Inductive Therapeutic Exercise in Multiple Sclerosis

Study acronym: ETOTUR
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 2 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07847853
Lead Sponsor Fundación San Juan De Dios
Conditions
(from sponsor)
Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov