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NCT Number: NCT07795216

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

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.

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Key information

Conditions

Quality of Life PROMs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center

Nijmegen, Gelderland, 6525, Netherlands

Location status: Recruiting

Location contact

Indy Smits, MSc

CONTACT

[email protected]

+243614892

Niek Koenders, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

questionnaires

Other

PROMIS Questionnaires

Primary outcomes

  1. Health-related quality of life measured by PROMIS® Global-02

    Time frame: 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.

Secondary outcomes

  1. Perceived health measured by PROMIS® Global01

    Time frame: 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.

  2. Social functioning measured by PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a

    Time frame: 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.

  3. Physical functioning measured by PROMIS® Physical Function Short Form 8b

    Time frame: 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.

  4. Anxiety measured by PROMIS® Anxiety Short Form 4a

    Time frame: 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.

  5. Depressive symptoms measured by PROMIS® Depression Short Form 4a

    Time frame: 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

  6. Fatigue measured by PROMIS® Fatigue Short Form 4a

    Time frame: 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.

  7. Pain intensity measured by PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Indy Smits, MSc

CONTACT

[email protected]

+243614892

Niek Koenders, PhD

CONTACT

+243614892

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: AFTER-TRAUMA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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