Multiple SclerosisSensorimotorMSNCT07735325
Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.
A study testing Sensorimotor insoles in people with Multiple Sclerosis, run by University of Salamanca at 1 site in Spain.
Trial summary
This single-blind, randomized controlled clinical trial aims to evaluate the long-term effects of using sensorimotor insoles (SMIs) on stability and gait capacity in individuals diagnosed with multiple sclerosis (MS). 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?
- Sensorimotor insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2026to Jan 2027
- 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
- Medical diagnosis of multiple sclerosis (MS), including relapsing-remitting, primary progressive, or secondary progressive subtypes.
- Age > 18 years.
- Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0 (ranging from minimal disability to requiring a cane to walk).
- Signed written informed consent.
Who cannot join
- Cognitive impairment.
- Visual or vestibular disorders that could impair stability.
- Changes in disease-specific medication within the 2 months prior to study baseline.
- MS relapse within the 2 months prior to study baseline (for relapsing-remitting MS cases).
- Lower-limb capsuloligamentous injury within the 2 months prior to study baseline (such as ankle or knee sprains) that could affect stability or gait pattern.
Trial locations and contacts
1 site in 1 country.
About this study
This single-blind, randomized controlled clinical trial aims to evaluate the long-term effects of using sensorimotor insoles (SMIs) on stability and gait capacity in individuals diagnosed with multiple sclerosis (MS). Secondary objectives include assessing the impact of SMIs on plantar cutaneous sensitivity, ankle muscle strength, quality of life, and overall functional status in this patient population.The study sample comprises 50 adult participants diagnosed with MS (including relapsing-remitting, primary progressive, and secondary progressive subtypes) with Expanded Disability Status Scale (EDSS) scores ranging from 2.0 to 6.0. Participants will be randomly allocated into an experimental group ($n = 25$) and a control group ($n = 25$). The experimental group will receive custom "Anatomy Line" SMIs (Springer Aktiv GmbH), fabricated using 3D digital foot models generated via the Foot Scan 3D mobile application. The intervention spans seven months, beginning with a one-month progressive adaptation period before transitioning to daily, full-day use within habitual footwear. The control group will receive no study-specific intervention, and participants in both groups will maintain their conventional physical therapy regimens throughout the study.All outcome measures will be evaluated at baseline and immediately following the 7-month intervention period by research team members who are blinded to group allocation. Primary outcomes include stability, evaluated using the Berg Balance Scale (BBS), and gait capacity, assessed via the Gait Assessment and Intervention Tool (GAIT). Secondary outcomes include plantar cutaneous sensitivity evaluated at three plantar sites using Semmes-Weinstein monofilaments, ankle muscle strength measured across four movement planes using an Activforce 2 digital handheld dynamometer, and health-related quality of life and functional status assessed through the 52-item Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
Read the detailed description
This study is a single-blind, randomized controlled clinical trial designed to evaluate the long-term physiological and functional effects of sensorimotor insoles (SMIs) in individuals diagnosed with Multiple Sclerosis (MS).
Intervention Protocol and Device Customization Participants allocated to the experimental group receive custom-fabricated SMIs (Anatomy Line model, Springer Aktiv GmbH, Berlin, Germany). Digital foot models are generated using a mobile application (Foot Scan 3D) coupled with a specialized phone mirror device to capture three-dimensional foot morphology for custom orthosis manufacturing.
To ensure patient safety, promote acclimatization, and minimize potential adverse events, a structured 1-month adaptation protocol is implemented:
Adaptation Phase (Month 1): Participants wear the SMIs starting at 1 hour per day, increasing wear time by 1 hour every 3 days. SMI usage is initially restricted to indoor activities before expanding to outdoor use.
Maintenance Phase (Months 2-7): Following adaptation, participants wear the custom SMIs continuously during all daily activities within their habitual footwear.
The control group receives no study-specific insole intervention. To control for confounding rehabilitation effects, participants in both the experimental and control groups maintain their conventional, ongoing physical therapy regimens throughout the 7-month study period.
Evaluator Blinding and Site Logistics All outcome assessments take place at baseline and immediately following the 7-month intervention period at the facilities of the Asociación Vallisoletana de Esclerosis Múltiple. To maintain single-blind integrity, outcome evaluations are conducted by assessors who are fully masked to participant group assignment. Participant recruitment, randomization, and intervention monitoring are handled by independent research team members who do not perform outcome testing.
