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Affordable, Tailored Physical Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA) (AFTER-TRAUMA)

26. srpna 2026 aktualizováno: Radboud University Medical Center

Affordable, Tailored Physical Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA): a Prospective Cohort Study

SUMMARY

Rationale: In the Netherlands, trauma-related injuries affect more than 700,000 people annually, and many require rehabilitation. Regardless of trauma-related injuries, over 500,000 individuals live in financial vulnerability, often characterized as having low socioeconomic status (SES). Patients with low SES have an increased risk of sustaining trauma and generally experience poorer recovery outcomes. Access to physical therapy care is limited for this population, despite the substantial impact of trauma on quality of life and daily functioning. Little is known about their long-term rehabilitation outcomes. This study aims to improve understanding of recovery patterns in patients with trauma-related injuries and explores whether outcomes differ between SES-groups.

Objective: The primary objective is to assess quality of life 1 week prior to the injury, and at 1 week, 6 weeks, 12 weeks, 6 months, and 1 year after trauma-related injury. Secondary objectives include evaluating social, physical and mental functioning, fatigue, pain, and return-to-work. Outcomes will be compared across socioeconomic groups to explore how financial vulnerability is associated with recovery.

Study design: Prospective, longitudinal cohort study. Study population: In total 185 patients (≥18 years) with trauma-related injuries (ISS ≥9) admitted to the Radboud University Medical Center will be included between April 2026 and October 2027.

Main study parameters/endpoints: The primary outcome is quality of life, measured using validated PROMIS® Global02 at all follow-up timepoints. Secondary outcomes include perceived health, social, physical, and mental functioning, fatigue, and pain, assessed using validated PROMIS® questionnaires at the same follow up moments. SES indicators (postal code, education level, type of employment), health insurance coverage, and work status will also be collected.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Participation involves minimal burden and no medical risks. Patients are asked to complete digital of paper questionnaires at predefined intervals with a burden of approximately 10 minutes per follow-up interval. No additional procedures or treatments are required. The participant will receive a compensation of €5 for each completed questionnaire. The study is expected to generate valuable insights that can improve quality, accessibility, and tailoring of physical therapy care for future trauma patients, particularly those in a financially vulnerable situation.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

153

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Niek Koenders, PhD
  • Telefonní číslo: +243614892

Studijní místa

  • Holandsko
    • Gelderland
      • Nijmegen, Gelderland, Holandsko, 6525
        • Nábor
        • Radboud University Medical Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Niek Koenders, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The study population consists of patients 18 years or older with trauma-related injuries admitted to the Radboud University Medical Center (Radboudumc). In the Netherlands, 722,050 people experience trauma-related injuries each year [1]. In 2024, a total of 75,232 patients with injuries were registered in the National Trauma Registry (LRT) [13]. At the Radboud University Medical Center, we treated 508 severely injured patients in 2024 (Injury Severity Score (ISS) ≥16). Data for patients with an ISS between 9 and 15, treated at the Radboud University Medical Center, is not available.

Popis

Inclusion Criteria:

  1. Adults ≥ 18 years
  2. Trauma-related injury and an Injury Severity Score (ISS) ≥ 9 points
  3. Admitted ≥ 24 hours to the Radboudumc

Exclusion Criteria:

  1. Delirium, dementia, or depression
  2. Unable to participate in the informed consent procedure
  3. Life expectancy < 3 months

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Multitrauma
Trauma patients with an ISS >8
Jiný: Questionnaires
PROMIS Questionnaires

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health-related quality of life measured by PROMIS® Global-02
Časové okno: 1 week before injury (retrospectively assessed at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Health-related quality of life is assessed using PROMIS® Global02. Participants rate their overall quality of life on a 5-point scale ranging from 1 (poor) to 5 (excellent). Higher scores indicate better health-related quality of life.
1 week before injury (retrospectively assessed at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Perceived health measured by PROMIS® Global01
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Perceived health is assessed using PROMIS® Global01. Participants rate their overall health on a 5-point scale ranging from 1 (poor) to 5 (excellent). Higher scores indicate better perceived health.
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Social functioning measured by PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Social functioning is assessed using the PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a. The questionnaire contains 4 items scored on 5-point response scales. Total scores range from 4 to 20. Higher scores indicate better social functioning and participation.
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Physical functioning measured by PROMIS® Physical Function Short Form 8b
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Physical functioning is assessed using the PROMIS® Physical Function Short Form 8b. The questionnaire contains 8 items scored on 5-point response scales. Total scores range from 8 to 40. Higher scores indicate better physical functioning.
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Anxiety measured by PROMIS® Anxiety Short Form 4a
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Anxiety is assessed using the PROMIS® Anxiety Short Form 4a. The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20. Higher scores indicate greater anxiety symptoms.
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Depressive symptoms measured by PROMIS® Depression Short Form 4a
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Depressive symptoms are assessed using the PROMIS® Depression Short Form 4a. The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20. Higher scores indicate greater depressive symptoms
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Fatigue measured by PROMIS® Fatigue Short Form 4a
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Fatigue is assessed using the PROMIS® Fatigue Short Form 4a. The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20. Higher scores indicate greater fatigue.
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Pain intensity measured by PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a
Časové okno: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
Pain intensity is assessed using the PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a. Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Radboud University Medical Center

Vyšetřovatelé

  • Studijní židle: Niek Koenders, PhD, Radboud University Medical Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. dubna 2026

Primární dokončení (Odhadovaný)

30. září 2027

Dokončení studie (Odhadovaný)

30. září 2027

Termíny zápisu do studia

První předloženo

17. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

26. srpna 2026

První zveřejněno (Aktuální)

31. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

31. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NL2026-18844
  • WCF CALL 2024-2025 (Jiné číslo grantu/financování: Wetenschappelijk College Fysiotherapie (KNGF))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Not allowed

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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