ETOTUR: in MS (type not specified), not a drug-phase study

What was tested

Treatment tested

Experimental: Inductive Therapeutic Exercise (ETI)

Placebo

Control: Sham Inductive Therapeutic Exercise (sham-ETI)

What it measured

Main measures

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).
Physical function
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).
Physical function
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).
Physical function
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).
Physical function
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).
Physical function
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).
Physical function
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).
Physical function
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).
Walking and mobilityPhysical function
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).
Physical function
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).
Physical function
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).
Physical functionQuality of life (reported by participants)
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).
Thinking and memoryPhysical functionQuality of life (reported by participants)

Other measures (3)

Adherence: number of intervention sessions completed
Throughout the 8-week intervention period.
Physical functionQuality of life (reported by participants)
Tolerability: number of participants requiring interruption of intervention maneuvers
During intervention sessions throughout the 8-week treatment period.
FatiguePhysical functionPainSafety
Number of participants with intervention-related clinical incidents
From the first intervention session through the follow-up assessment approximately one month after completion of the 8-week intervention (approximately week 12).
Physical function

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* 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.

Exclusion criteria

* 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

History

Started
Oct 2027
Main results due
Jul 2028
Finished
Jul 2028

Inductive Therapeutic Exercise in Multiple Sclerosis

What it found