Multiple SclerosisETOTURNCT07847853
Inductive Therapeutic Exercise in Multiple Sclerosis
A study testing Experimental: Inductive Therapeutic Exercise (ETI) in people with Multiple Sclerosis, run by Fundación San Juan De Dios at 2 sites in Spain.
Trial summary
ETOTUR is a research project comprising two complementary stages. The first is an observational study in approximately 50 healthy adults to develop and validate a mobile tool for quantitative assessment of muscle tone using the pendulum test. 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?
- Experimental: Inductive Therapeutic Exercise (ETI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2027to Jul 2028
- 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
- Confirmed medical diagnosis of multiple sclerosis.
- Age 18 years or older.
- Ability to understand and follow the instructions required for the study procedures.
- Altered lower-limb muscle tone, demonstrated by pendulum test measurements outside the reference ranges established in the preparatory study and/or normative values reported in the scientific literature.
- Impaired standing postural control, demonstrated by stabilometric parameters consistent with reduced postural stability, such as increased center of pressure displacement, increased mean sway velocity, or increased sway area.
- Provision of written informed consent.
Who cannot join
- Other neurological, neurodegenerative, or musculoskeletal conditions that may interfere with biomechanical or functional assessments.
- Receipt of inductive therapies, neuromodulatory treatments, or specific interventions targeting muscle tone during the previous 6 months.
- Insufficient understanding of Spanish or inability to follow the study instructions.
- Medical contraindication to the proposed interventions or assessments.
- An acute multiple sclerosis exacerbation or clinical relapse in the months preceding study entry, as determined by medical judgment.
- Pregnancy.
- Uncontrolled arterial hypertension or ocular hypertension.
- Inability to maintain sitting or standing for the duration required to complete the biomechanical assessments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Escuela Universitaria de Enfermería y Fisioterapia San Juan de Dios - Universidad Pontificia Comillas
Madrid, Madrid, 28016
Carlos J Carpintero Rubio, PT, PhD, +34 637829951, ccarpintero@comillas.edu
Gema M Escobar Aguilar, RN, PhD, +34 915641868 ext. 3266, gemaescobar@comillas.edu
Hospital Universitario San Rafael
Madrid, Madrid, 28016
Carlos J Carpintero Rubio, PT, PhD, +34 637829951, ccarpintero@comillas.edu
Gema M Escobar Aguilar, RN, PhD, +34 915641868 ext. 3266, gemaescobar@comillas.edu
About this study
Official title: Effects of Inductive Therapeutic Exercise on Muscle Tone, Postural Control, and Quality of Life in Patients With Multiple Sclerosis.
ETOTUR is a research project comprising two complementary stages. The first is an observational study in approximately 50 healthy adults to develop and validate a mobile tool for quantitative assessment of muscle tone using the pendulum test. Measurements obtained with the mobile tool will be compared with laboratory reference systems, and preliminary reference values will be established.
The second stage, which is the focus of this clinical trial registration, is a pilot controlled study involving approximately 30 adults with multiple sclerosis and altered muscle tone and standing postural control. Participants will receive either Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") or Sham Inductive Therapeutic Exercise (sham-ETI), a simulated intervention, with one individual session of approximately 40 minutes per week for 8 weeks.
Read more
ETI combines specific active movements and breathing patterns intended to elicit involuntary neuromuscular responses in other body regions. Sham-ETI uses similar movements while omitting the principal movement and breathing components intended to produce induction.
Participants will be assigned using a nonrandom sequential balancing procedure based on relevant baseline characteristics. Outcome assessment will be performed by a physiotherapist blinded to group allocation.
Outcomes will be assessed at baseline, immediately after the 8-week intervention, and approximately one month later. The main outcomes are lower-limb muscle tone assessed using the pendulum test, standing postural control measured with a pressure platform, and health-related quality of life assessed with the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54). Adherence, tolerability, and intervention-related clinical incidents will also be recorded.
The study will explore whether changes following ETI differ from those observed after sham-ETI and will provide preliminary information to support the design of subsequent confirmatory research.
Read the detailed description
Scientific rationale.
ETOTUR combines the development of an accessible biomechanical assessment tool with an exploratory investigation of Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") in multiple sclerosis. The project addresses two related research needs: obtaining reproducible quantitative measurements of limb pendular behavior and investigating whether an intervention intended to elicit involuntary neuromuscular responses can influence muscle tone, postural control, and health-related quality of life.
The rationale for the measurement component is to complement clinical assessment with instrumented recordings that can be obtained using portable technology. The pendulum test characterizes the movement of a relaxed limb after release, including its initial excursion and subsequent oscillations. ETOTUR will investigate whether a mobile tool can capture these features consistently and with sufficient agreement with laboratory reference systems to support its intended research use.
