Multiple SclerosisNCT07106255
Task-oriented Training Intervention for Multiple Sclerosis Patients.
A study testing Task-oriented training and Standar medical care and leaflet fatigue management in people with Multiple Sclerosis, run by Universidad de Granada at 1 site in Spain.
Trial summary
This study aims to evaluate the effectiveness of a Task-oriented program in improving functional performance and health outcomes in patients with Multiple Sclerosis. 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?
- Task-oriented training and Standar medical care and leaflet fatigue management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- 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
- Diagnosis of Multiple Sclerosis by a neurologist.
- Aged over 18 years old.
- Acceptance and signature of the informed consent.
Who cannot join
- A cognitive level or condition that did not allow completion of the evaluations.
- An exacerbation of MS during the previous 3 months.
- Presence of interfering musculoskeletal, neurological, orthopaedic, and/or rheumatic disorders affecting hand and/or finger mobility, including previous trauma or fracture of the upper extremity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of Health Sciences. University of Granada
Granada, Granada, 18071
About this study
Official title: Task-oriented Training Intervention for Multiple Sclerosis Patients
This study aims to evaluate the effectiveness of a Task-oriented program in improving functional performance and health outcomes in patients with Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Task-oriented training, Standar medical care and leaflet fatigue management
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented trainingOther
Participants included in the experimental group will underwent an 8-week TOT intervention, administered twice weekly, with each session lasting 45 minutes.
Within this framework, the intervention will comprise sessions involving meaningful and repetitive activities tailored to both the patient and their specific context. The occupations will be selected by each participant through the Canadian Occupational Performance Measure (COMP) tool in the initial assessment. The activities were randomly ordered and focused on the reconstruction of complete tasks. To support task segmentation, a range of custom-designed materials will be employed, alongside therapeutic tools and materials such as therapeutic putty, TheraBand, and others commonly used in physical rehabilitation interventions. Throughout the intervention, participants will receive positive reinforcement that will fade over the time to prevent unnecessary dependency.
Standar medical care and leaflet fatigue managementOther
Participants included in the control group will continue with their usual treatment and will receive a pamphlet containing information on fatigue management.
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented training program | Experimental | Task-oriented training program Receives: Other: Task-oriented training |
| Standard medical care and leaflet fatigue management | Active comparator | Not described Receives: Other: Standar medical care and leaflet fatigue management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Performance
The main variable in this study will be the Canadian Occupational Performance Measure (COPM). This tool measures the perception of problems related to the overall quality of performance, development and satisfaction with particular occupations.
Measured: Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)
Secondary outcomes (1)
Fatigue
The level of fatigue will be assessed with the Modified Impact Fatigue Scale (MFIS) and the Fatigue Severity Scale (FSS). The MFIS consists of items from which a total score is obtained and for each subscale. Scores range from 0 to 36 with higher scores indicating a greater impact of fatigue on activities. The FSS consists of 9 items that are rated on a scale of 1 to 7. A higher score indicates a higher agreement with the statement presented in each item.
Measured: Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106255
- Sponsor's protocol ID
- 036-N-23
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Training Intervention for Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07106255
- Acronym / sponsor ID
- 036-N-23
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Aug 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.
This study aims to evaluate the effectiveness of a Task-oriented program in improving functional performance and health outcomes in patients with Multiple Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented training program | Experimental | Other: Task-oriented trainingTask-oriented training program |
| Standard medical care and leaflet fatigue management | Active comparator | Other: Standar medical care and leaflet fatigue management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Multiple Sclerosis by a neurologist.
- Aged over 18 years old.
- Acceptance and signature of the informed consent.
Key exclusion criteria (3 listed)
- A cognitive level or condition that did not allow completion of the evaluations.
- An exacerbation of MS during the previous 3 months.
- Presence of interfering musculoskeletal, neurological, orthopaedic, and/or rheumatic disorders affecting hand and/or finger mobility, including previous trauma or fracture of the upper extremity.
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 |
|---|---|---|
| Task-oriented trainingParticipants included in the experimental group will underwent an 8-week TOT intervention, administered twice weekly, with each session lasting 45 minutes. Within this framework, the intervention will comprise sessions involving meaningful and repetitive activities tailored to both the patient and their specific context. The occupations will be selected by each participant through the Canadian Occupational Performance Measure (COMP) tool in the initial assessment. The activities were randomly ordered and focused on the reconstruction of complete tasks. To support task segmentation, a range of custom-designed materials will be employed, alongside therapeutic tools and materials such as therapeutic putty, TheraBand, and others commonly used in physical rehabilitation interventions. Throughout the intervention, participants will receive positive reinforcement that will fade over the time to prevent unnecessary dependency. | Other | Task-oriented training program |
| Standar medical care and leaflet fatigue managementParticipants included in the control group will continue with their usual treatment and will receive a pamphlet containing information on fatigue management. | Other | Standard medical care and leaflet fatigue management |
Primary outcome
Occupational Performance
Time frame: Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)
The main variable in this study will be the Canadian Occupational Performance Measure (COPM). This tool measures the perception of problems related to the overall quality of performance, development and satisfaction with particular occupations.
1 secondary outcome
Fatigue
Time frame: Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)
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 6 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented training and Standar medical care and leaflet fatigue management in people with Multiple Sclerosis, run by Universidad de Granada at 1 site in Spain.
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 3 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2025. 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 Spain. 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?
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?
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?
Occupational Performance (time frame: Baseline and at 8 weeks at the end of the intervention, and through study completion, at 1, 3, 6, and 12 months post-intervention (an average of 1 year)). 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 6 Aug 2025.