Hand InjuriesNCT06399614
Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
An observational study of Hand Injuries, run by University of Limerick at 5 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Occupational Therapy-led Hand Therapy Service and Care as usual
- How many people
- 150 participants
- Where
- 5 sitesIreland
- Study dates
- 11 Jan 2024to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years of age and older attending acutely with a hand injury or condition.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Ireland5 sites, 5 recruiting
- Recruiting
Beaumont Hospital
Dublin
Eileen Walsh, 01-797 7520, eileenwalsh@beaumont.ie
- Not yet recruiting
Tallaght University Hospital
Dublin
Simone Derham, 01 4142790, simone.derham@tuh.ie
Margo Sheerin, 0877680504, margo.sheerin@hse.ie
- Not yet recruiting
Galway University Hospital
Galway
Lorna Spellman, 091 542431, Lorna.Spellman@hse.ie
- Recruiting
Ennis General Hospital - ULHG
Limerick
Brenda Bleach, MHSc, 065 6863121, Brenda.bleach@hse.ie
Margo Sheerin, BSc, 0866011586, margo.sheerin@hse.ie
- Recruiting
Nenagh General Hospital ULHG
Tipperary
Margo Sheerin, BSc, 0866011586, margo.sheerin@hse.ie
Damien Ryan, MD, 06731491, Damien.ryan@hse.ie
About this study
Official title: An Evidenced Based Analytical Study of Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
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:
- 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.
- 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.
- 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.
- Conditions
- Hand Injuries
- Being tested
- Occupational Therapy-led Hand Therapy Service, Care as usual
- Keywords
- Hand injury, Hand conditions, Occupational Therapy
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy-led Hand Therapy ServiceOther
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.
Care as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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) 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
Measured: 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.
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
Measured: The pain verbal rating scale will be administered at baseline, at 8-weeks (post intervention), and at six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start11 Jan 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Ryan, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399614
- Sponsor's protocol ID
- ULimerick24
- Status last verified
- Sep 2025
- First submitted
- 27 Mar 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheerin M, Galvin R, Ryan D, Carey L, Fallon E, Bleach B, Spellman L, Derham S, Walsh E, Morrissey AM. The impact of therapy-led hand clinics for the treatment of acute hand injury: A cluster non-randomised controlled trial. Clin Rehabil. 2026 Sep 17:2692155261487461. doi: 10.1177/02692155261487461. Online ahead of print.
PubMed 42752255
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidenced Based Analytical Study of Occupational Therapy-led Services for Adults Presenting Acutely With a Hand Condition
- ClinicalTrials.gov ID
- NCT06399614
- Acronym / sponsor ID
- ULimerick24
- Conditions
- Hand Injuries
- Keywords
- Hand injury, Hand conditions, Occupational Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: Occupational Therapy-led Hand Therapy ServiceParticipants 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. |
| Care as Usual Group | – | Other: Care as usualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years of age and older attending acutely with a hand injury or condition.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Therapy-led Hand Therapy ServiceTypes 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. | Other | Intervention Group |
| Care as usualCare 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 Group |
Primary outcome
Function: our primary outcome is change in patient function for those with acutely presenting hand conditions.
Time frame: The QuickDASH will be administered at baseline, at 8-weeks (post intervention), and at six months.
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.
4 secondary outcomes
Change in health related quality of life for those with acutely presenting hand conditions using a visual scale.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The pain verbal rating scale will be administered at baseline, at 8-weeks (post intervention), and at six months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 42752255Sheerin M, Galvin R, Ryan D, Carey L, Fallon E, Bleach B, Spellman L, Derham S, Walsh E, Morrissey AM. The impact of therapy-led hand clinics for the treatment of acute hand injury: A cluster non-randomised controlled trial. Clin Rehabil. 2026 Sep 17:2692155261487461. doi: 10.1177/02692155261487461. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damien Ryan principal investigator
University of Limerick
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries, run by University of Limerick at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margo Sheerin (086 6011586, margo.sheerin@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function: our primary outcome is change in patient function for those with acutely presenting hand conditions. (time frame: The QuickDASH will be administered at baseline, at 8-weeks (post intervention), and at six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06399614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.