Enhanced Rehabilitation After Major Trauma (PROPERLY)

NCT05652790 | Recruiting DMC

• 1 other identifier: B01762
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Trauma

Outcome Measures

Primary Outcomes (1)

• Recruitment & retention into both arms of the trial

  Number of patients recruited to ERP

  12 months

Secondary Outcomes (10)

• EQ-5D-L

  baseline, 3, 6 months and 12 months.

• PHQ9

  baseline, 3, 6 months and 12 months

• GAD7

  baseline, 3, 6 months and 12 months

• LEFS

  baseline, 3, 6 months and 12 months

• Two-minute walk test

  baseline, 3, 6 months and 12 months

Study Arms (2)

Enhanced Rehabilitation Programme (ERP)

EXPERIMENTAL

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

Standard Care

OTHER

Standard care received at usual NHS facility

Procedure: Standard Care

Interventions

Enhanced Rehabilitation Programme PROCEDURE

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

Also known as: ERP

Enhanced Rehabilitation Programme (ERP)

Standard Care PROCEDURE

Standard care received at usual NHS facility

Also known as: SC

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Northern Care Alliance NHS Foundation Trust: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust - St Mary's

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jason Wong, MD

  National Health Service, United Kingdom

  STUDY CHAIR

Central Study Contacts

Justine Theaker, PhD

CONTACT

0161 276 6845; justine.theaker@mft.nhs.uk

Jason Wong, MD

CONTACT

jason.wong@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pragmatic Prospective, multicentre feasibility non-randomised controlled trial

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 15, 2022
• Study Start: February 24, 2023
• Primary Completion: August 1, 2024
• Study Completion: April 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)