The therapeutic component investigates ETI as an approach combining specific active movements, positioning, and breathing patterns to elicit neuromuscular responses beyond the body region performing the voluntary movement. The working hypothesis is that these responses may influence tonic and postural regulation. This proposed mechanism provides the rationale for the intervention but is not considered established, and the clinical study is not designed to demonstrate the underlying neurophysiological mechanism directly.
Relationship between the two studies.
The project comprises two sequential studies with distinct populations and objectives. Study 1 is an observational, cross-sectional measurement-validation study in healthy adults. Study 2 is a pilot, nonrandomized, controlled intervention study in adults with multiple sclerosis.
The methodological study will inform the subsequent clinical use of the measurement tool. The healthy participants will provide measurement-validation data and preliminary reference values; they will not constitute a treatment comparison group for participants with multiple sclerosis. Analyses will be conducted separately for each study.
The clinical intervention study is the focus of this trial registration. The preparatory validation study is described here to explain the development of the assessment approach and its role within the wider ETOTUR project.
Study 1: development and measurement validation.
The first study will develop and evaluate a mobile assessment system for upper- and lower-limb pendulum testing, incorporating portable inertial sensing. Measurements will be compared with laboratory reference recordings obtained using three-dimensional optical motion capture and high-precision triaxial accelerometry, as appropriate to the measurement being evaluated.
Standardized positioning, calibration, synchronization, and limb-release procedures will be used to reduce avoidable variation. Repeated recordings will allow assessment of measurement consistency under the study conditions.
The analysis will distinguish reliability from agreement between systems. Intraclass correlation coefficients will characterize reliability, while agreement analyses, including Bland-Altman methods, will examine systematic differences and the dispersion of differences between the mobile tool and the reference systems. Correlation analyses will provide complementary information about associations between measurements.
The study will also describe the distribution of pendulum-test measurements in the healthy sample. Demographic and anthropometric characteristics will be considered when exploring variation in these measurements. The resulting reference values will be regarded as preliminary and specific to the population and procedures studied.
Validation in healthy adults will provide initial evidence about measurement performance. It will not, by itself, establish diagnostic accuracy for neurological disorders or demonstrate that all measurement properties are preserved in people with abnormal muscle tone. These limits will be considered when interpreting the subsequent clinical findings.
Study 2: exploratory clinical evaluation.
The second study will investigate whether changes following ETI differ from those following a simulated intervention. The sham comparison is intended to account partly for therapist attention, interpersonal interaction, and expectations associated with receiving treatment.
The intervention is individualized within a standardized framework, with maneuver selection informed by the participant's initial postural assessment. The therapeutic rationale involves eliciting responses in the lower limbs through maneuvers performed in another limb, supported by the breathing pattern specified for ETI. The sham intervention preserves external similarities while omitting the principal components intended to produce induction.
Group assignment will use a sequential balancing procedure that considers relevant baseline characteristics. This approach seeks to improve initial comparability but does not constitute randomization or eliminate the possibility of selection bias and residual confounding.
To reduce variation related to treatment delivery, the treating physiotherapists will follow agreed protocols and each will provide interventions in both groups. Outcome assessment will be performed by a physiotherapist who is not involved in intervention delivery and is unaware of group assignment. Treating physiotherapists cannot be blinded to the procedures they deliver.
Interpretation and analytical approach.
The clinical analysis will examine changes over time and differences in change between groups. Longitudinal analyses will consider intervention group and assessment time, with methods selected according to the characteristics of the data and the assumptions of the statistical models. Effect sizes will complement significance testing to characterize the magnitude of observed differences.
Exploratory analyses will examine whether the neuromuscular responses recorded during treatment are associated with changes in biomechanical, postural, or patient-reported outcomes. Such associations will be interpreted as hypothesis-generating and will not establish a causal mechanism.
Session completion, perceived effort, and recorded clinical incidents will inform the assessment of feasibility and tolerability. These findings will help determine whether the intervention and assessment procedures are suitable for a larger study and which aspects require refinement.
Given the pilot sample, nonrandom allocation, and short follow-up period, the clinical findings will be interpreted as preliminary. The project is intended to provide initial measurement evidence, estimates of possible treatment effects, and practical information for planning subsequent confirmatory research.
- Conditions
- Multiple Sclerosis
- Being tested
- Experimental: Inductive Therapeutic Exercise (ETI), Control: Sham Inductive Therapeutic Exercise (sham-ETI)
- Keywords
- Mobile application, Inertial measurement unit, Measurement validation, Postural control, Health-related quality of life, Physical therapy, Sham-controlled study
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Inductive Therapeutic Exercise (ETI)Other
Physiotherapist-supervised exercise combining specific active limb movements with slow, deep breathing emphasizing expiration (approximately 5-6 breaths per minute), intended to elicit involuntary neuromuscular responses in other body regions. An upper-limb maneuver targets responses in the lower limbs, and a lower-limb maneuver targets responses in the opposite lower limb; both are performed bilaterally. Upper-limb maneuver selection follows the initial postural assessment: shoulder abduction with internal rotation for predominant thoracolumbar lateral flexion, or shoulder flexion with external rotation for a predominant rotational pattern. Treatment comprises eight weekly individual sessions of approximately 40 minutes. Maneuvers are stopped for excessive fatigue, intense pain, or inability to control induced responses.
