Multiple SclerosisCoreDISTpNCT05057338
Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
A study testing CoreDISTparticipation in people with Multiple Sclerosis, run by Nordlandssykehuset HF at 2 sites in Norway.
Trial summary
Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- CoreDISTparticipation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNorway
- Study dates
- 27 Aug 2021to 30 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 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment.
Who cannot join
- Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Bodø Municipality
Bodø
Physiotherapy department, Nordlandssykehuset HF
Bodø
About this study
Official title: Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.
Read the detailed description
The study addresses core elements in the health services for individuals with MS, constituting approximately 11000 in Norway. The two-armed pilot feasibility-RCT will be performed across the MS-outpatient (MS-OP) clinic, Nordland Hospital Trust, Bodø (NLSH), and in two surrounding municipalities, including 30 employed participants who will be followed for 10-weeks. The new intervention and pathway, CoreDISTparticipation, builds on GroupCoreDIST, which is previously found effective short and long term compared to standard care. CoreDISTparticipation consists of three phases: a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST for 60 minutes, 2 times per week supplemented with home exercise programs focusing on balance, walking and physical activity. The participants will have access to exercise programs on videos through an open website at Nord University to digitally support home training.
To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist (who leads the group trainings) will take place in phase b; followed by phase c) which include four weeks of outdoor group based exercises and physical activity led by a physiotherapist, for 60 minutes, 2 times per week supplemented with the same home exercise programs as in phase b.
Evaluation of employment and physical activity will be conducted using an evaluation form.
The control group will receive usual consultations at the MS-OP clinic, as well as a session with a physiotherapist at the MS-OP clinic, exploring possibilities for change in balance and walking. In the municipality the control group will follow standard care (their usual follow-up).
The research team will examine feasibility, preliminary between-group differences regarding balance, walking, physical activity level, health related quality of life and barriers in employment, as well as the users' experiences with participation in the CoreDISTparticipation.
- Conditions
- Multiple Sclerosis
- Being tested
- CoreDISTparticipation, Standard care
- Keywords
- Multiple sclerosis, Physiotherapy, neurology, MS nurse, coordination of care, balance, walking, physical activity, employment
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreDISTparticipationBehavioural
CoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS.
Standard careBehavioural
The standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered.
| Study group | Role | What they receive |
|---|---|---|
| CoreDISTparticipation | Experimental | a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST focusing on balance, walking and physical activity and conducted in groups of 3-5 individuals with MS and led by a physiotherapist.
To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist will take place; followed by c) four weeks of outdoor group based exercises and physical activity led by a physiotherapist, complemented with an evaluation form regarding employment and physical activity. Receives: Behavioral: CoreDISTparticipation |
| Standard care | Active comparator | The control group will receive the usual consultations at the MS-OP clinic including exploration of possibilities for change in balance and walking together with physiotherapist at the MS-OP clinic. The control group will furthermore follow standard care (their usual follow-up) in the municipality. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Measured: Baseline
Six-Minutes Walk Test
Walking distance within six minutes
Measured: Baseline
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Measured: 5 weeks post-test
Six-Minutes Walk Test
Walking distance within six minutes
Measured: 5 weeks post-test
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Measured: 10 week post-test
Six-Minutes Walk Test
Walking distance within six minutes
Measured: 10 week post-test
Secondary outcomes (37)
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Measured: Baseline
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Measured: Baseline
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Measured: Baseline
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Measured: Baseline
Activity monitors outcome 2
The monitors measure number of steps within 7 days
Measured: Baseline
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.
Measured: Baseline
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Measured: Baseline
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Measured: baseline
Weight
Self reported weight by kilogram
Measured: baseline
Height
Self reported height by centimetre
Measured: baseline
age
Self reported age by years
Measured: baseline
Social status
Self reported social status; married, cohabitant, living alone
Measured: baseline
Type of multiple sclerosis
Self reported main types: relapsing remitting, primary progressive, secondary progressive
Measured: baseline
Year of diagnosis multiple sclerosis
Self reported by year
Measured: baseline
Medications
Self reported by type of medications
Measured: baseline
Expanded disability status scale
Self reported or from journal functional status at last yearly control by a neurologist
Measured: baseline
Occupation
Self reported
Measured: baseline
Percentage of work
Self reported percentage of work the previous month
Measured: baseline
Length of education
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
Measured: baseline
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Measured: 5 weeks post-test
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Measured: 5 weeks post-test
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Measured: 5 weeks post-test
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Measured: 5 weeks post-test
Activity monitors outcome 2
The monitors measure number of steps within 7 days
Measured: 5 weeks post-test
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding
Measured: 5 weeks post-test
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Measured: 5 weeks post-test
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Measured: 5 weeks post-test
Percentage of work
Self reported percentage of work
Measured: 5 weeks post-test
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Measured: 10 weeks post-test
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Measured: 10 weeks post-test
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Measured: 10 weeks post-test
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Measured: 10 weeks post-test
Activity monitors outcome 2
The monitors measure number of steps within 7 days
Measured: 10 weeks post-test
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding
Measured: 10 weeks post-test
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Measured: 10 weeks post-test
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Measured: 10 weeks post-test
Percentage of work
Self reported percentage of work
Measured: 10 weeks post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start27 Aug 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- RCT with two arms: intervention group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- Nord University, Hasselt University, Helse Nord
- Responsible party
- Sponsor
- Investigators
- Petter Oien, PhD, Study director, Nordlandssykehuset HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057338
- Sponsor's protocol ID
- CoreDISTparticipation
- Acronym
- CoreDISTp
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arntzen EC, Braaten T, Fikke HK, Normann B. Feasibility of a new intervention addressing group-based balance and high-intensity training, physical activity, and employment in individuals with multiple sclerosis: a pilot randomized controlled trial. Front Rehabil Sci. 2024 Jan 8;4:1258737. doi: 10.3389/fresc.2023.1258737. eCollection 2023.
PubMed 38259873
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05057338
- Acronym / sponsor ID
- CoreDISTp / CoreDISTparticipation
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Physiotherapy, neurology, MS nurse, coordination of care, balance, walking, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- Nord University, Hasselt University, Helse Nord
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 27 Sep 2021 (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.
Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.
Detailed description
The study addresses core elements in the health services for individuals with MS, constituting approximately 11000 in Norway. The two-armed pilot feasibility-RCT will be performed across the MS-outpatient (MS-OP) clinic, Nordland Hospital Trust, Bodø (NLSH), and in two surrounding municipalities, including 30 employed participants who will be followed for 10-weeks. The new intervention and pathway, CoreDISTparticipation, builds on GroupCoreDIST, which is previously found effective short and long term compared to standard care. CoreDISTparticipation consists of three phases: a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST for 60 minutes, 2 times per week supplemented with home exercise programs focusing on balance, walking and physical activity. The participants will have access to exercise programs on videos through an open website at Nord University to digitally support home training.
To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist (who leads the group trainings) will take place in phase b; followed by phase c) which include four weeks of outdoor group based exercises and physical activity led by a physiotherapist, for 60 minutes, 2 times per week supplemented with the same home exercise programs as in phase b.
Evaluation of employment and physical activity will be conducted using an evaluation form.
The control group will receive usual consultations at the MS-OP clinic, as well as a session with a physiotherapist at the MS-OP clinic, exploring possibilities for change in balance and walking. In the municipality the control group will follow standard care (their usual follow-up).
The research team will examine feasibility, preliminary between-group differences regarding balance, walking, physical activity level, health related quality of life and barriers in employment, as well as the users' experiences with participation in the CoreDISTparticipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT with two arms: intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| CoreDISTparticipation | Experimental | Behavioral: CoreDISTparticipationa) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST focusing on balance, walking and physical activity and conducted in groups of 3-5 individuals with MS and led by a physiotherapist. To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist will take place; followed by c) four weeks of outdoor group based exercises and physical activity led by a physiotherapist, complemented with an evaluation form regarding employment and physical activity. |
| Standard care | Active comparator | Behavioral: Standard careThe control group will receive the usual consultations at the MS-OP clinic including exploration of possibilities for change in balance and walking together with physiotherapist at the MS-OP clinic. The control group will furthermore follow standard care (their usual follow-up) in the municipality. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment.
