Pragmatic Prospective, Multicentre Feasibility Non-randomised Controlled Trial on Enhanced Rehabilitation for Poly & Lower Extremity Trauma (PROPERLY Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Recruitment & retention into both arms of the trial
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Enhanced Rehabilitation Programme (Procedure)
Standard Care
Standard care received at usual NHS facility
干预措施: Standard Care (Procedure)
结局指标
主要结局
Recruitment & retention into both arms of the trial
时间窗: 12 months
Number of patients recruited to ERP
次要结局
- Pain score(baseline, 3, 6 months and 12 months)
- EQ-5D-L(baseline, 3, 6 months and 12 months.)
- PHQ9(baseline, 3, 6 months and 12 months)
- Y Balance test(baseline, 3, 6 months and 12 months)
- ABCS(baseline, 3, 6 months and 12 months)
- Participant and Practitioner experience(Baseline and 6 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)
- 30SSTS(baseline, 3, 6 months and 12 months)