Effects of Inductive Therapeutic Exercise on Muscle Tone, Postural Control, and Quality of Life in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Muscle tone: change in lower-limb pendulum test first swing excursion
研究概览
简要总结
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) or a simulated intervention (sham-ETI), 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 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.
详细描述
Scientific rationale. ETOTUR combines the development of an accessible biomechanical assessment tool with an exploratory investigation of Inductive Therapeutic Exercise (ETI, from its Spanish name) in multiple sclerosis. The project addresses two related research needs: obtaining reproducible quantitative measurements of limb pendular behavior and investigating whether an intervention intended to elicit involuntary neuromuscular responses can influence muscle tone, postural control, and health-related quality of life.
The rationale for the measurement component is to complement clinical assessment with instrumented recordings that can be obtained using portable technology. The pendulum test characterizes the movement of a relaxed limb after release, including its initial excursion and subsequent oscillations. ETOTUR will investigate whether a mobile tool can capture these features consistently and with sufficient agreement with laboratory reference systems to support its intended research use.
The therapeutic component investigates ETI as an approach combining specific active movements, positioning, and breathing patterns to elicit neuromuscular responses beyond the body region performing the voluntary movement. The working hypothesis is that these responses may influence tonic and postural regulation. This proposed mechanism provides the rationale for the intervention but is not considered established, and the clinical study is not designed to demonstrate the underlying neurophysiological mechanism directly.
Relationship between the two studies. The project comprises two sequential studies with distinct populations and objectives. Study 1 is an observational, cross-sectional measurement-validation study in healthy adults. Study 2 is a pilot, nonrandomized, controlled intervention study in adults with multiple sclerosis.
The methodological study will inform the subsequent clinical use of the measurement tool. The healthy participants will provide measurement-validation data and preliminary reference values; they will not constitute a treatment comparison group for participants with multiple sclerosis. Analyses will be conducted separately for each study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Inductive Therapeutic Exercise (ETI)
Participants will receive one individual session of Inductive Therapeutic Exercise (ETI) per week for 8 weeks, with each session lasting approximately 40 minutes. Trained physiotherapists will deliver standardized maneuvers selected according to the participant's initial postural assessment. The protocol combines specific active movements with slow, deep breathing emphasizing expiration, at approximately 5-6 breaths per minute. It includes an upper-limb maneuver intended to elicit involuntary neuromuscular responses in the lower limbs and a lower-limb maneuver intended to elicit responses in the opposite lower limb. Both maneuvers will be performed bilaterally. Perceived effort, induced responses, and clinical incidents will be recorded. Maneuvers will be stopped in the event of excessive fatigue, intense pain, or inability to control the induced responses.
干预措施: Experimental: Inductive Therapeutic Exercise (ETI) (Other)
Sham Inductive Therapeutic Exercise (sham-ETI)
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. Trained physiotherapists will deliver movements that resemble those used in the experimental arm, without reaching the movement range intended to trigger involuntary neuromuscular responses and with greater manual support from the therapist. The specific breathing pattern used to facilitate induction in the ETI arm will not be applied. This comparison is intended to account partly for therapist attention, interaction, and participant expectations. Perceived effort and clinical incidents will be recorded, and the same criteria for stopping maneuvers will apply as in the experimental arm.
干预措施: Control: Sham Inductive Therapeutic Exercise (sham-ETI) (Other)
结局指标
主要结局
Muscle tone: change in lower-limb pendulum test first swing excursion
时间窗: 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 ETI and sham-ETI groups.
Muscle tone: change in lower-limb pendulum test relaxation index
时间窗: 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 ETI and sham-ETI groups.
Muscle tone: change in lower-limb pendulum test damping ratio
时间窗: 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 ETI and sham-ETI groups.
Muscle tone: change in lower-limb pendulum test logarithmic decrement
时间窗: 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 ETI and sham-ETI groups.
Muscle tone: change in lower-limb pendulum test oscillation duration
时间窗: 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 ETI and sham-ETI groups.
Muscle tone: change in lower-limb pendulum test number of oscillations
时间窗: 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 ETI and sham-ETI groups.
Standing postural control: change in center of pressure 95% ellipse area
时间窗: 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 ETI and sham-ETI groups.
Standing postural control: change in mean center of pressure velocity
时间窗: 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 ETI and sham-ETI groups.
Standing postural control: change in anteroposterior center of pressure RMS displacement
时间窗: 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 ETI and sham-ETI groups.
Standing postural control: change in mediolateral center of pressure RMS displacement
时间窗: 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 ETI and sham-ETI groups.
Health-related quality of life: change in MSQoL-54 physical health composite score
时间窗: 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 ETI and sham-ETI groups.
Health-related quality of life: change in MSQoL-54 mental health composite score
时间窗: 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. 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 mental health-related quality of life. Positive changes indicate improvement. Changes at postintervention and follow-up assessments will be compared between the ETI and sham-ETI groups.
次要结局
- Adherence: number of intervention sessions completed(Throughout the 8-week intervention period.)
- Tolerability: number of participants requiring interruption of intervention maneuvers(During intervention sessions throughout the 8-week treatment period.)
- 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).)