Key exclusion criteria (1 listed)
- Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.
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 |
|---|---|---|
| CoreDISTparticipationCoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS. | Behavioural | CoreDISTparticipation |
| Standard careThe standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered. | Behavioural | Standard care |
Primary outcome
MS Work Difficulties Questionnaire-23
Time frame: Baseline
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Six-Minutes Walk Test
Time frame: Baseline
Walking distance within six minutes
MS Work Difficulties Questionnaire-23
Time frame: 5 weeks post-test
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Six-Minutes Walk Test
Time frame: 5 weeks post-test
Walking distance within six minutes
MS Work Difficulties Questionnaire-23
Time frame: 10 week post-test
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Six-Minutes Walk Test
Time frame: 10 week post-test
Walking distance within six minutes
37 secondary outcomes
Trunk Impairment Scale Norwegian Version
Time frame: Baseline
Mini Balance Evaluation Systems Test
Time frame: Baseline
Force Platform
Time frame: Baseline
Activity monitors outcome 1
Time frame: Baseline
Activity monitors outcome 2
Time frame: Baseline
European Quality of Life 5-Dimension-3 Level
Time frame: Baseline
Multiple Sclerosis Walking Scale-12
Time frame: Baseline
Multiple Sclerosis Impact Scale-29
Time frame: baseline
Weight
Time frame: baseline
Height
Time frame: baseline
age
Time frame: baseline
Social status
Time frame: baseline
Type of multiple sclerosis
Time frame: baseline
Year of diagnosis multiple sclerosis
Time frame: baseline
Medications
Time frame: baseline
Expanded disability status scale
Time frame: baseline
Occupation
Time frame: baseline
Percentage of work
Time frame: baseline
Length of education
Time frame: baseline
Trunk Impairment Scale Norwegian Version
Time frame: 5 weeks post-test
Mini Balance Evaluation Systems Test
Time frame: 5 weeks post-test
Force Platform
Time frame: 5 weeks post-test
Activity monitors outcome 1
Time frame: 5 weeks post-test
Activity monitors outcome 2
Time frame: 5 weeks post-test
European Quality of Life 5-Dimension-3 Level
Time frame: 5 weeks post-test
Multiple Sclerosis Walking Scale-12
Time frame: 5 weeks post-test
Multiple Sclerosis Impact Scale-29
Time frame: 5 weeks post-test
Percentage of work
Time frame: 5 weeks post-test
Trunk Impairment Scale Norwegian Version
Time frame: 10 weeks post-test
Mini Balance Evaluation Systems Test
Time frame: 10 weeks post-test
Force Platform
Time frame: 10 weeks post-test
Activity monitors outcome 1
Time frame: 10 weeks post-test
Activity monitors outcome 2
Time frame: 10 weeks post-test
European Quality of Life 5-Dimension-3 Level
Time frame: 10 weeks post-test
Multiple Sclerosis Walking Scale-12
Time frame: 10 weeks post-test
Multiple Sclerosis Impact Scale-29
Time frame: 10 weeks post-test
Percentage of work
Time frame: 10 weeks post-test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 38259873Arntzen EC, Braaten T, Fikke HK, Normann B. Feasibility of a new intervention addressing group-based balance and high-intensity training, physical activity, and employment in individuals with multiple sclerosis: a pilot randomized controlled trial. Front Rehabil Sci. 2024 Jan 8;4:1258737. doi: 10.3389/fresc.2023.1258737. eCollection 2023.
- 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.
Petter Oien, PhD study director
Nordlandssykehuset HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoreDISTparticipation in people with Multiple Sclerosis, run by Nordlandssykehuset HF at 2 sites in Norway.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Sep 2021. 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 Norway. 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?
Results are not available in the source record.
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?
MS Work Difficulties Questionnaire-23 (time frame: Baseline). The study lists 6 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 NCT05057338, which also lists 1 linked publication.
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 Sep 2021.