Multiple SclerosisNCT04317716
A Self-management Program to Prevent Falls in People With Multiple Sclerosis
A study testing fall prevention program and Brochure about falls and fall risk factors in people with Multiple Sclerosis, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
This project's overall aim is to develop, deliver, and evaluate feasibility of a fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will use a comprehensive intervention approach to address a variety of fall risk factors, and utilise self-management strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- fall prevention program and Brochure about falls and fall risk factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSweden
- Study dates
- 11 Feb 2022to 17 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling adults aged ≥ 18 years
- Diagnosed with multiple sclerosis
- Able to independently transfer from bed to wheelchair with or without aids but without assistance of another person
- Able to understand and communicate in Swedish
- Able to use and access to technical devices for online meetings i.e., computers or tablets with internet access
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Academic Specialist Centre of Neurology
Stockholm
Karolinska University Hospital
Stockholm
About this study
Official title: A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis
This project's overall aim is to develop, deliver, and evaluate feasibility of a fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will use a comprehensive intervention approach to address a variety of fall risk factors, and utilise self-management strategies. Specific aims are to
- develop a fall prevention program, that addresses diverse fall risk factors and utilises self-management strategies, for ambulatory and non-ambulatory people with multiple sclerosis using a co-design process.
- To examine feasibility, acceptability, fidelity, and potential outcome of the online, co-designed self-management fall prevention intervention for ambulatory and non-ambulatory people with multiple sclerosis, and to examine feasibility of the recruitment process, the data collection procedures, and the outcome measures.
Read the detailed description
Falls among people with multiple sclerosis (PwMS) are common and associated with injuries, fear of falling and low health-related quality of life. Considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for PwMS. Thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention will be created specifically for ambulatory and non-ambulatory PwMS.
The feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. Findings will inform a future full-scale randomised controlled trial. A mixed-method design will be used. Forty-eight PwMS, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). Both groups will receive a brochure about fall risk factors and fall prevention. The intervention is group-based (eight PwMS in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. Each intervention group will be led by a trained facilitator.
Data collection will be performed at baseline, and after seven and 18 weeks. Outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of MS and number of falls. Feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. Both quantitative and qualitative methods will be used.
- Conditions
- Multiple Sclerosis
- Being tested
- fall prevention program, Brochure about falls and fall risk factors
- Keywords
- Feasibility Studies, Accidental Falls, Self-management, Complex Intervention, Group-based, Online Intervention, Short Message Service
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall prevention programBehavioural
The intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will be group-based with 6-8 participants, led by a facilitator, and performed online. It comprises six two-hour sessions held once a week, and a booster session held eight weeks after the sixth session. In addition they will receive a brochure about falls and fall risk factors.
Brochure about falls and fall risk factorsOther
Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Fall prevention program and brochure about falls and fall risk factors Receives: Behavioral: fall prevention program |
| Control | Other | Bbrochure about falls and fall risk factors Receives: Other: Brochure about falls and fall risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Prevention Strategy Survey
The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). The number of strategies used is calculated where a higher number of strategies indicate a better outcome
Measured: Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period
Fall Prevention Strategy Survey
The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). The number of strategies used is calculated where a higher number of strategies indicate a better outcome
Measured: Number of strategies used at 18 weeks after the start of the intervention/control period
Secondary outcomes (6)
Falls incidence
Falls will be monitored via an online short message service (SMS) and interview
Measured: Weekly from baseline to the 18-week follow-up
Measure of fear of falling
Questionnaire with one question "Are you afraid of falling?" and six response options: Not at all afraid, Somewhat afraid, Fairly afraid, Very afraid, Don't know, Refused
Measured: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Falls Efficacy Scale -International
Questionnaire that consists of 16 questions regarding 'how concerned' the person is when performing daily activities. Each question is answered with a four-graded scale (1-4); not at all concerned, somewhat concerned, fairly concerned and very concerned. A total score is calculated and ranges from 16 to 64
Measured: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Spinal Cord Injury Fall Concern Scale
Addresses concern about falling during 16 activities of daily living associated with falling, scored on a 4-point scale (1=not at all concerned to 4=very concerned. The total score is calculated by summing the scores for each activity, with a possible range between 16 and 64
Measured: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Multiple Sclerosis Impact Scale
29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of multiple sclerosis on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease
Measured: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Frenchay Activities Index
Measures frequency of social and everyday activities. The Frenchay Activities Index consists of 15 items and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start11 Feb 2022
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 4 will be used.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Forte, The Swedish Research Council
- Responsible party
- Principal investigator, Charlotte Ytterberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317716
- Sponsor's protocol ID
- 2019-00457
- Other IDs
- 2019
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results in a publication, after deidentification.
Publications
Kierkegaard M, Peterson E, Tuvemo Johnson S, Gottberg K, Johansson S, Elf M, Flink M, Ytterberg C. Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial. BMJ Open. 2022 Jul 8;12(7):e061325. doi: 10.1136/bmjopen-2022-061325.
PubMed 35803627Tuvemo Johnson S, Flink M, Peterson E, Gottberg K, Elf M, Johansson S, Kierkegaard M, Ytterberg C. Self-management of falls in people with multiple sclerosis: A scoping review. Clin Rehabil. 2023 Feb;37(2):162-176. doi: 10.1177/02692155221128723. Epub 2022 Sep 29.