Control: Sham Inductive Therapeutic Exercise (sham-ETI)Other
Physiotherapist-supervised simulated exercise resembling the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") maneuvers but performed without reaching the movement range intended to trigger involuntary neuromuscular responses. The therapist provides greater manual support, and the specific slow breathing pattern emphasizing expiration used in ETI is not applied. The intervention comprises eight weekly individual sessions of approximately 40 minutes, matching the experimental intervention in session frequency, duration, and individual therapist contact. The same criteria for stopping maneuvers apply as in the ETI intervention.
| Study group | Role | What they receive |
|---|---|---|
| Inductive Therapeutic Exercise (ETI) | Experimental | Participants will receive one individual session of Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") per week for 8 weeks, with each session lasting approximately 40 minutes. Trained physiotherapists will deliver standardized maneuvers selected according to the participant's initial postural assessment. The protocol combines specific active movements with slow, deep breathing emphasizing expiration, at approximately 5-6 breaths per minute. It includes an upper-limb maneuver intended to elicit involuntary neuromuscular responses in the lower limbs and a lower-limb maneuver intended to elicit responses in the opposite lower limb. Both maneuvers will be performed bilaterally. Perceived effort, induced responses, and clinical incidents will be recorded. Maneuvers will be stopped in the event of excessive fatigue, intense pain, or inability to control the induced responses. Receives: Other: Experimental: Inductive Therapeutic Exercise (ETI) |
| Sham Inductive Therapeutic Exercise (sham-ETI) | Sham comparator | Participants will receive one individual session of Sham Inductive Therapeutic Exercise (sham-ETI), a simulated intervention, per week for 8 weeks, with each session lasting approximately 40 minutes. Trained physiotherapists will deliver movements that resemble those used in the experimental arm, without reaching the movement range intended to trigger involuntary neuromuscular responses and with greater manual support from the therapist. The specific breathing pattern used to facilitate induction in the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") arm will not be applied. This comparison is intended to account partly for therapist attention, interaction, and participant expectations. Perceived effort and clinical incidents will be recorded, and the same criteria for stopping maneuvers will apply as in the experimental arm. Receives: Other: Control: Sham Inductive Therapeutic Exercise (sham-ETI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone: change in lower-limb pendulum test first swing excursion
Change from baseline in first swing excursion during the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. First swing excursion is the angular difference between the initial release position and the first reversal point of the pendular movement, expressed in degrees. This parameter characterizes the initial swing of the relaxed lower leg and contributes to the biomechanical assessment of muscle tone. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Muscle tone: change in lower-limb pendulum test relaxation index
Change from baseline in the relaxation index (RI) derived from the lower-limb pendulum test using the mobile measurement tool developed and validated in the preparatory study. RI is calculated as (initial angle - first reversal angle) / (initial angle - resting angle). The initial angle is the limb position at release, the first reversal angle is the position at the end of the first swing, and the resting angle is the final equilibrium position after oscillations cease. RI is dimensionless. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Muscle tone: change in lower-limb pendulum test damping ratio
Change from baseline in the damping ratio derived from the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. This dimensionless parameter characterizes the damping of limb oscillations following release and contributes to the biomechanical assessment of muscle tone. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Muscle tone: change in lower-limb pendulum test logarithmic decrement
Change from baseline in the logarithmic decrement derived from the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. This dimensionless parameter quantifies the progressive reduction in oscillation amplitude using logarithmic ratios of successive peak amplitudes. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Muscle tone: change in lower-limb pendulum test oscillation duration
Change from baseline in the total duration of oscillations during the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. Duration is measured in seconds from limb release until the oscillations cease. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Muscle tone: change in lower-limb pendulum test number of oscillations
Change from baseline in the number of oscillations recorded during the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. This outcome is expressed as the number of oscillations occurring between limb release and rest. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Standing postural control: change in center of pressure 95% ellipse area
Change from baseline in the area of the 95% ellipse of center of pressure positions during a standardized quiet-standing assessment using a pressure platform. The ellipse is calculated from the distribution of anteroposterior and mediolateral center of pressure coordinates and characterizes the spatial extent of postural sway. Area is expressed in square millimeters (mm^2). Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Standing postural control: change in mean center of pressure velocity
Change from baseline in mean center of pressure velocity during a standardized standing balance assessment using a pressure platform. Mean velocity represents the total distance traveled by the center of pressure divided by the recording duration and is expressed in millimeters per second. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Standing postural control: change in anteroposterior center of pressure RMS displacement
