Enhanced Rehabilitation After Major Trauma (PROPERLY)

NCT ID: NCT05652790

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Major Trauma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pragmatic Prospective, multicentre feasibility non-randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Enhanced Rehabilitation Programme

Intervention Type 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

Standard Care

Standard care received at usual NHS facility

Group Type OTHER

Standard Care

Intervention Type PROCEDURE

Standard care received at usual NHS facility

Interventions

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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

Intervention Type PROCEDURE

Standard Care

Standard care received at usual NHS facility

Intervention Type PROCEDURE

Other Intervention Names

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ERP SC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wong, MD

Role: STUDY_CHAIR

National Health Service, United Kingdom

Locations

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Manchester University NHS Foundation Trust - St Mary's

Manchester, Greater Manchester, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Justine Theaker, PhD

Role: CONTACT

0161 276 6845

Jason Wong, MD

Role: CONTACT

Facility Contacts

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Jason Wong

Role: primary

Justine Theaker

Role: backup

Other Identifiers

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B01762

Identifier Type: -

Identifier Source: org_study_id

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