- Age between 18 and 65 years.
- Ability to ambulate independently with or without an assistive device.
- Ability to understand and follow exercise instructions.
- Written informed consent prior to participation.
Key exclusion criteria (3 listed)
- Presence of other neurological, musculoskeletal, or medical conditions that could significantly affect balance or mobility.
- Acute relapse of multiple sclerosis at the time of enrollment.
- Participation in another structured balance or fall-prevention program during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Otago-Based and Game-Inspired Balance TrainingThis intervention combined home-based Otago-related exercises with supervised task-oriented balance training. The home-based component included selected balance and lower-limb strengthening exercises performed three times per week. The supervised component was delivered once weekly and included exercises with colored floor markers, postural tasks linked to color cues, and Twister-inspired stepping activities. These tasks were used to challenge postural control, coordination, visuomotor responses, and movement adaptability. | Other | Combined Otago-Based and Game-Inspired Balance Training |
| Otago Exercise Program onlyThis intervention consisted of selected Otago-related balance and lower-limb strengthening exercises performed at home three times per week for 6 weeks. Participants also received fall-prevention counselling and instructional material for home practice. No supervised colored-marker or Twister-inspired balance tasks were included. | Other | Home-Based Otago-Related Exercises and Fall-Prevention Counselling |
Primary outcome
Balance Performance (FICSIT-4)
Time frame: Baseline and immediately after completion of the 6-week intervention
Static balance was assessed using the FICSIT-4. Participants attempted to maintain progressively challenging standing positions, including feet together, semi-tandem stance, tandem stance, and single-leg stance, for up to 10 seconds each. The outcome was recorded as a total score, with higher values indicating better static balance.
3 secondary outcomes
Functional Mobility (Timed Up and Go Test)
Time frame: Baseline and immediately after completion of the 6-week intervention
Fear of Falling (Falls Efficacy Scale-International)
Time frame: Baseline and immediately after completion of the 6-week intervention
Walking Limitations (12-item Multiple Sclerosis Walking Scale)
Time frame: Baseline and immediately after completion of the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Lytras, PhD principal investigator
International Hellenic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Otago-Based and Game-Inspired Balance Training and Otago Exercise Program only in people with Multiple Sclerosis, run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Performance (FICSIT-4) (time frame: Baseline and immediately after completion of the 6-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.