- Conditions
- Multiple Sclerosis
- Being tested
- Sensorimotor insoles
- Keywords
- Sensorimotor insoles, multiple sclerosis, gait, stability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor insolesDevice
Daily use of sensorimotor insoles for at least 5 hours per day over a 6-month period. The insoles will be worn during activities of daily living or sports activities and are custom-designed for each participant. At the beginning of the study, an adaptation period will be implemented during which insole wear time is progressively increased.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: use of sensorimotor insoles | Experimental | Daily use of sensorimotor insoles for at least 5 hours per day over a 6-month period. The insoles will be worn during activities of daily living or sports activities and are custom-designed for each participant. At the beginning of the study, an adaptation period will be implemented during which insole wear time is progressively increased. Receives: Device: Sensorimotor insoles |
| Comtrol group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability
Berg Balance Scale
Measured: 6 months
Secondary outcomes (4)
Gait
Gait Assessment and Intervention Tool
Measured: 6 months
Plantar cutaneous sensitivity
Pressure treshold
Measured: 6 months
Ankle strength
Manual dynamometry
Measured: 6 months
Function and Quality of life
Functional Assessment of Multiple Sclerosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel García García, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735325
- Sponsor's protocol ID
- INV2026-68
- Acronym
- SensorimotorMS
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT07735325
- Acronym / sponsor ID
- SensorimotorMS / INV2026-68
- Conditions
- Multiple Sclerosis
- Keywords
- Sensorimotor insoles, multiple sclerosis, gait, stability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Jul 2026 (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 single-blind, randomized controlled clinical trial aims to evaluate the long-term effects of using sensorimotor insoles (SMIs) on stability and gait capacity in individuals diagnosed with multiple sclerosis (MS). Secondary objectives include assessing the impact of SMIs on plantar cutaneous sensitivity, ankle muscle strength, quality of life, and overall functional status in this patient population.The study sample comprises 50 adult participants diagnosed with MS (including relapsing-remitting, primary progressive, and secondary progressive subtypes) with Expanded Disability Status Scale (EDSS) scores ranging from 2.0 to 6.0. Participants will be randomly allocated into an experimental group ($n = 25$) and a control group ($n = 25$). The experimental group will receive custom "Anatomy Line" SMIs (Springer Aktiv GmbH), fabricated using 3D digital foot models generated via the Foot Scan 3D mobile application. The intervention spans seven months, beginning with a one-month progressive adaptation period before transitioning to daily, full-day use within habitual footwear. The control group will receive no study-specific intervention, and participants in both groups will maintain their conventional physical therapy regimens throughout the study.All outcome measures will be evaluated at baseline and immediately following the 7-month intervention period by research team members who are blinded to group allocation. Primary outcomes include stability, evaluated using the Berg Balance Scale (BBS), and gait capacity, assessed via the Gait Assessment and Intervention Tool (GAIT). Secondary outcomes include plantar cutaneous sensitivity evaluated at three plantar sites using Semmes-Weinstein monofilaments, ankle muscle strength measured across four movement planes using an Activforce 2 digital handheld dynamometer, and health-related quality of life and functional status assessed through the 52-item Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
Detailed description
This study is a single-blind, randomized controlled clinical trial designed to evaluate the long-term physiological and functional effects of sensorimotor insoles (SMIs) in individuals diagnosed with Multiple Sclerosis (MS).
Intervention Protocol and Device Customization Participants allocated to the experimental group receive custom-fabricated SMIs (Anatomy Line model, Springer Aktiv GmbH, Berlin, Germany). Digital foot models are generated using a mobile application (Foot Scan 3D) coupled with a specialized phone mirror device to capture three-dimensional foot morphology for custom orthosis manufacturing.
To ensure patient safety, promote acclimatization, and minimize potential adverse events, a structured 1-month adaptation protocol is implemented:
Adaptation Phase (Month 1): Participants wear the SMIs starting at 1 hour per day, increasing wear time by 1 hour every 3 days. SMI usage is initially restricted to indoor activities before expanding to outdoor use.
Maintenance Phase (Months 2-7): Following adaptation, participants wear the custom SMIs continuously during all daily activities within their habitual footwear.
The control group receives no study-specific insole intervention. To control for confounding rehabilitation effects, participants in both the experimental and control groups maintain their conventional, ongoing physical therapy regimens throughout the 7-month study period.
Evaluator Blinding and Site Logistics All outcome assessments take place at baseline and immediately following the 7-month intervention period at the facilities of the Asociación Vallisoletana de Esclerosis Múltiple. To maintain single-blind integrity, outcome evaluations are conducted by assessors who are fully masked to participant group assignment. Participant recruitment, randomization, and intervention monitoring are handled by independent research team members who do not perform outcome testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: use of sensorimotor insoles | Experimental | Device: Sensorimotor insolesDaily use of sensorimotor insoles for at least 5 hours per day over a 6-month period. The insoles will be worn during activities of daily living or sports activities and are custom-designed for each participant. At the beginning of the study, an adaptation period will be implemented during which insole wear time is progressively increased. |
| Comtrol group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medical diagnosis of multiple sclerosis (MS), including relapsing-remitting, primary progressive, or secondary progressive subtypes.
- Age > 18 years.
- Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0 (ranging from minimal disability to requiring a cane to walk).
- Signed written informed consent.
Key exclusion criteria (5 listed)
- Cognitive impairment.
- Visual or vestibular disorders that could impair stability.
- Changes in disease-specific medication within the 2 months prior to study baseline.
- MS relapse within the 2 months prior to study baseline (for relapsing-remitting MS cases).
- Lower-limb capsuloligamentous injury within the 2 months prior to study baseline (such as ankle or knee sprains) that could affect stability or gait pattern.
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 |
|---|---|---|
| Sensorimotor insolesDaily use of sensorimotor insoles for at least 5 hours per day over a 6-month period. The insoles will be worn during activities of daily living or sports activities and are custom-designed for each participant. At the beginning of the study, an adaptation period will be implemented during which insole wear time is progressively increased. | Device | Intervention group: use of sensorimotor insoles |
Primary outcome
Stability
Time frame: 6 months
Berg Balance Scale
4 secondary outcomes
Gait
Time frame: 6 months
Plantar cutaneous sensitivity
Time frame: 6 months
Ankle strength
Time frame: 6 months
Function and Quality of life
Time frame: 6 months
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 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Sensorimotor insoles in people with Multiple Sclerosis, run by University of Salamanca 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 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. 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?
Stability (time frame: 6 months). 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 29 Jul 2026.