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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United Kingdom

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 groups in NCT05652790
Study groupRoleWhat they receive
Enhanced Rehabilitation Programme (ERP)Experimental60-120 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 CareOtherStandard 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.

  1. Recruitment & retention into both arms of the trial

    Number of patients recruited to ERP

    Measured: 12 months

Secondary outcomes (10)
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted15 Dec 2022
  2. Study start24 Feb 2023
  3. Primary completion1 Apr 2025
  4. Study completion31 Jan 2026

Resources

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)
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

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.

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