Change from baseline in the root mean square (RMS) of anteroposterior center of pressure displacement during a standardized quiet-standing assessment using a pressure platform. RMS displacement is calculated as the square root of the mean squared deviations of anteroposterior center of pressure coordinates from their mean position during the recording. It characterizes sway amplitude along the anteroposterior axis and is expressed in millimeters. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Standing postural control: change in mediolateral center of pressure RMS displacement
Change from baseline in the root mean square (RMS) of mediolateral center of pressure displacement during a standardized quiet-standing assessment using a pressure platform. RMS displacement is calculated as the square root of the mean squared deviations of mediolateral center of pressure coordinates from their mean position during the recording. It characterizes sway amplitude along the mediolateral axis and is expressed in millimeters. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Health-related quality of life: change in MSQoL-54 physical health composite score
Change from baseline in the physical health composite score of the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54), administered using its validated Spanish version. The composite is calculated from a weighted combination of component scale scores according to the instrument's scoring instructions. Scores range from 0 to 100, with higher scores indicating better physical health-related quality of life. Positive changes indicate improvement. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change in Multiple Sclerosis Quality of Life-54 mental health composite score
Change from baseline in the mental health composite score of the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54), administered using its validated Spanish version. This composite combines emotional well-being, role limitations due to emotional problems, cognitive function, health distress, and overall quality of life. It is a separate score from the physical health composite reported in Outcome Measure 11. Scores range from 0 to 100, with higher scores indicating better mental health-related quality of life. Positive changes indicate improvement. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise and sham intervention groups.
Measured: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Secondary outcomes (3)
Adherence: number of intervention sessions completed
Number of intervention sessions completed by each participant during the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") or Sham Inductive Therapeutic Exercise (sham-ETI) program, recorded by the treating physiotherapist in the study case report form. Values range from 0 to 8 completed sessions, with higher values indicating greater adherence. Session completion will be summarized for each intervention group.
Measured: Throughout the 8-week intervention period.
Tolerability: number of participants requiring interruption of intervention maneuvers
Number of participants with at least one intervention maneuver stopped because of excessive fatigue, intense pain, or inability to control induced neuromuscular responses during the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") or Sham Inductive Therapeutic Exercise (sham-ETI) program. The treating physiotherapist will record each interruption and its reason in the study case report form. Each participant will be counted once for this outcome, regardless of the number of interruptions. Interruptions for unrelated logistical reasons will not be included.
Measured: During intervention sessions throughout the 8-week treatment period.
Number of participants with intervention-related clinical incidents
Number of participants experiencing at least one clinical incident considered related to Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") or Sham Inductive Therapeutic Exercise (sham-ETI) during the intervention or follow-up period. Incidents will be documented in the study case report form and reviewed by the principal investigator to assess their relationship to the intervention. The nature of each incident will be described. Each participant will be counted once for this outcome, regardless of the number of incidents experienced.
Measured: From the first intervention session through the follow-up assessment approximately one month after completion of the 8-week intervention (approximately week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study uses a nonrandomized, parallel-group design comparing Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") with Sham Inductive Therapeutic Exercise (sham-ETI), a simulated intervention. Participants are assigned through a sequential balancing procedure conducted by a researcher not involved in outcome assessments, considering age, disease duration, and baseline muscle tone and postural control. Both groups receive one individual session per week for 8 weeks. Outcomes are assessed at baseline, immediately after the intervention period, and one month later. The outcome assessor is blinded to group assignment. The preceding observational tool-validation study is a separate preparatory component of ETOTUR and is not an intervention arm.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación San Juan De Dios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos J Carpintero Rubio, PT, PhD, Principal investigator, Escuela Universitaria de Enfermería y Fisioterapia San Juan de Dios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847853
- Sponsor's protocol ID
- ETOTUR - P26_09
- Other IDs
- PI26/09
- Acronym
- ETOTUR
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpintero-Rubio C, Torres-Chica B, Moreno-Alcántara J, Vera-Saura P, Galvañ-Serrano C. Reconstruction posturale, une modalité d'exercice thérapeutique inductif. Kinésithérapie, la Revue. 2022;22(241):10-15. doi:10.1016/j.kine.2021.11.005.
Sun R, Moon Y, McGinnis RS, Seagers K, Motl RW, Sheth N, Wright JA, Ghaffari R, Patel S, Sosnoff JJ. Assessment of Postural Sway in Individuals with Multiple Sclerosis Using a Novel Wearable Inertial Sensor. Digit Biomark. 2018 Jan 23;2(1):1-10. doi: 10.1159/000485958. eCollection 2018 Jan-Apr.
PubMed 32095755Aymerich M, Guillamon I, Perkal H, Nos C, Porcel J, Berra S, Rajmil L, Montalban X. [Spanish adaptation of the disease-specific questionnaire MSQOL-54 in multiple sclerosis patients]. Neurologia. 2006 May;21(4):181-7. Spanish.
PubMed 16832772Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.
PubMed 7613530Etoom M, Khraiwesh Y, Lena F, Hawamdeh M, Hawamdeh Z, Centonze D, Foti C. Effectiveness of Physiotherapy Interventions on Spasticity in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2018 Nov;97(11):793-807. doi: 10.1097/PHM.0000000000000970.
PubMed 29794531Rahimi F, Eyvazpour R, Salahshour N, Azghani MR. Objective assessment of spasticity by pendulum test: a systematic review on methods of implementation and outcome measures. Biomed Eng Online. 2020 Nov 9;19(1):82. doi: 10.1186/s12938-020-00826-8.
PubMed 33168030
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inductive Therapeutic Exercise on Muscle Tone, Postural Control, and Quality of Life in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT07847853
- Acronym / sponsor ID
- ETOTUR / ETOTUR - P26_09
- Conditions
- Multiple Sclerosis
- Keywords
- Mobile application, Inertial measurement unit, Measurement validation, Postural control, Health-related quality of life, Physical therapy, Sham-controlled study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación San Juan De DiosUniversity, hospital or other
- Study start
- Oct 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Sep 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.
ETOTUR is a research project comprising two complementary stages. The first is an observational study in approximately 50 healthy adults to develop and validate a mobile tool for quantitative assessment of muscle tone using the pendulum test. Measurements obtained with the mobile tool will be compared with laboratory reference systems, and preliminary reference values will be established.
The second stage, which is the focus of this clinical trial registration, is a pilot controlled study involving approximately 30 adults with multiple sclerosis and altered muscle tone and standing postural control. Participants will receive either Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") or Sham Inductive Therapeutic Exercise (sham-ETI), a simulated intervention, with one individual session of approximately 40 minutes per week for 8 weeks.
ETI combines specific active movements and breathing patterns intended to elicit involuntary neuromuscular responses in other body regions. Sham-ETI uses similar movements while omitting the principal movement and breathing components intended to produce induction.
Participants will be assigned using a nonrandom sequential balancing procedure based on relevant baseline characteristics. Outcome assessment will be performed by a physiotherapist blinded to group allocation.
Outcomes will be assessed at baseline, immediately after the 8-week intervention, and approximately one month later. The main outcomes are lower-limb muscle tone assessed using the pendulum test, standing postural control measured with a pressure platform, and health-related quality of life assessed with the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54). Adherence, tolerability, and intervention-related clinical incidents will also be recorded.
The study will explore whether changes following ETI differ from those observed after sham-ETI and will provide preliminary information to support the design of subsequent confirmatory research.
Detailed description
Scientific rationale.
ETOTUR combines the development of an accessible biomechanical assessment tool with an exploratory investigation of Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") in multiple sclerosis. The project addresses two related research needs: obtaining reproducible quantitative measurements of limb pendular behavior and investigating whether an intervention intended to elicit involuntary neuromuscular responses can influence muscle tone, postural control, and health-related quality of life.
The rationale for the measurement component is to complement clinical assessment with instrumented recordings that can be obtained using portable technology. The pendulum test characterizes the movement of a relaxed limb after release, including its initial excursion and subsequent oscillations. ETOTUR will investigate whether a mobile tool can capture these features consistently and with sufficient agreement with laboratory reference systems to support its intended research use.
The therapeutic component investigates ETI as an approach combining specific active movements, positioning, and breathing patterns to elicit neuromuscular responses beyond the body region performing the voluntary movement. The working hypothesis is that these responses may influence tonic and postural regulation. This proposed mechanism provides the rationale for the intervention but is not considered established, and the clinical study is not designed to demonstrate the underlying neurophysiological mechanism directly.
Relationship between the two studies.
The project comprises two sequential studies with distinct populations and objectives. Study 1 is an observational, cross-sectional measurement-validation study in healthy adults. Study 2 is a pilot, nonrandomized, controlled intervention study in adults with multiple sclerosis.
The methodological study will inform the subsequent clinical use of the measurement tool. The healthy participants will provide measurement-validation data and preliminary reference values; they will not constitute a treatment comparison group for participants with multiple sclerosis. Analyses will be conducted separately for each study.
The clinical intervention study is the focus of this trial registration. The preparatory validation study is described here to explain the development of the assessment approach and its role within the wider ETOTUR project.
Study 1: development and measurement validation.
The first study will develop and evaluate a mobile assessment system for upper- and lower-limb pendulum testing, incorporating portable inertial sensing. Measurements will be compared with laboratory reference recordings obtained using three-dimensional optical motion capture and high-precision triaxial accelerometry, as appropriate to the measurement being evaluated.
Standardized positioning, calibration, synchronization, and limb-release procedures will be used to reduce avoidable variation. Repeated recordings will allow assessment of measurement consistency under the study conditions.
The analysis will distinguish reliability from agreement between systems. Intraclass correlation coefficients will characterize reliability, while agreement analyses, including Bland-Altman methods, will examine systematic differences and the dispersion of differences between the mobile tool and the reference systems. Correlation analyses will provide complementary information about associations between measurements.
The study will also describe the distribution of pendulum-test measurements in the healthy sample. Demographic and anthropometric characteristics will be considered when exploring variation in these measurements. The resulting reference values will be regarded as preliminary and specific to the population and procedures studied.
Validation in healthy adults will provide initial evidence about measurement performance. It will not, by itself, establish diagnostic accuracy for neurological disorders or demonstrate that all measurement properties are preserved in people with abnormal muscle tone. These limits will be considered when interpreting the subsequent clinical findings.
Study 2: exploratory clinical evaluation.
The second study will investigate whether changes following ETI differ from those following a simulated intervention. The sham comparison is intended to account partly for therapist attention, interpersonal interaction, and expectations associated with receiving treatment.
The intervention is individualized within a standardized framework, with maneuver selection informed by the participant's initial postural assessment. The therapeutic rationale involves eliciting responses in the lower limbs through maneuvers performed in another limb, supported by the breathing pattern specified for ETI. The sham intervention preserves external similarities while omitting the principal components intended to produce induction.
Group assignment will use a sequential balancing procedure that considers relevant baseline characteristics. This approach seeks to improve initial comparability but does not constitute randomization or eliminate the possibility of selection bias and residual confounding.
To reduce variation related to treatment delivery, the treating physiotherapists will follow agreed protocols and each will provide interventions in both groups. Outcome assessment will be performed by a physiotherapist who is not involved in intervention delivery and is unaware of group assignment. Treating physiotherapists cannot be blinded to the procedures they deliver.
Interpretation and analytical approach.
The clinical analysis will examine changes over time and differences in change between groups. Longitudinal analyses will consider intervention group and assessment time, with methods selected according to the characteristics of the data and the assumptions of the statistical models. Effect sizes will complement significance testing to characterize the magnitude of observed differences.
Exploratory analyses will examine whether the neuromuscular responses recorded during treatment are associated with changes in biomechanical, postural, or patient-reported outcomes. Such associations will be interpreted as hypothesis-generating and will not establish a causal mechanism.
Session completion, perceived effort, and recorded clinical incidents will inform the assessment of feasibility and tolerability. These findings will help determine whether the intervention and assessment procedures are suitable for a larger study and which aspects require refinement.
Given the pilot sample, nonrandom allocation, and short follow-up period, the clinical findings will be interpreted as preliminary. The project is intended to provide initial measurement evidence, estimates of possible treatment effects, and practical information for planning subsequent confirmatory research.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This pilot study uses a nonrandomized, parallel-group design comparing Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") with Sham Inductive Therapeutic Exercise (sham-ETI), a simulated intervention. Participants are assigned through a sequential balancing procedure conducted by a researcher not involved in outcome assessments, considering age, disease duration, and baseline muscle tone and postural control. Both groups receive one individual session per week for 8 weeks. Outcomes are assessed at baseline, immediately after the intervention period, and one month later. The outcome assessor is blinded to group assignment. The preceding observational tool-validation study is a separate preparatory component of ETOTUR and is not an intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Inductive Therapeutic Exercise (ETI) | Experimental | Other: Experimental: Inductive Therapeutic Exercise (ETI)Participants will receive one individual session of Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") per week for 8 weeks, with each session lasting approximately 40 minutes. Trained physiotherapists will deliver standardized maneuvers selected according to the participant's initial postural assessment. The protocol combines specific active movements with slow, deep breathing emphasizing expiration, at approximately 5-6 breaths per minute. It includes an upper-limb maneuver intended to elicit involuntary neuromuscular responses in the lower limbs and a lower-limb maneuver intended to elicit responses in the opposite lower limb. Both maneuvers will be performed bilaterally. Perceived effort, induced responses, and clinical incidents will be recorded. Maneuvers will be stopped in the event of excessive fatigue, intense pain, or inability to control the induced responses. |
| Sham Inductive Therapeutic Exercise (sham-ETI) | Sham comparator | Other: Control: Sham Inductive Therapeutic Exercise (sham-ETI)Participants will receive one individual session of Sham Inductive Therapeutic Exercise (sham-ETI), a simulated intervention, per week for 8 weeks, with each session lasting approximately 40 minutes. Trained physiotherapists will deliver movements that resemble those used in the experimental arm, without reaching the movement range intended to trigger involuntary neuromuscular responses and with greater manual support from the therapist. The specific breathing pattern used to facilitate induction in the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") arm will not be applied. This comparison is intended to account partly for therapist attention, interaction, and participant expectations. Perceived effort and clinical incidents will be recorded, and the same criteria for stopping maneuvers will apply as in the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed medical diagnosis of multiple sclerosis.