PubMed 36177511Meijer U, Flink M, Tuvemo Johnson S, Kierkegaard M, Gottberg K, Ytterberg C. Preventing falls in multiple sclerosis: a qualitative study on user requirements for a self-management programme. Disabil Rehabil. 2025 Jan;47(2):398-405. doi: 10.1080/09638288.2024.2348725. Epub 2024 May 7.
PubMed 38711397Johnson ST, Ytterberg C, Peterson E, Johansson S, Kierkegaard M, Gottberg K, Flink M. Development of Fewer Falls in MS-An Online, Theory-Based, Fall Prevention Self-Management Programme for People With Multiple Sclerosis. Health Expect. 2024 Aug;27(4):e14154. doi: 10.1111/hex.14154.
PubMed 39032151
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04317716
- Acronym / sponsor ID
- 2019-00457
- Conditions
- Multiple Sclerosis
- Keywords
- Feasibility Studies, Accidental Falls, Self-management, Complex Intervention, Group-based, Online Intervention, Short Message Service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Forte, The Swedish Research Council
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 23 Mar 2020 (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.
This project's overall aim is to develop, deliver, and evaluate feasibility of a fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will use a comprehensive intervention approach to address a variety of fall risk factors, and utilise self-management strategies. Specific aims are to
- develop a fall prevention program, that addresses diverse fall risk factors and utilises self-management strategies, for ambulatory and non-ambulatory people with multiple sclerosis using a co-design process.
- To examine feasibility, acceptability, fidelity, and potential outcome of the online, co-designed self-management fall prevention intervention for ambulatory and non-ambulatory people with multiple sclerosis, and to examine feasibility of the recruitment process, the data collection procedures, and the outcome measures.
Detailed description
Falls among people with multiple sclerosis (PwMS) are common and associated with injuries, fear of falling and low health-related quality of life. Considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for PwMS. Thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention will be created specifically for ambulatory and non-ambulatory PwMS.
The feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. Findings will inform a future full-scale randomised controlled trial. A mixed-method design will be used. Forty-eight PwMS, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). Both groups will receive a brochure about fall risk factors and fall prevention. The intervention is group-based (eight PwMS in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. Each intervention group will be led by a trained facilitator.
Data collection will be performed at baseline, and after seven and 18 weeks. Outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of MS and number of falls. Feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. Both quantitative and qualitative methods will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 4 will be used.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: fall prevention programFall prevention program and brochure about falls and fall risk factors |
| Control | Other | Other: Brochure about falls and fall risk factorsBbrochure about falls and fall risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling adults aged ≥ 18 years
- Diagnosed with multiple sclerosis
- Able to independently transfer from bed to wheelchair with or without aids but without assistance of another person
- Able to understand and communicate in Swedish
- Able to use and access to technical devices for online meetings i.e., computers or tablets with internet access
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| fall prevention programThe intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will be group-based with 6-8 participants, led by a facilitator, and performed online. It comprises six two-hour sessions held once a week, and a booster session held eight weeks after the sixth session. In addition they will receive a brochure about falls and fall risk factors. | Behavioural | Intervention |
| Brochure about falls and fall risk factorsControl-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation. | Other | Control |
Primary outcome
Fall Prevention Strategy Survey
Time frame: Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period
The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). The number of strategies used is calculated where a higher number of strategies indicate a better outcome
Fall Prevention Strategy Survey
Time frame: Number of strategies used at 18 weeks after the start of the intervention/control period
The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). The number of strategies used is calculated where a higher number of strategies indicate a better outcome
6 secondary outcomes
Falls incidence
Time frame: Weekly from baseline to the 18-week follow-up
Measure of fear of falling
Time frame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Falls Efficacy Scale -International
Time frame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Spinal Cord Injury Fall Concern Scale
Time frame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Multiple Sclerosis Impact Scale
Time frame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Frenchay Activities Index
Time frame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
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 27 Mar 2026.
- Background: PubMed 35803627Kierkegaard M, Peterson E, Tuvemo Johnson S, Gottberg K, Johansson S, Elf M, Flink M, Ytterberg C. Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial. BMJ Open. 2022 Jul 8;12(7):e061325. doi: 10.1136/bmjopen-2022-061325.
- Results publication: PubMed 36177511Tuvemo Johnson S, Flink M, Peterson E, Gottberg K, Elf M, Johansson S, Kierkegaard M, Ytterberg C. Self-management of falls in people with multiple sclerosis: A scoping review. Clin Rehabil. 2023 Feb;37(2):162-176. doi: 10.1177/02692155221128723. Epub 2022 Sep 29.
- Results publication: PubMed 38711397Meijer U, Flink M, Tuvemo Johnson S, Kierkegaard M, Gottberg K, Ytterberg C. Preventing falls in multiple sclerosis: a qualitative study on user requirements for a self-management programme. Disabil Rehabil. 2025 Jan;47(2):398-405. doi: 10.1080/09638288.2024.2348725. Epub 2024 May 7.
- Results publication: PubMed 39032151Johnson ST, Ytterberg C, Peterson E, Johansson S, Kierkegaard M, Gottberg K, Flink M. Development of Fewer Falls in MS-An Online, Theory-Based, Fall Prevention Self-Management Programme for People With Multiple Sclerosis. Health Expect. 2024 Aug;27(4):e14154. doi: 10.1111/hex.14154.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results in a publication, after deidentification.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fall prevention program and Brochure about falls and fall risk factors in people with Multiple Sclerosis, run by Karolinska Institutet at 2 sites in Sweden.
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 0 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Fall Prevention Strategy Survey (time frame: Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317716, which also lists 4 linked publications.
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 27 Mar 2026.