Enhanced Rehabilitation After Major Trauma (PROPERLY) (PROPERLY)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Major Trauma
• Intervention / Treatment: Procedure: Enhanced Rehabilitation Programme; Procedure: Standard Care

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Theaker, PhD; Phone Number: 0161 276 6845; Email: justine.theaker@mft.nhs.uk
• Study Contact Backup: Name: Jason Wong, MD; Email: jason.wong@mft.nhs.uk

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9WL
      • Recruiting
      • Manchester University NHS Foundation Trust - St Mary's
      • Contact: Jason Wong; Email: jason.wong@mft.nhs.uk
      • Contact: Justine Theaker; Email: justine.theaker@cmft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Rehabilitation Programme (ERP); 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	Procedure: Enhanced Rehabilitation Programme; 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; Other Names: ERP
Other: Standard Care; Standard care received at usual NHS facility	Procedure: Standard Care; Standard care received at usual NHS facility; Other Names: SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment & retention into both arms of the trial	Number of patients recruited to ERP	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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	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.	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.	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)	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	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	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Northern Care Alliance NHS Foundation Trust
• Investigators: Study Chair: Jason Wong, MD, National Health Service, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: B01762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No