- Age 18 years or older.
- Ability to understand and follow the instructions required for the study procedures.
- Altered lower-limb muscle tone, demonstrated by pendulum test measurements outside the reference ranges established in the preparatory study and/or normative values reported in the scientific literature.
- Impaired standing postural control, demonstrated by stabilometric parameters consistent with reduced postural stability, such as increased center of pressure displacement, increased mean sway velocity, or increased sway area.
Key exclusion criteria (8 listed)
- Other neurological, neurodegenerative, or musculoskeletal conditions that may interfere with biomechanical or functional assessments.
- Receipt of inductive therapies, neuromodulatory treatments, or specific interventions targeting muscle tone during the previous 6 months.
- Insufficient understanding of Spanish or inability to follow the study instructions.
- Medical contraindication to the proposed interventions or assessments.
- An acute multiple sclerosis exacerbation or clinical relapse in the months preceding study entry, as determined by medical judgment.
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 |
|---|---|---|
| Experimental: Inductive Therapeutic Exercise (ETI)Physiotherapist-supervised exercise combining specific active limb movements with slow, deep breathing emphasizing expiration (approximately 5-6 breaths per minute), intended to elicit involuntary neuromuscular responses in other body regions. An upper-limb maneuver targets responses in the lower limbs, and a lower-limb maneuver targets responses in the opposite lower limb; both are performed bilaterally. Upper-limb maneuver selection follows the initial postural assessment: shoulder abduction with internal rotation for predominant thoracolumbar lateral flexion, or shoulder flexion with external rotation for a predominant rotational pattern. Treatment comprises eight weekly individual sessions of approximately 40 minutes. Maneuvers are stopped for excessive fatigue, intense pain, or inability to control induced responses. | Other | Inductive Therapeutic Exercise (ETI) |
| Control: Sham Inductive Therapeutic Exercise (sham-ETI)Physiotherapist-supervised simulated exercise resembling the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") maneuvers but performed without reaching the movement range intended to trigger involuntary neuromuscular responses. The therapist provides greater manual support, and the specific slow breathing pattern emphasizing expiration used in ETI is not applied. The intervention comprises eight weekly individual sessions of approximately 40 minutes, matching the experimental intervention in session frequency, duration, and individual therapist contact. The same criteria for stopping maneuvers apply as in the ETI intervention. | Other | Sham Inductive Therapeutic Exercise (sham-ETI) |
Primary outcome
Muscle tone: change in lower-limb pendulum test first swing excursion
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in first swing excursion during the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. First swing excursion is the angular difference between the initial release position and the first reversal point of the pendular movement, expressed in degrees. This parameter characterizes the initial swing of the relaxed lower leg and contributes to the biomechanical assessment of muscle tone. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Muscle tone: change in lower-limb pendulum test relaxation index
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the relaxation index (RI) derived from the lower-limb pendulum test using the mobile measurement tool developed and validated in the preparatory study. RI is calculated as (initial angle - first reversal angle) / (initial angle - resting angle). The initial angle is the limb position at release, the first reversal angle is the position at the end of the first swing, and the resting angle is the final equilibrium position after oscillations cease. RI is dimensionless. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Muscle tone: change in lower-limb pendulum test damping ratio
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the damping ratio derived from the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. This dimensionless parameter characterizes the damping of limb oscillations following release and contributes to the biomechanical assessment of muscle tone. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Muscle tone: change in lower-limb pendulum test logarithmic decrement
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the logarithmic decrement derived from the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. This dimensionless parameter quantifies the progressive reduction in oscillation amplitude using logarithmic ratios of successive peak amplitudes. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Muscle tone: change in lower-limb pendulum test oscillation duration
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the total duration of oscillations during the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. Duration is measured in seconds from limb release until the oscillations cease. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Muscle tone: change in lower-limb pendulum test number of oscillations
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the number of oscillations recorded during the lower-limb pendulum test, assessed using the mobile measurement tool developed and validated in the preparatory study. This outcome is expressed as the number of oscillations occurring between limb release and rest. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Standing postural control: change in center of pressure 95% ellipse area
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the area of the 95% ellipse of center of pressure positions during a standardized quiet-standing assessment using a pressure platform. The ellipse is calculated from the distribution of anteroposterior and mediolateral center of pressure coordinates and characterizes the spatial extent of postural sway. Area is expressed in square millimeters (mm^2). Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Standing postural control: change in mean center of pressure velocity
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in mean center of pressure velocity during a standardized standing balance assessment using a pressure platform. Mean velocity represents the total distance traveled by the center of pressure divided by the recording duration and is expressed in millimeters per second. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Standing postural control: change in anteroposterior center of pressure RMS displacement
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the root mean square (RMS) of anteroposterior center of pressure displacement during a standardized quiet-standing assessment using a pressure platform. RMS displacement is calculated as the square root of the mean squared deviations of anteroposterior center of pressure coordinates from their mean position during the recording. It characterizes sway amplitude along the anteroposterior axis and is expressed in millimeters. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Standing postural control: change in mediolateral center of pressure RMS displacement
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the root mean square (RMS) of mediolateral center of pressure displacement during a standardized quiet-standing assessment using a pressure platform. RMS displacement is calculated as the square root of the mean squared deviations of mediolateral center of pressure coordinates from their mean position during the recording. It characterizes sway amplitude along the mediolateral axis and is expressed in millimeters. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Health-related quality of life: change in MSQoL-54 physical health composite score
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the physical health composite score of the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54), administered using its validated Spanish version. The composite is calculated from a weighted combination of component scale scores according to the instrument's scoring instructions. Scores range from 0 to 100, with higher scores indicating better physical health-related quality of life. Positive changes indicate improvement. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise (ETI, from the Spanish "Ejercicio Terapéutico Inductivo") and Sham Inductive Therapeutic Exercise (sham-ETI) groups.
Change in Multiple Sclerosis Quality of Life-54 mental health composite score
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Change from baseline in the mental health composite score of the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54), administered using its validated Spanish version. This composite combines emotional well-being, role limitations due to emotional problems, cognitive function, health distress, and overall quality of life. It is a separate score from the physical health composite reported in Outcome Measure 11. Scores range from 0 to 100, with higher scores indicating better mental health-related quality of life. Positive changes indicate improvement. Changes at postintervention and follow-up assessments will be compared between the Inductive Therapeutic Exercise and sham intervention groups.
3 secondary outcomes
Adherence: number of intervention sessions completed
Time frame: Throughout the 8-week intervention period.
Tolerability: number of participants requiring interruption of intervention maneuvers
Time frame: During intervention sessions throughout the 8-week treatment period.
Number of participants with intervention-related clinical incidents
Time frame: From the first intervention session through the follow-up assessment approximately one month after completion of the 8-week intervention (approximately week 12).
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 2 Oct 2026.
- BackgroundCarpintero-Rubio C, Torres-Chica B, Moreno-Alcántara J, Vera-Saura P, Galvañ-Serrano C. Reconstruction posturale, une modalité d'exercice thérapeutique inductif. Kinésithérapie, la Revue. 2022;22(241):10-15. doi:10.1016/j.kine.2021.11.005.
- Background: PubMed 32095755Sun R, Moon Y, McGinnis RS, Seagers K, Motl RW, Sheth N, Wright JA, Ghaffari R, Patel S, Sosnoff JJ. Assessment of Postural Sway in Individuals with Multiple Sclerosis Using a Novel Wearable Inertial Sensor. Digit Biomark. 2018 Jan 23;2(1):1-10. doi: 10.1159/000485958. eCollection 2018 Jan-Apr.
- Background: PubMed 16832772Aymerich M, Guillamon I, Perkal H, Nos C, Porcel J, Berra S, Rajmil L, Montalban X. [Spanish adaptation of the disease-specific questionnaire MSQOL-54 in multiple sclerosis patients]. Neurologia. 2006 May;21(4):181-7. Spanish.
- Background: PubMed 7613530Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.
- Background: PubMed 29794531Etoom M, Khraiwesh Y, Lena F, Hawamdeh M, Hawamdeh Z, Centonze D, Foti C. Effectiveness of Physiotherapy Interventions on Spasticity in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2018 Nov;97(11):793-807. doi: 10.1097/PHM.0000000000000970.
- Background: PubMed 33168030Rahimi F, Eyvazpour R, Salahshour N, Azghani MR. Objective assessment of spasticity by pendulum test: a systematic review on methods of implementation and outcome measures. Biomed Eng Online. 2020 Nov 9;19(1):82. doi: 10.1186/s12938-020-00826-8.
- 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.
Carlos J Carpintero Rubio, PT, PhD principal investigator
Escuela Universitaria de Enfermería y Fisioterapia San Juan de Dios
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Inductive Therapeutic Exercise (ETI) in people with Multiple Sclerosis, run by Fundación San Juan De Dios at 2 sites 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 6 inclusion and 8 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 2 Oct 2026. 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 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 Carlos J Carpintero Rubio, PT, PhD (+34 637829951, ccarpintero@comillas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle tone: change in lower-limb pendulum test first swing excursion (time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).). The study lists 12 primary outcomes in all. 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 NCT07847853, which also lists 6 linked publications.
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 2 Oct 2026.