Enhanced rehabilitation program for patients recovering from major trauma
Pragmatic Prospective, Multicentre Feasibility Non-randomised Controlled Trial on Enhanced Rehabilitation for Poly & Lower Extremity Trauma (PROPERLY Trial)
This study is testing a new rehabilitation program for people recovering from major trauma to see if it helps them recover better compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT05652790 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of recruiting patients who have survived major trauma for an enhanced rehabilitation service. Participants will be offered the Enhanced Rehabilitation Programme (ERP), which includes two sessions per week lasting 60-120 minutes, and will undergo various functional assessments and patient-reported outcome measures at different intervals. Additionally, a Standard Care (SC) group will be included for comparison, providing data on usual therapy outcomes. The study will identify barriers to recruitment and service delivery, as well as appropriate outcome measures for future larger trials.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with polytrauma or severe isolated injuries, residing in Greater Manchester, and willing to engage in the enhanced rehabilitation program.
Not a fit: Patients under 18 years old or those unable to participate in the rehabilitation program due to health or logistical reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients recovering from major trauma.
How similar studies have performed: While similar rehabilitation approaches have been explored, this specific enhanced program is novel in its focus on major trauma recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust - St Mary's — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Justine Theaker, PhD
- Email: justine.theaker@mft.nhs.uk
- Phone: 0161 276 6845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.