Multiple SclerosisNCT06665607
Foot Muscles Training in Sclerosis
A study testing Intrinsic Mucle Training in people with Multiple Sclerosis and Muscle Weakness, run by Inés Llamas-Ramos at 1 site in Spain.
Trial summary
The study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Muscle Weakness, Training Group, Sensitivity
- What is being tested?
- Intrinsic Mucle Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2024to 15 Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0
Who cannot join
- Cognitive disturbances that could affect the performance of any of the tests or questionnaires included in the study
- Diagnosis of visual or vestibular disorders that could affect patient stability
- Change in Multiple Sclerosis-specific medication in the 2 months prior to the start of the study
- Acute relapse in the 2 months prior to the start of the study
- Traumatologic or orthopaedic disorders that could negatively affect balance.
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, 1 recruiting
- Recruiting
Universidad de Valladolid
Valladolid
Daniel García García, PhD
About this study
Official title: Effects of Intrinsic Foot Muscles Training in Improving Stability in Multiple Sclerosis Patients
The study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis
- Being tested
- Intrinsic Mucle Training
- Medical subject headings
- Multiple Sclerosis, Muscle Weakness, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic Mucle TrainingProcedure or surgery
Conventional physiotherapy treatment and the intrinisc foot muscles strengthening program for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Not described Receives: Procedure: Intrinsic Mucle Training |
| Control Group | Sham comparator | Not described Receives: Procedure: Intrinsic Mucle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four Square Step Test (FSST): dynamic stability assessment test.
The test consists of drawing a cross on the floor, delimiting 4 squares. The subject is placed in square number 1 in front of square number 2. The objective is to enter as quickly as possible into each square following the following sequence: Square number 1, 2, 3, 4, 1, 4, 4, 3, 2 and 1. It measures time.
Measured: Initial and after 8 weeks
Six Spot Step Test (SSST): test that quantitatively assesses lower limb function
The test field measured one meter (width) by five meters (length). In the middle of the width line (0.50 m), a cone was placed in the proximal and distal areas of the line (start point and finish point). On each lateral line, two cones were placed at distances of one and three meters on the left. Another two cones were placed at two and four meters on the right. The subjects were instructed to walk on alternating sides and to kick the cones, alternating between the medial and lateral sides of the same foot. The subjects were instructed to complete the test as quickly as possible, without running. It measures distance.
Measured: Initial and after 8 weeks
The Frailty and Injuries: Cooperative Studies of Intervention Tecnhiques (FICSIT-4 test): Test of static balance
Participants have to maintain four progressively difficult foot positions for 10 seconds each (side by side stance, semi-tandem stance, tanden stance, unipedal stance). It measures the ability to maintain posture without losing balance is evaluated.
Measured: 0-9 points. Initial and after 8 weeks
Activities-specific Balance Confidence scale (AsBC)
Evaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%
Measured: Initial and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Jul 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inés Llamas-Ramos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inés Llamas-Ramos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665607
- Sponsor's protocol ID
- FOOT TRAINING-SCLEROSIS
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Nov 2024
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrinsic Foot Muscles Training in Improving Stability in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06665607
- Acronym / sponsor ID
- FOOT TRAINING-SCLEROSIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Inés Llamas-RamosUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 30 Oct 2024 (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 study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Procedure: Intrinsic Mucle Training |
| Control Group | Sham comparator | Procedure: Intrinsic Mucle Training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0
Key exclusion criteria (5 listed)
- Cognitive disturbances that could affect the performance of any of the tests or questionnaires included in the study
- Diagnosis of visual or vestibular disorders that could affect patient stability
- Change in Multiple Sclerosis-specific medication in the 2 months prior to the start of the study
- Acute relapse in the 2 months prior to the start of the study
- Traumatologic or orthopaedic disorders that could negatively affect balance.
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 |
|---|---|---|
| Intrinsic Mucle TrainingConventional physiotherapy treatment and the intrinisc foot muscles strengthening program for 8 weeks. | Procedure or surgery | Control Group, Training Group |
Primary outcome
Four Square Step Test (FSST): dynamic stability assessment test.
Time frame: Initial and after 8 weeks
The test consists of drawing a cross on the floor, delimiting 4 squares. The subject is placed in square number 1 in front of square number 2. The objective is to enter as quickly as possible into each square following the following sequence: Square number 1, 2, 3, 4, 1, 4, 4, 3, 2 and 1. It measures time.
Six Spot Step Test (SSST): test that quantitatively assesses lower limb function
Time frame: Initial and after 8 weeks
The test field measured one meter (width) by five meters (length). In the middle of the width line (0.50 m), a cone was placed in the proximal and distal areas of the line (start point and finish point). On each lateral line, two cones were placed at distances of one and three meters on the left. Another two cones were placed at two and four meters on the right. The subjects were instructed to walk on alternating sides and to kick the cones, alternating between the medial and lateral sides of the same foot. The subjects were instructed to complete the test as quickly as possible, without running. It measures distance.
The Frailty and Injuries: Cooperative Studies of Intervention Tecnhiques (FICSIT-4 test): Test of static balance
Time frame: 0-9 points. Initial and after 8 weeks
Participants have to maintain four progressively difficult foot positions for 10 seconds each (side by side stance, semi-tandem stance, tanden stance, unipedal stance). It measures the ability to maintain posture without losing balance is evaluated.
Activities-specific Balance Confidence scale (AsBC)
Time frame: Initial and after 8 weeks
Evaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%
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 1 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrinsic Mucle Training in people with Multiple Sclerosis and Muscle Weakness, run by Inés Llamas-Ramos 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 1 inclusion and 5 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 1 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
Contact Daniel García García, PhD (620712485, daniel.ggarcia@uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four Square Step Test (FSST): dynamic stability assessment test. (time frame: Initial and after 8 weeks). The study lists 4 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 1 Nov 2024.