Multiple SclerosisPhase 2PLATINUMSNCT07310914
Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis
A Phase 2 study testing Telerehabilitation and Paper-based exercise in people with Multiple Sclerosis, run by Danish Multiple Sclerosis Hospitals at 5 sites in 4 countries.
Trial summary
The overall purpose of the present study is to investigate the effect of an advanced telerehablitation system (TRS) in persons with multiple sclerosis on mobility. The advanced telerhabilitation system is based on AI components, and delivers instant feedback to the partcipants. 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?
- Telerehabilitation and Paper-based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Feb 2026to 1 Jul 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
- Definite diagnosis of MS according to the McDonald criteria (both relapse-remitting and progressive)
- Expanded Disability Status Scale (EDSS) score of 2.5 to 6.5 or Patient Determined Disability Score (PDDS) of 2 to 6, indicating preservation of at least some ambulatory function, that is, the ability to walk 20 meters or more, independently, with or without the use of an assistive device
- Willingness to travel to the local study site for the evaluation sessions,
- Internet platform availability
Who cannot join
- comorbidities hindering participation in the study.
- Individuals who have had a documented relapse and/or corticoid treatment during the past three months will be excluded,
- Individuals with severe cognitive deficits who cannot follow simple instructions and/or consent.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Denmark2 sites
The Danish MS Hospitals, Haslev
Haslev, 4690
Lars Hvid, +4593508717, larshv@sclerosehospital.dk
The Danish MS Hospitals, Ry
Ry, 8660
Lars Hvid, Phd, +4593508717, larshv@sclerosehospital.dk
Ireland1 site
MS Ireland
Dublin
Susan Coote, +353 86 036 4109, susanc@ms-society.ie
Israel1 site
Tel Aviv University
Tel Aviv
Alon Kalron, +972 52 243 6839, alonkalron@gmail.com
Italy1 site
University of Cagliari
Cagliari
Massimiliano Pau, +39 338 782 5240, massimiliano.pau@unica.it
About this study
The overall purpose of the present study is to investigate the effect of an advanced telerehablitation system (TRS) in persons with multiple sclerosis on mobility. The advanced telerhabilitation system is based on AI components, and delivers instant feedback to the partcipants. If the project is successful, it can help optimize exercise for those persons with multiple sclerosis who are either not able or willing to travel to a clinical setting for exericse.
- Conditions
- Multiple Sclerosis
- Being tested
- Telerehabilitation, Paper-based exercise
- Keywords
- Neurorehabilitation, Telerehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
Advanced telerehabilitation with a program made by specialized physiotherapists and delivered through the WizeCare system.
Paper-based exerciseBehavioural
Paper-based exercise instructions made by specialized physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 10 weeks of home-based exercise performed with the telerehabilitation system. Partipicants will perform two sessions per week (30-45 minutes). The content of the exercise program and the specific exercises will be planned by specialized physiotherapists. Receives: Behavioral: Telerehabilitation |
| Paper-based instructions | Active comparator | 10 weeks of home-based exercise with paper-based instructions. Partipicants will perform two sessions per week (30-45 minutes). The content of the exercise program and the specific exercises will be planned by specialized physiotherapists.Paper-based exercise instructions Receives: Behavioral: Paper-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 second sit to stand test
Measure of lower extremity muscle power and a proxy measure of mobility
Measured: Baseline to 10 weeks
Secondary outcomes (15)
Short Physical Performance Battery
Meaure of balance, walking function and lower extremity muscle strength
Measured: Baseline to 10 weeks
Functional Reach Test
A measure of stability
Measured: Baseline to 10 weeks
Timed 25 feet foot walk test
A measure of walking speed
Measured: Baseline to 10 weeks
MiniBESTest
A measure of balance
Measured: Baseline to 10 weeks
Six minute walk test
A measure of walking endurance
Measured: Baseline to 10 weeks
Modified Fatigue Impact Scale
Patient-reported measure of fatigue
Measured: Baseline
12 item Multiple Sclerosis Walking Scale
Patient-reported outcome of walking function
Measured: Baseline to 10 weeks
Multiple Sclerosis Impact Scale
Patient-reported measure on the impact of multiple sclerosis
Measured: Baseline to 10 weeks
EQ-5D-5L
Patient-reported measure of quality of life
Measured: Baseline to 10 weeks
State-Trait Anxiety Inventory
Patient-reported measure of anxiety
Measured: Baseline to 10 weeks
Quick Inventory of Depression Symptomology
Patient-reported measure of depressive symptoms
Measured: Baseline to 10 weeks
Client Services Receipt Inventory
Patient-reported measure of used health services
Measured: Baseline to 10 weeks
Digital Health Literacy Scale
Patient-reported measure of digital health literacy
Measured: Baseline
Telehealth Usability Questionnaire
Patient-reported measure of telehealth usability
Measured: 10 weeks
Semi-structed interview
A semi-structured interview on the satisfaction with the telerehabilitation system
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Multiple Sclerosis Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- MS Ireland, Tel Aviv University, University of Cagliari, University of Limerick
- Responsible party
- Principal investigator, Lars Hvid, Danish Multiple Sclerosis Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310914
- Sponsor's protocol ID
- Telerehabilitation in PWMS
- Acronym
- PLATINUMS
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taul-Madsen L, Hvid LG, Casu G, Pau M, Synnott E, Coote S, Alt Y, Kalron A. Protocol for a pilot effectiveness and feasibility randomized controlled trial of an advanced telerehabilitation system for people with multiple sclerosis (PLATINUMS project). PLoS One. 2026 Aug 18;21(8):e0355376. doi: 10.1371/journal.pone.0355376. eCollection 2026.
