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Résztvevőt keres itt: KanadaFázis nélkül

Postural Sway and Counterpressure Maneuvers for Pediatric Syncope

A legfontosabb adatok

Ki végzi
Simon Fraser University
Hol
Burnaby (Kanada)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
30 fő, tervezett
Kezdés
2023. ápr. 17.
Várható befejezés
2027. jún.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport színlelt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Counterpressure Maneuvers
  • Baseline Stand
A regiszteradat frissítve
2026. április 23.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for English-speaking children and teens who faint again and again, from a vasovagal cause or linked to POTS. It tests simple leg and body muscle movements.

Életkor
6 to 18 years
Nem
All sexes
A betegség stádiuma
Recurrent fainting: at least two episodes of fainting or near-fainting in the last year. The cause must be vasovagal or linked to postural orthostatic tachycardia syndrome (POTS), as found by a paediatric cardiologist.
Korábbi kezelés
People cannot join if they take any heart or blood-vessel medicines, or medicines for fainting on standing (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine). Full COVID-19 vaccination under Health Canada guidelines is needed, with proof.

A részvétel fő kizáró okai

  • Known or suspected heart rhythm problem (e.g. Wolff-Parkinson-White, Long QT) or structural heart disease
  • Head injury, new seizures or return of epilepsy, overdose or intoxication
  • Heart or blood-vessel disease, including high blood pressure, diabetes or kidney disease, or low blood sugar
  • Physical or mental disability that affects doing the tests
  • Being pregnant or thinking you might be

A regiszter feltételei, szó szerint

Mind a 11 feltétel megnézéseKevesebb

Ki vehet részt

  • We are looking for English speaking pediatric patients aged 6-18 years with a diagnosis of recurrent fainting (at least two episodes of fainting with loss of consciousness or near loss of consciousness in the last year) of a vasovagal origin or associated with the postural orthostatic tachycardia syndrome (POTS) (as determined by a paediatric cardiologist) to take part in this study

Ki nem vehet részt

  • Known history of:
  • New presentation of a seizure disorder OR epilepsy recurrence
  • Structural heart disease
  • Cardiovascular disease including hypertension, diabetes, or renal disease
  • Suspected or confirmed cardiac arrhythmia (e.g., Wolff-Parkinson-White, Long QT)
  • Physical and/or psychological disability that impact their ability to complete the tests; Female participants of childbearing age will be excluded if they are pregnant, or think they might be. Participants who are taking any cardiovascular acting medications, including treatment for cardiovascular disease, or medications for orthostatic syncope (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine) will be excluded from the study; In order to reduce the likelihood of transmission of COVID-19, participants will only be eligible to participate in the study if they have received full immunisation against COVID-19 according to current Health Canada guidelines. Accordingly, participants will be asked to provide evidence of their vaccination status in order to take part in the study
  • Those with a diagnosis of recurrent fainting accompanied by any of the following will not be eligible to take part:
  • Traumatic head injury
  • Overdose or intoxication
  • Hypoglycemia

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 6 és 18 év között vagy?

Helyszínek itt: Kanada

  • Simon Fraser UniversityBurnaby, KanadaContact: Victoria Claydon, PhDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The investigators are interested in whether discrete counterpressure maneuvers, or muscle movements in the lower body, will boost blood pressure and cardiovascular control in children who faint. We will record cardiovascular responses to maneuvers of exaggerated sway, leg crossing, crouching, and gluteal muscle tensing in children who faint (N=20), as well as their height, weight, muscularity, and pubertal (Tanner) stage. Autonomic cardiovascular control will be measured using a Valsalva manoeuvre (expiration against a closed airway for 20 seconds) and a supine-stand test. The primary outcomes are noninvasive measures of cardiovascular responses to the maneuvers (blood pressure, cerebral blood flow, and stroke volume (volume of blood pumped per heartbeat). Comparisons will be made across levels of sex, diagnosis, Tanner stage, muscularity, height, and degree of autonomic control.

A vizsgálat 2 csoportja

  • Counterpressure ManeuversA vizsgált kezelés

    Counterpressure maneuver (CPM) trials will be performed in front of a neutral wall in silence to ensure that visual or auditory stimuli do not affect movement. CPM: * Leg crossing and muscle tensing: Legs are crossed while upright and lower body musculature is isometrically contracted (clinical) * Crouching: Participant crouches down resting weight on the balls of their feet, pressing calves against the back surface of the thighs (clinical) * Exaggerated anterior-posterior sway: Participant sways back and forth with feet planted on ground at a pace/amplitude that is comfortable (discrete) * Gluteal clenching: Participant rhythmically tenses and relaxes the gluteal muscles at a pace/duration that is comfortable (discrete) Participants serve as their own controls and complete both testing arms.

    Kezelés: Counterpressure Maneuvers és Baseline Stand

  • Baseline StandSzínlelt kezelés, összehasonlításként

    Participants will perform a sit-stand test, followed by 5-minutes of baseline (quiet) standing trial on a force platform while cardiorespiratory responses are recorded. Sit-stand test: following 5-minutes of supine rest, the participant will be passively moved into the seated position. They will then be asked to actively move into the standing position. Baseline stand: immediately following the sit-stand test, the baseline trial will begin. Participants will stand quietly on the force platform for 5-minutes. This trial will be performed in front of a neutral wall in silence to ensure that visual or auditory stimuli do not affect their movement. Participants serve as their own controls and complete both testing arms.

    Kezelés: Counterpressure Maneuvers és Baseline Stand

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Impact of Postural Sway on Cardiovascular Control in Pediatric Patients With Syncope
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT05633693: ki vehet részt
A regiszteradat frissítve
2026. április 23.