Inductive Therapeutic Exercise in Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación San Juan De Dios
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: Inductive Therapeutic Exercise (ETI)
Other interventionPhysiotherapist-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 interventionPhysiotherapist-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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Inductive Therapeutic Exercise (ETI)Experimental treatment 1 intervention
Group B: Sham Inductive Therapeutic Exercise (sham-ETI)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).2
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.
Time frame
Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).3
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.
Time frame
Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).4
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.
Time frame
Baseline, immediately after the 8-week intervention, and approximately one month after intervention completion (approximately week 12).Secondary outcomes
1
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.
Time frame
Throughout the 8-week intervention period.2
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.
Time frame
During intervention sessions throughout the 8-week treatment period.3
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.
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).Sponsors and contacts
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Source ClinicalTrials.gov
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