PubMed 42611888
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07310914
- Acronym / sponsor ID
- PLATINUMS / Telerehabilitation in PWMS
- Conditions
- Multiple Sclerosis
- Keywords
- Neurorehabilitation, Telerehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Danish Multiple Sclerosis HospitalsUniversity, hospital or other
- Collaborators
- MS Ireland, Tel Aviv University, University of Cagliari, University of Limerick
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Dec 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 the present study is to investigate the effect of an advanced telerehablitation system (TRS) in persons with multiple sclerosis on mobility. The advanced telerhabilitation system is based on AI components, and delivers instant feedback to the partcipants. If the project is successful, it can help optimize exercise for those persons with multiple sclerosis who are either not able or willing to travel to a clinical setting for exericse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Telerehabilitation10 weeks of home-based exercise performed with the telerehabilitation system. Partipicants will perform two sessions per week (30-45 minutes). The content of the exercise program and the specific exercises will be planned by specialized physiotherapists. |
| Paper-based instructions | Active comparator | Behavioral: Paper-based exercise10 weeks of home-based exercise with paper-based instructions. Partipicants will perform two sessions per week (30-45 minutes). The content of the exercise program and the specific exercises will be planned by specialized physiotherapists.Paper-based exercise instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Definite diagnosis of MS according to the McDonald criteria (both relapse-remitting and progressive)
- Expanded Disability Status Scale (EDSS) score of 2.5 to 6.5 or Patient Determined Disability Score (PDDS) of 2 to 6, indicating preservation of at least some ambulatory function, that is, the ability to walk 20 meters or more, independently, with or without the use of an assistive device
- Willingness to travel to the local study site for the evaluation sessions,
- Internet platform availability
Key exclusion criteria (3 listed)
- comorbidities hindering participation in the study.
- Individuals who have had a documented relapse and/or corticoid treatment during the past three months will be excluded,
- Individuals with severe cognitive deficits who cannot follow simple instructions and/or consent.
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 |
|---|---|---|
| TelerehabilitationAdvanced telerehabilitation with a program made by specialized physiotherapists and delivered through the WizeCare system. | Behavioural | Experimental |
| Paper-based exercisePaper-based exercise instructions made by specialized physiotherapists. | Behavioural | Paper-based instructions |
Primary outcome
30 second sit to stand test
Time frame: Baseline to 10 weeks
Measure of lower extremity muscle power and a proxy measure of mobility
15 secondary outcomes
Short Physical Performance Battery
Time frame: Baseline to 10 weeks
Functional Reach Test
Time frame: Baseline to 10 weeks
Timed 25 feet foot walk test
Time frame: Baseline to 10 weeks
MiniBESTest
Time frame: Baseline to 10 weeks
Six minute walk test
Time frame: Baseline to 10 weeks
Modified Fatigue Impact Scale
Time frame: Baseline
12 item Multiple Sclerosis Walking Scale
Time frame: Baseline to 10 weeks
Multiple Sclerosis Impact Scale
Time frame: Baseline to 10 weeks
EQ-5D-5L
Time frame: Baseline to 10 weeks
State-Trait Anxiety Inventory
Time frame: Baseline to 10 weeks
Quick Inventory of Depression Symptomology
Time frame: Baseline to 10 weeks
Client Services Receipt Inventory
Time frame: Baseline to 10 weeks
Digital Health Literacy Scale
Time frame: Baseline
Telehealth Usability Questionnaire
Time frame: 10 weeks
Semi-structed interview
Time frame: 10 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 30 Dec 2025.
- Derived from this study: PubMed 42611888Taul-Madsen L, Hvid LG, Casu G, Pau M, Synnott E, Coote S, Alt Y, Kalron A. Protocol for a pilot effectiveness and feasibility randomized controlled trial of an advanced telerehabilitation system for people with multiple sclerosis (PLATINUMS project). PLoS One. 2026 Aug 18;21(8):e0355376. doi: 10.1371/journal.pone.0355376. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telerehabilitation and Paper-based exercise in people with Multiple Sclerosis, run by Danish Multiple Sclerosis Hospitals at 5 sites in 4 countries.
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: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Ireland, Israel, Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 second sit to stand test (time frame: Baseline to 10 weeks). 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 NCT07310914, 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 30 Dec 2025.