Major TraumaPROPERLYNCT05652790
Enhanced Rehabilitation After Major Trauma (PROPERLY)
A study testing Enhanced Rehabilitation Programme in people with Major Trauma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this study is to assess the feasibility of recruitment, and barriers to delivery of an enhanced rehabilitation service, in patients surviving major trauma. The main questions it aims to answer are: are the investigators able to recruit patients to a research study are the investigators able to retain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Trauma
- What is being tested?
- Enhanced Rehabilitation Programme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Participants over 18 years old
- Registered GP in Greater Manchester or Greater Manchester Resident.
- Polytrauma or one or more complex /severe isolated injury
- Rehabilitation goals (e.g., mobility, function, job retention/ return to work) identified using shared decision-making process
- Patient able to enter programme 6-30 months post injury.
- For the ERP patients willing to travel to the MIHP for their evaluation and treatment twice a week.
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- Participants with lower limb injuries that continue to have functional impairment.
- Participants deemed well and safe enough to participate by clinical teams.
- Normal ECG if previously reported to have abnormal ECG
- Participants willing to consent to follow up over 12 months
- Participants with the capacity to consent to the study.
- Fully healed wounds and bone healed sufficiently to allow at least partial weight bearing
Who cannot join
- Participants under the age of 18
- Participants unable to provide informed consent
- Participants with multiple pre-existing comorbidities that affect ability to participate in enhanced rehabilitation such as cognitive impairment, unstable angina.
- Central motor neurological impairment affecting ability to participate in an enhanced rehab programme
- Absence of functional disability affecting gait and / or function.
- Plans for further surgery that will impact on gait or function.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust - St Mary's
Manchester, Greater Manchester, M13 9WL
About this study
Official title: Pragmatic Prospective, Multicentre Feasibility Non-randomised Controlled Trial on Enhanced Rehabilitation for Poly & Lower Extremity Trauma (PROPERLY Trial)
The goal of this study is to assess the feasibility of recruitment, and barriers to delivery of an enhanced rehabilitation service, in patients surviving major trauma.
The main questions it aims to answer are:
Read more
are the investigators able to recruit patients to a research study are the investigators able to retain patients in the research study are the investigators able to identify appropriate primary outcome measures are the investigators able to identify barriers to future large-scale definitive trial or service delivery Participants will would be offered at least two sessions of the Enhanced Rehabilitation Programme (ERP), each lasting 60-120 minutes per week, delivered in the Manchester Institute of Health and Performance (MIHP).
Participants not willing to travel to the MIHP, or declining to engage in the ERP, will be asked to join the Standard Care (SC) group. This group will provide questionnaire data and clinical outcome measure collection with their usual place of therapy.
Researchers will compare the ERP group and the SC groups to assess any additional benefits to the ERP.
Read the detailed description
The investigators will aim to recruit 25 participants for the ERP and 25 participants in SC (50 in total) who will go through a series of quantitative functional assessments and patient reported outcome measures, at baseline (at the beginning of the programme), middle (3 months), on discharge from the programme (usually 6 months). If patients are discharged earlier, assessments will be performed at the discharge visit.
Assessments using PROMS will be conducted at baseline (at the beginning of the programme), middle (3 months), on discharge from the programme (usually 6 months), and 12 months.
- Conditions
- Major Trauma
- Being tested
- Enhanced Rehabilitation Programme, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Rehabilitation ProgrammeProcedure or surgery
Also called ERP
The ERP would be offered at least two sessions, each lasting 60-120 minutes per week, delivered in the Manchester Institute of Health and Performance. Interventions may include a combination of the following depending on the individual patient needs.
Manual Therapy Hydrotherapy Exercise Strength and Conditioning Programmes Gait re-education Pilates/ Yoga Cognitive and Vocational Rehabilitation Occupation Therapy Interventions eg. Anxiety Management, Pacing, Cognitive Behavioural Therapy
Standard CareProcedure or surgery
Also called SC
Standard care received at usual NHS facility
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Rehabilitation Programme (ERP) | Experimental | 60-120 MINUTES OF ENHANCED REHABILITATION
Manual Therapy Hydrotherapy Exercise Strength and Conditioning Programmes Gait re-education Pilates/ Yoga Cognitive and Vocational Rehabilitation Occupation Therapy Interventions eg. Anxiety Management, Pacing, Cognitive Behavioural Therapy Receives: Procedure: Enhanced Rehabilitation Programme |
| Standard Care | Other | Standard care received at usual NHS facility Receives: Procedure: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment & retention into both arms of the trial
Number of patients recruited to ERP
Measured: 12 months
Secondary outcomes (10)
EQ-5D-L
Functional impairment outcome measure
The lowest score of 0 indicates no functional impairment and a score of 4 indicates significant impairment. The category responses are not combined.
Using a continuous scale on a 20cm vertical visual analogue scale (VAS) a score of 100 means 'the best health imaginable and a score of 0 means 'the worst health imaginable.' EQ5DL Scores at different timepoints are compared to show changes in health over time.
Measured: baseline, 3, 6 months and 12 months.
PHQ9
Patient Health Questionnaire 9 The Patient Health Questionnaire-9 (PHQ-9) is a brief psychological screening instrument designed to measure symptoms of depression in healthcare settings.
It contains 9 questions that help identify patients with clinically meaningful symptoms of depression. Patient responses are scored 0-3 with 0 representing "not at all" and 3 indicating "nearly every day;" thus, the PHQ-9 contains a total score range of 0-27
Measured: baseline, 3, 6 months and 12 months
GAD7
General Anxiety and Depression Score 7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measured: baseline, 3, 6 months and 12 months
LEFS
Lower Extremity Functional Scale (LEFS) determines functional status in patients suffering from lower extremity disorders and disabilities.
This health tool evaluates the ability of the subject to perform daily activities. It comprises of a list of 20 everyday tasks and is used by clinicians as a measure of functional status and in setting goals and monitoring progress in different conditions. Participants rate the level of difficulty as follows
- Extreme difficulty or unable to perform activity (0 points);
- Quite a bit of difficulty (1 point);
- Moderate difficulty (2 points);
- A little bit of difficulty (3 points);
- No difficulty (4 points);
The maximum score obtainable is 80 points which signifies complete function and the lowest score is 0 which indicates very low function. All LEFS scores are then awarded as number of points out of the total of 80.
Measured: baseline, 3, 6 months and 12 months
Two-minute walk test
the Two-minute walk test is a simple functional test that evaluates submaximal exercise, test used to assess aerobic capacity and endurance. The distance covered over a time of 2 minutes is used as the outcome by which to compare changes in performance capacity
Measured: baseline, 3, 6 months and 12 months
30SSTS
30 Second sit to stand test
30 Second Sit to Stand Test (also known as 30 second chair stand test - 30CST), is for testing leg strength and endurance (Rikli \& Jones 1999), where patients are asked to repeat sitting and standing as quickly as possible without the aid of their arms on a standardised seat. The total number of completed Sit to Stands is recorded as the measure.
Measured: baseline, 3, 6 months and 12 months
Y Balance test
The Lower Quarter Y Balance Test (LQYBT) is a tool used to test a person's risk for injury by evaluating balance, gait stability and strength.
Patients stand on one leg while reaching out in 3 different directions with the other lower extremity, the 3 reaches yield a "composite reach distance" or composite score used to predict injury.
Measured: baseline, 3, 6 months and 12 months
Pain score
A Numerical Pain Rating Scale (NRS) will be used to assess patients pain throughout the programme. (0-100)
- 0 is worse pain 100 is no pain (Jensen et al, 1995)
Measured: baseline, 3, 6 months and 12 months
ABCS
Activities Specific Balance Confidence Scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness.
The ABCS is a 16-item questionnaire where patients' rate their confidence while doing activities.
Scoring from 0-100 (0 is no confidence and 100 is full confidence)
Lower than 50 %: low level of physical functioning 50-80 %: moderate level of physical functioning Above 80 %: high level of physical functioning
Measured: baseline, 3, 6 months and 12 months
Participant and Practitioner experience
Participant and Practitioner interviews to evaluate
- Participants with multiple pre-existing comorbidities that affect ability to participate in enhanced rehabilitation such as cognitive impairment, unstable angina, foot ulcers, inflammatory arthritis, injury
- Central neurological impairment
- Absence of functional disability affecting gait.
- Awaiting further surgery that will affect function
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start24 Feb 2023
- Primary completion1 Apr 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major TraumaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic Prospective, multicentre feasibility non-randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jason Wong, MD, Study chair, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652790
- Sponsor's protocol ID
- B01762
- Acronym
- PROPERLY
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Prospective, Multicentre Feasibility Non-randomised Controlled Trial on Enhanced Rehabilitation for Poly & Lower Extremity Trauma (PROPERLY Trial)
- ClinicalTrials.gov ID
- NCT05652790
- Acronym / sponsor ID
- PROPERLY / B01762
- Conditions
- Major Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 15 Dec 2022 (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.
The goal of this study is to assess the feasibility of recruitment, and barriers to delivery of an enhanced rehabilitation service, in patients surviving major trauma.
The main questions it aims to answer are:
are the investigators able to recruit patients to a research study are the investigators able to retain patients in the research study are the investigators able to identify appropriate primary outcome measures are the investigators able to identify barriers to future large-scale definitive trial or service delivery Participants will would be offered at least two sessions of the Enhanced Rehabilitation Programme (ERP), each lasting 60-120 minutes per week, delivered in the Manchester Institute of Health and Performance (MIHP).
Participants not willing to travel to the MIHP, or declining to engage in the ERP, will be asked to join the Standard Care (SC) group. This group will provide questionnaire data and clinical outcome measure collection with their usual place of therapy.
Researchers will compare the ERP group and the SC groups to assess any additional benefits to the ERP.
Detailed description
The investigators will aim to recruit 25 participants for the ERP and 25 participants in SC (50 in total) who will go through a series of quantitative functional assessments and patient reported outcome measures, at baseline (at the beginning of the programme), middle (3 months), on discharge from the programme (usually 6 months). If patients are discharged earlier, assessments will be performed at the discharge visit.
Assessments using PROMS will be conducted at baseline (at the beginning of the programme), middle (3 months), on discharge from the programme (usually 6 months), and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Prospective, multicentre feasibility non-randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced Rehabilitation Programme (ERP) | Experimental | Procedure: Enhanced Rehabilitation Programme60-120 MINUTES OF ENHANCED REHABILITATION Manual Therapy Hydrotherapy Exercise Strength and Conditioning Programmes Gait re-education Pilates/ Yoga Cognitive and Vocational Rehabilitation Occupation Therapy Interventions eg. Anxiety Management, Pacing, Cognitive Behavioural Therapy |
| Standard Care | Other | Procedure: Standard CareStandard care received at usual NHS facility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants over 18 years old
- Registered GP in Greater Manchester or Greater Manchester Resident.
- Polytrauma or one or more complex /severe isolated injury
- Rehabilitation goals (e.g., mobility, function, job retention/ return to work) identified using shared decision-making process
- Patient able to enter programme 6-30 months post injury.
Key exclusion criteria (6 listed)
- Participants under the age of 18
- Participants unable to provide informed consent
- Participants with multiple pre-existing comorbidities that affect ability to participate in enhanced rehabilitation such as cognitive impairment, unstable angina.
- Central motor neurological impairment affecting ability to participate in an enhanced rehab programme
- Absence of functional disability affecting gait and / or function.
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 |
|---|---|---|
| Enhanced Rehabilitation ProgrammeAlso: ERPThe ERP would be offered at least two sessions, each lasting 60-120 minutes per week, delivered in the Manchester Institute of Health and Performance. Interventions may include a combination of the following depending on the individual patient needs. Manual Therapy Hydrotherapy Exercise Strength and Conditioning Programmes Gait re-education Pilates/ Yoga Cognitive and Vocational Rehabilitation Occupation Therapy Interventions eg. Anxiety Management, Pacing, Cognitive Behavioural Therapy | Procedure or surgery | Enhanced Rehabilitation Programme (ERP) |
| Standard CareAlso: SCStandard care received at usual NHS facility | Procedure or surgery | Standard Care |
Primary outcome
Recruitment & retention into both arms of the trial
Time frame: 12 months
Number of patients recruited to ERP
10 secondary outcomes
EQ-5D-L
Time frame: baseline, 3, 6 months and 12 months.
PHQ9
Time frame: baseline, 3, 6 months and 12 months
GAD7
Time frame: baseline, 3, 6 months and 12 months
LEFS
Time frame: baseline, 3, 6 months and 12 months
Two-minute walk test
Time frame: baseline, 3, 6 months and 12 months
30SSTS
Time frame: baseline, 3, 6 months and 12 months
Y Balance test
Time frame: baseline, 3, 6 months and 12 months
Pain score
Time frame: baseline, 3, 6 months and 12 months
ABCS
Time frame: baseline, 3, 6 months and 12 months
Participant and Practitioner experience
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No. no plan
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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. This study is not recruiting at the moment.
Jason Wong, MD study chair
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Rehabilitation Programme in people with Major Trauma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 12 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment & retention into both arms of the trial (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.