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Enhanced Rehabilitation After Major Trauma (PROPERLY) (PROPERLY)

Primary Purpose

Major Trauma

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Enhanced Rehabilitation Programme
Standard Care
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Manchester University NHS Foundation Trust - St Mary'sRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Enhanced Rehabilitation Programme (ERP)

Standard Care

Arm Description

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

Standard care received at usual NHS facility

Outcomes

Primary Outcome Measures

Recruitment & retention into both arms of the trial
Number of patients recruited to ERP

Secondary Outcome Measures

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.
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
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.
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.
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
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.
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.
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)
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
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

Full Information

First Posted
November 25, 2022
Last Updated
April 24, 2023
Sponsor
Manchester University NHS Foundation Trust
Collaborators
Northern Care Alliance NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05652790
Brief Title
Enhanced Rehabilitation After Major Trauma (PROPERLY)
Acronym
PROPERLY
Official Title
Pragmatic Prospective, Multicentre Feasibility Non-randomised Controlled Trial on Enhanced Rehabilitation for Poly & Lower Extremity Trauma (PROPERLY Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
Northern Care Alliance NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic Prospective, multicentre feasibility non-randomised controlled trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Rehabilitation Programme (ERP)
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care
Arm Type
Other
Arm Description
Standard care received at usual NHS facility
Intervention Type
Procedure
Intervention Name(s)
Enhanced Rehabilitation Programme
Other Intervention Name(s)
ERP
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard Care
Other Intervention Name(s)
SC
Intervention Description
Standard care received at usual NHS facility
Primary Outcome Measure Information:
Title
Recruitment & retention into both arms of the trial
Description
Number of patients recruited to ERP
Time Frame
12 months
Secondary Outcome Measure Information:
Title
EQ-5D-L
Description
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.
Time Frame
baseline, 3, 6 months and 12 months.
Title
PHQ9
Description
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
Time Frame
baseline, 3, 6 months and 12 months
Title
GAD7
Description
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.
Time Frame
baseline, 3, 6 months and 12 months
Title
LEFS
Description
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.
Time Frame
baseline, 3, 6 months and 12 months
Title
Two-minute walk test
Description
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
Time Frame
baseline, 3, 6 months and 12 months
Title
30SSTS
Description
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.
Time Frame
baseline, 3, 6 months and 12 months
Title
Y Balance test
Description
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.
Time Frame
baseline, 3, 6 months and 12 months
Title
Pain score
Description
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)
Time Frame
baseline, 3, 6 months and 12 months
Title
ABCS
Description
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
Time Frame
baseline, 3, 6 months and 12 months
Title
Participant and Practitioner experience
Description
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
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justine Theaker, PhD
Phone
0161 276 6845
Email
justine.theaker@mft.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Wong, MD
Email
jason.wong@mft.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Wong, MD
Organizational Affiliation
National Health Service, United Kingdom
Official's Role
Study Chair
Facility Information:
Facility Name
Manchester University NHS Foundation Trust - St Mary's
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wong
Email
jason.wong@mft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Justine Theaker
Email
justine.theaker@cmft.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan

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Enhanced Rehabilitation After Major Trauma (PROPERLY)

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