Multiple SclerosisPhase 2MS_Early_RehabNCT06956326
Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation
A Phase 2 study testing Intensive rehab in people with Multiple Sclerosis, run by Lars Hvid at 2 sites in Denmark.
Trial summary
The overall purpose of this project is to develop and test an infrastructure that can ensure early and specialized rehabilitation for individuals with multiple sclerosis (MS) on their path to recovery from a relapse. 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?
- Intensive rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- admitted to the Danish MS Hospitals for an inpatient rehabilitation stay
- confirmed motor relapse (within the past 6 months) by a neurologist, with disability/ functional interference characterized by change in pyramidal, and/or cerebellar functional scores of 2 or higher
- completed steroid or other acute relapse treatment, if prescribed
- age over 18 years
Who cannot join
- more than 6 months since onset of motor relapse
- medical conditions or substantial cognitive impairments that hinder participation in the study (e.g. inability to perform or understand the intensive rehabilitation)
- pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
The Danish MS Hospitals
Haslev, 7080
Lars Hvid, PhD, +4593508717, larshv@sclerosehospital.dk
- Recruiting
The Danish MS Hospitals
Ry, 7080
Lars Hvid, PhD, +4593508717, larshv@sclerosehospital.dk
About this study
The overall purpose of this project is to develop and test an infrastructure that can ensure early and specialized rehabilitation for individuals with multiple sclerosis (MS) on their path to recovery from a relapse. If this project proves successful, it can therefore help optimize clinical practice and provide a significant contribution to the treatment of relapsing-remitting sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Intensive rehab, Usual care
- Keywords
- Neurorehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive rehabBehavioural
Frequent moderate-to-high intensity physical therapy, provided by local physiotherapists.
Usual careBehavioural
Usual care physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intensive rehab | Experimental | 10 weeks of community-based physical therapy. Participants will receive two weekly supervised physical therapy session (45-60 minutes).
The content of this exercise program and the specific exercises and exercise methods will be planned in collaboration between MS specialists from the Danish MS hospitals, the local physical therapist, and the participant. Receives: Behavioral: Intensive rehab |
| Usual care | Active comparator | 10 weeks of usual care physiotherapy, normally comprised of municipal rehabilitation as well as self-administered behavior. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale measures your current level of disability.
Measured: Change from Baseline to 52 weeks
MS Functional Composite (MSFC) Score
A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).
Measured: Change from Baseline to 52 weeks
Secondary outcomes (13)
MS Functional Composite (MSFC) Score
A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).
Measured: Changes from Baseline to 2 weeks and 10 weeks
Handgrip strength
Maximal handgrip muscle strength of both sides.
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Six spot step test (SSST)
Measure of walking balance and coordination
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Five times sit to stand chair rise test (5STS)
Measure of lower extremity function
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Five times sit to stand chair rise test muscle power (5STS_power)
Measure of lower extremity muscle power
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Patient determined disease steps (PDDS)
Patient-reported measure of mobility disability.
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
MS Walking Scale (MSWS)
Patient-reported measure of walking ability.
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Falls Efficacy Scale International (short FES-I)
Patient-reported measure of concerns of falls (including history of falls).
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Functional Assessment of MS (FAMS)
Patient-reported measure of how MS impacts quality of life.
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Modified Fatigue Impact Scale (MFIS)
Patient-reported measure of fatigue.
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Manual Ability Measurement (MAM36)
Patient-reported measure of hand function related to functional questions.
Measured: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Treatment Satisfactory Questionnaire (TSQ)
Patient-reported measure of treatment satisfaction.
Measured: Evaluated at 2 weeks, 10 weeks, and 52 weeks
Multiple Sclerosis Cognitive Scale (MSCS)
Patient-reported measure of cognitive function.
Measured: Changes from baseline to 2 weeks, 10 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Hvid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Hvid, Danish Multiple Sclerosis Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956326
- Sponsor's protocol ID
- MS_Early_Rehab
- Acronym
- MS_Early_Rehab
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 4 May 2025
- 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 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation
- ClinicalTrials.gov ID
- NCT06956326
- Acronym / sponsor ID
- MS_Early_Rehab / MS_Early_Rehab
- Conditions
- Multiple Sclerosis
- Keywords
- Neurorehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Lars HvidUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 2025 (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.
The overall purpose of this project is to develop and test an infrastructure that can ensure early and specialized rehabilitation for individuals with multiple sclerosis (MS) on their path to recovery from a relapse. If this project proves successful, it can therefore help optimize clinical practice and provide a significant contribution to the treatment of relapsing-remitting sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive rehab | Experimental | Behavioral: Intensive rehab10 weeks of community-based physical therapy. Participants will receive two weekly supervised physical therapy session (45-60 minutes). The content of this exercise program and the specific exercises and exercise methods will be planned in collaboration between MS specialists from the Danish MS hospitals, the local physical therapist, and the participant. |
| Usual care | Active comparator | Behavioral: Usual care10 weeks of usual care physiotherapy, normally comprised of municipal rehabilitation as well as self-administered behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to the Danish MS Hospitals for an inpatient rehabilitation stay
- confirmed motor relapse (within the past 6 months) by a neurologist, with disability/ functional interference characterized by change in pyramidal, and/or cerebellar functional scores of 2 or higher
- completed steroid or other acute relapse treatment, if prescribed
- age over 18 years
Key exclusion criteria (3 listed)
- more than 6 months since onset of motor relapse
- medical conditions or substantial cognitive impairments that hinder participation in the study (e.g. inability to perform or understand the intensive rehabilitation)
- pregnancy
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 |
|---|---|---|
| Intensive rehabFrequent moderate-to-high intensity physical therapy, provided by local physiotherapists. | Behavioural | Intensive rehab |
| Usual careUsual care physiotherapy | Behavioural | Usual care |
Primary outcome
Expanded Disability Status Scale (EDSS)
Time frame: Change from Baseline to 52 weeks
The Expanded Disability Status Scale measures your current level of disability.
MS Functional Composite (MSFC) Score
Time frame: Change from Baseline to 52 weeks
A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).
13 secondary outcomes
MS Functional Composite (MSFC) Score
Time frame: Changes from Baseline to 2 weeks and 10 weeks
Handgrip strength
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Six spot step test (SSST)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Five times sit to stand chair rise test (5STS)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Five times sit to stand chair rise test muscle power (5STS_power)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Patient determined disease steps (PDDS)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
MS Walking Scale (MSWS)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Falls Efficacy Scale International (short FES-I)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Functional Assessment of MS (FAMS)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Modified Fatigue Impact Scale (MFIS)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Manual Ability Measurement (MAM36)
Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Treatment Satisfactory Questionnaire (TSQ)
Time frame: Evaluated at 2 weeks, 10 weeks, and 52 weeks
Multiple Sclerosis Cognitive Scale (MSCS)
Time frame: Changes from baseline to 2 weeks, 10 weeks, and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensive rehab in people with Multiple Sclerosis, run by Lars Hvid at 2 sites in Denmark.
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 4 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Hvid, PhD (+4593508717, larshv@sclerosehospital.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale (EDSS) (time frame: Change from Baseline to 52 weeks). 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?
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 4 May 2025.