Pilot Study of Inductive Therapeutic Exercise in Adults with Multiple Sclerosis
The study compared Inductive Therapeutic Exercise (ETI) to a sham version (sham-ETI) in adults with multiple sclerosis over 8 weeks. After the intervention and a follow-up at one month, outcomes related to muscle tone were assessed by a blinded physiotherapist. Results are currently unavailable as the study is still in progress.
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Why it matters
This pilot study may offer insights into the effects of ETI on muscle tone in adults with MS, potentially guiding future interventions, although comprehensive results are yet to be defined.
What this does not prove
The study is not randomized, potentially leading to selection bias. It is also a pilot study with a short follow-up, meaning findings may not be fully reliable or generalizable.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- All
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
- Trial registrationInductive Therapeutic Exercise in Multiple Sclerosis ↗
Supporting passages (13)
study designThis pilot study uses a nonrandomized, parallel-group design comparing Inductive Therapeutic Exercise (ETI) with a simulated intervention (sham-ETI).
subjectsMeasurements obtained with the mobile tool will be compared with laboratory reference systems, and preliminary reference values will be established.\n\nThe 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.
randomizedStudy 2 is a pilot, nonrandomized, controlled intervention study in adults with multiple sclerosis.\n\nThe methodological study will inform the subsequent clinical use of the measurement tool.
controlledStudy 2 is a pilot, nonrandomized, controlled intervention study in adults with multiple sclerosis.\n\nThe methodological study will inform the subsequent clinical use of the measurement tool.
peer reviewedNo results are posted.
regulatory approvalThe preceding observational tool-validation study is a separate preparatory component of ETOTUR and is not an intervention arm.",
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\n* Confirmed medical diagnosis of multiple sclerosis.\n* Age 18 years or older.\n* Ability to understand and follow the instructions required for the study procedures.\n* 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.\n* 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.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Other neurological, neurodegenerative, or musculoskeletal conditions that may interfere with biomechanical or functional assessments.\n* Receipt of inductive therapies, neuromodulatory treatments, or specific interventions targeting muscle tone during the previous 6 months.\n* Insufficient understanding of Spanish or inability to follow the study instructions.\n* Medical contraindication to the proposed interventions or assessments.\n* An acute multiple sclerosis exacerbation or clinical relapse in the months preceding study entry, as determined by medical judgment.\n* Pregnancy.\n* Uncontrolled arterial hypertension or ocular hypertension.\n* Inability to maintain sitting or standing for the duration required to complete the biomechanical assessments.",
intervention"description": "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.
comparator"description": "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.
primary endpoint"description": "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.
follow upOutcomes will be assessed at baseline, immediately after the 8-week intervention, and approximately one month later.
findingsOutcome assessment will be performed by a physiotherapist blinded to group allocation.
limitationsThis approach seeks to improve initial comparability but does not constitute randomization or eliminate the possibility of selection bias and residual confounding.\n\nTo reduce variation related to treatment delivery, the treating physiotherapists will follow agreed protocols and each will provide interventions in both groups.
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