NCT07847853Toborzás még nem indult
Inductive Therapeutic Exercise in Multiple Sclerosis
Effects of Inductive Therapeutic Exercise on Muscle Tone, Postural Control, and Quality of Life in Patients With Multiple Sclerosis.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. szept. 22.
- Kezdés
- 2027. okt.
- Elsődleges befejezés
- 2028. júl.
- Fő szponzor
- Fundación San Juan De Dios
- Betegségek
- Sclerosis multiplex (SM)
- NCT-szám
- NCT07847853
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2027. okt. és az elsődleges befejezés (2028. júl.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Receipt of inductive therapies, neuromodulatory treatments, or specific interventions targeting muscle tone during the previous 6 months.
Más betegség
- Other neurological, neurodegenerative, or musculoskeletal conditions that may interfere with biomechanical or functional assessments.
- Uncontrolled arterial hypertension or ocular hypertension.
Egyéb
- 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.
- Inability to maintain sitting or standing for the duration required to complete the biomechanical assessments.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hospital Universitario San Rafael | Madrid | Spanyolország | Ismeretlen állapot |
| Escuela Universitaria de Enfermería y Fisioterapia San Juan de Dios - Universidad Pontificia Comillas | Madrid | Spanyolország | Ismeretlen állapot |
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