Clinical trial NCT05652790: Enhanced Rehabilitation After Major Trauma (PROPERLY)
Official title: Pragmatic Prospective, Multicentre Feasibility Non-randomised Controlled Trial on Enhanced Rehabilitation for Poly & Lower Extremity Trauma (PROPERLY Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Trauma
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Northern Care Alliance NHS Foundation Trust
First posted: 2022-12-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic Prospective, multicentre feasibility non-randomised controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Recruitment & retention into both arms of the trial
timeFrame: 12 months
Secondary outcomes:
measure: EQ-5D-L
timeFrame: baseline, 3, 6 months and 12 months.
measure: PHQ9
timeFrame: baseline, 3, 6 months and 12 months
measure: GAD7
timeFrame: baseline, 3, 6 months and 12 months
measure: LEFS
timeFrame: baseline, 3, 6 months and 12 months
measure: Two-minute walk test
timeFrame: baseline, 3, 6 months and 12 months
measure: 30SSTS
timeFrame: baseline, 3, 6 months and 12 months
measure: Y Balance test
timeFrame: baseline, 3, 6 months and 12 months
measure: Pain score
timeFrame: baseline, 3, 6 months and 12 months
measure: ABCS
timeFrame: baseline, 3, 6 months and 12 months
measure: Participant and Practitioner experience
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust - St Mary's
state: Greater Manchester
Study officials:
affiliation: National Health Service, United Kingdom
name: Jason Wong, MD
role: STUDY_CHAIR
References: