Inductive Therapeutic Exercise in Multiple Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Muscle tone: change in lower-limb pendulum test first swing excursion — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (2)

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