Enhanced Rehabilitation After Major Trauma (PROPERLY) (NCT05652790) | Clinical Trial Compass
CompletedNot Applicable
Enhanced Rehabilitation After Major Trauma (PROPERLY)
United Kingdom55 participantsStarted 2023-02-24
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment & retention into both arms of the trial