NCT06399614

Brief Summary

Traumatic hand injuries account for up to one third of acute hospital presentations. Current guidelines and standards of care recommend patients with hand trauma are seen by hand therapists, typically occupational therapists. The proposed study aims to explore the effectiveness of occupational therapy-led hand therapy services for the adult population presenting acutely to an injury unit or emergency department setting with a hand condition. The research project will consist of an analytical study, involving four different sites in Ireland to enrich findings, and to aid future service development. One site will be the comparison site, as it does not have access to occupational therapy, and will offer patients 'care as usual' upon attendance. Outcome measures will be used for all participants and will be completed at initial patient contact, at week eight and at six months. It is hoped the current proposed study will help shape future service development for those with hand injury including provision of evidence based occupational therapy assessment and intervention.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

March 27, 2024

Last Update Submit

September 25, 2025

Conditions

Keywords

Hand injuryHand conditionsOccupational Therapy

Outcome Measures

Primary Outcomes (1)

  • Function: our primary outcome is change in patient function for those with acutely presenting hand conditions.

    The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) outcome measure is a self report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. The QuickDASH contains an 11 item disability/symptom scale, with two optional scales capturing sport/art and work ability. The QuickDASH is valid, reliable and has demonstrated high responsive in outpatients with hand trauma and degenerative hand conditions and can be used for clinical and research purposes. A lower score on the QuickDASH denotes lower disability, whilst a high score denotes higher rates of disability.

    The QuickDASH will be administered at baseline, at 8-weeks (post intervention), and at six months.

Secondary Outcomes (4)

  • Change in health related quality of life for those with acutely presenting hand conditions using a visual scale.

    The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.

  • Change in health related quality of life for those with acutely presenting hand conditions using a descriptive system.

    The EuroQoL EQ-5D-5L will be administered at baseline, at 8-weeks (post intervention), and at six months.

  • Occupational Value and Competence of those with acutely presenting hand conditions.

    The Occupational Self Assessment - Short Form (OSA-SF) will be administered at baseline, at 8-weeks (post intervention), and at six months.

  • Pain reported by those with acutely presenting hand conditions.

    The pain verbal rating scale will be administered at baseline, at 8-weeks (post intervention), and at six months.

Study Arms (2)

Intervention Group

Participants who attend an emergency department or injury unit with access to occupational therapy will be referred to an occupational therapy-led hand therapy clinic. Assessment and intervention for their hand injury will be provided by the occupational therapist, based on existing hand therapy protocols and guidelines. The consultant in charge and the occupational therapist will make clinical judgements with regard suitability for occupational therapy clinics for conservative management of their condition based on patient need at point of triage. Types of interventions provided by the occupational therapist will include customised splinting, targeted exercises and activities, swelling reduction, scar management, desensitisation, education on type of injury, and occupation based intervention. All interventions provided are within occupational therapists' scope of practice and are evidence based.

Other: Occupational Therapy-led Hand Therapy Service

Care as Usual Group

Participants attending an emergency department of injury unit, do not have access to occupational therapy services and will undergo 'care as usual' in line with the services' protocols and procedures. Care as usual involves standard nursing and medical care and may include: wound care, use of 'off the shelf' orthosis, education, and onward referral to other healthcare professionals.

Other: Care as usual

Interventions

Types of interventions provided by the therapist will include splinting, targeted exercises and activities, occupation-based intervention, edema management, scar management; desensitisation, functional tasks completion, and education. All interventions provided are within occupational therapists' scope of practice and are evidence based. Number of treatment sessions will be individualised to the patient and guided by stages of recovery.

Intervention Group

Care as usual group: Participants attending an emergency department of injury unit, do not have access to occupational therapy services and will undergo 'care as usual' in line with the services\' protocols and procedures. Care as usual involves standard nursing and medical care and may include: wound care, use of 'off the shelf' orthosis, education, and onward referral to other healthcare professionals.

Care as Usual Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged 18 years of age and older attending acutely with a hand injury or condition.

You may qualify if:

  • Adults aged 18 years of age and older
  • Adults presenting with an injury and/ or condition of their hand and/or forearm inhibiting function inclusive of: fractures (proximal, middle, and distal phalanx); tendon and soft tissue injury (PIPJ volar plate, central slip +/- lateral band, mallet injury, trigger finger, flexor injury, extensor injury, thumb tendon and ligament injury); digital nerve injury; or carpal tunnel injury.

You may not qualify if:

  • Patients under 18 years of age
  • Patients presenting with complex medical issues in conjunction with a hand injury who may require an alternative pathway, for example, transfer to a different hospital, requiring prioritisation of another medical emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beaumont Hospital

Dublin, Ireland

RECRUITING

Tallaght University Hospital

Dublin, Ireland

NOT YET RECRUITING

Galway University Hospital

Galway, Ireland

NOT YET RECRUITING

Ennis General Hospital - ULHG

Limerick, Ireland

RECRUITING

Nenagh General Hospital ULHG

Tipperary, Ireland

RECRUITING

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Damien Ryan

    University of Limerick

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann-Marie Morrissey, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

May 6, 2024

Study Start

January 11, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations