ClinicalTrials.gg
RecruitingNCT06399614Updated Oct 1, 2025

Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition

An observational study in Hand Injuries, sponsored by University of Limerick. Recruiting at 5 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by University of Limerick · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Traumatic hand injuries account for up to one third of acute hospital presentations. The establishment of Occupational Therapy-led hand therapy clinics is gaining momentum within the literature as improving hand trauma patient care and outcomes. It is identified within the literature that point of acute contact service areas such as accident and emergency or injury unit type settings could benefit from a hand therapy service. The benefits reported include: better patient outcomes, reduced waiting times, reduction of patient presentations to consultant led clinics, faster turnaround of patient care and discharge, reduction of patient complaints, improved patient satisfaction, and reduced costs to the health service.

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. Study objectives include:

  1. To define the demographics and characteristics (including functional ability, pain level, and quality of life) of adult service users pre- and post-acute attendance with a hand condition.
  2. To profile clinical and process outcomes after initial visit, at 8-week and 6-month follow-up for patients provided with care as usual and those with targeted hand therapy led assessments and interventions.
  3. To explore any objective and subjective patient, organizational, and societal benefits of hands service provision.

It is hoped the current proposed study will improve the quality, safety, timeliness and cost of care provided to adults who present to acute services with a hand condition. This information may help shape future service development for those with hand injury including provision of evidence based occupational therapy-led services.

02

Conditions studied

  • Hand Injuries

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Keywords

  • Hand injury
  • Hand conditions
  • Occupational Therapy
03

In context

Hand Injuries

122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.

This study's planned enrollment of 150 is above the median of 79 across 22 observational studies indexed under Hand Injuries.

Browse Hand Injuries studies →

Lead sponsor

University of Limerick is the lead sponsor of 60 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Other exclusions at the discretion of the service depending on team capacity and expertise
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherOccupational Therapy-led Hand Therapy Service

    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.

  • OtherCare as usual

    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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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 used to examine health related quality of life outcomes for patients. This is a standardised measure of health status developed by the EuroQoL group to provide a descriptive profile and an index value for health status. A visual analogue scale reporting respondents self-rated health on a vertical visual analogue scale from 'best imaginable health state' (100) to 'worst imaginable health state' (0) is used to capture self reported change in health related quality of life over time. The visual scale represents the patients perspective and is conceptually different from the index system where a value is attached to a ED-5D-5L profile according to a set of weights that reflect average perspectives on health state.

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

  2. 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 used to examine health related quality of life outcomes for patients. This is a standardised measure of health status developed by the EuroQoL group to provide a descriptive profile and an index value for health status. A descriptive system with five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression is completed. This part of the outcome tool can be used to generate a health state profile. Each health state can be assigned an index score and analysed against Irish norms. This helps better understand patients health state in relation to each of the five domains as well as being useful for health economic analysis.

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

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

    The Occupational Self Assessment - Short Form (OSA-SF) is a validated measure designed to assess one's perceived occupational competence and value, as well as supporting the client by informing goal setting and treatment planning. A higher score denotes higher competence and higher value with performance of occupations, with a maximum score of 48 in the 'competence' subset and 36 in the 'value' subset

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

  4. Pain reported by those with acutely presenting hand conditions.

    A pain verbal rating scale (VRS) will be used to measure pain experience, as rated by the patient with '0' indicating no pain, and '10' indicating worst imaginable pain

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

07

Study locations

3 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Nov 2025, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2024
First posted
May 6, 2024
StartActual
Jan 11, 2024
Primary completionEst.
Nov 2025
CompletionEst.
Nov 2025
Last update
Oct 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06399614
Lead sponsor
University of Limerick
Responsible party
Sponsor
First posted
May 6, 2024
Start date
Jan 11, 2024
Primary completion
Nov 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Oct 1, 2025

Study contacts

Margo Sheerin
Contact
margo.sheerin@hse.ie
086 6011586
Ann-Marie Morrissey, PhD
Contact
AnnMarie.Morrissey@ul.ie
086 6011586
Damien Ryan
principal investigator · University of Limerick

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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