Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-02-24
2025-04-30
Brief Summary
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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.
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
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
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
Standard Care
Standard care received at usual NHS facility
Standard Care
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
Standard Care
Standard care received at usual NHS facility
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Northern Care Alliance NHS Foundation Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B01762
Identifier Type: -
Identifier Source: org_study_id
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