An interventional study of Experimental: Inductive Therapeutic Exercise (ETI) and Control: Sham Inductive Therapeutic Exercise (sham-ETI) in Multiple Sclerosis, sponsored by Fundación San Juan De Dios. Not yet recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Fundación San Juan De Dios · Not applicable, Interventional, and Treatment
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) or a simulated intervention (sham-ETI), 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 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.
Scientific rationale. ETOTUR combines the development of an accessible biomechanical assessment tool with an exploratory investigation of Inductive Therapeutic Exercise (ETI, from its Spanish name) 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.
Exclusion Criteria:
Participants will receive one individual session of Inductive Therapeutic Exercise (ETI) 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.
Other: Experimental: Inductive Therapeutic Exercise (ETI)
Participants will receive one individual session of simulated Inductive Therapeutic Exercise (sham-ETI) 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 ETI 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.
Other: Control: Sham Inductive Therapeutic Exercise (sham-ETI)
Physiotherapist-supervised exercise combining specific active limb movements with slow, deep breathing emphasizing expiration (approximately 5-6 breaths/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.
Physiotherapist-supervised simulated exercise resembling the ETI 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.
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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 ETI and sham-ETI groups.
Time frame: 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 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. 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 mental health-related quality of life. Positive changes indicate improvement. Changes at postintervention and follow-up assessments will be compared between the ETI and sham-ETI groups.
Time frame: Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).
Adherence: number of intervention sessions completed
Number of intervention sessions completed by each participant during the ETI or 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.
Time frame: 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 ETI or 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.
Time frame: 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 ETI or 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.
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).
Plan to share: No
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