Innovative Physiotherapy and Coordination of Care for People With Multiple Sclerosis: a Randomised Controlled Trial and a Qualitative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Measure a change in the outcome: Mini-Balance Evaluation Systems Test
研究概览
简要总结
This project comprises a two-arm randomized controlled trial (RCT) complemented by qualitative research on innovative group-based intervention for people with Multiple Sclerosis (MS) performed in the primary health care and organized in collaboration with the services provided by a hospital's outpatient clinic. The RCT will be conducted by Nordland Hospital Trust, Bodø (NLSH), in collaboration with UiT The Arctic University of Norway (UiT) and the Norwegian Centre for Integrated Care and Telemedicine, University Hospital North Norway (NST). The overall purpose of the RCT is to demonstrate whether high-intensity individualised group-based core stability training (GroupCoreSIT) performed by physiotherapists (PTs) in the primary health care has effect on balance, walking and activities of daily living (ADL) in people with MS compared to standard care. Changes in quality of life and costs will also be studied to conclude whether the intervention is cost-effective. The qualitative study contains three parts. The first part aims to investigate users' experiences from participating in the new group intervention and in standard care. The researchers will particularly focus on reflections regarding content, feasibility, potential changes in ADL, self-management, and continuity of care. The second part will investigate how the PTs act and interact with the group while conducting the intervention, particularly how individualization is carried out, and the PTs' reflections from participating in the education and performance of the intervention. The third part explores health professionals' reflections regarding coordination of care in people with MS.
详细描述
This research project first aims to compare the effects of high-intensity individualized group-based core stability training (GroupCoreSIT) for people with MS with standard care in the primary health care focusing on balance, walking, ADL, quality of life and cost-effectiveness. Secondly, the project aims to investigate patients' experiences from participating in the intervention and in standard care, particularly addressing reflections regarding content, relevance and feasibility, changes in ADL, continuity of care, self-management. The third aim is to investigate how the PTs act and interact with the group while conducting the intervention, particularly how individualization is carried out, and the PTs' reflections from participating in the education and performance of the intervention. Finally, changes in patients' pathways and coordination represent another main objective of this project.
The RCT: hypothesis, study outcomes and measures:
High-intensity individualised group-based core stability training performed at the municipal PTs' facilities, complemented by home exercises, will improve balance, walking, ADL, quality of life and cost-effectiveness. This is reflected in the primary and secondary outcomes.
RCT will be conducted in collaboration with the outpatient clinic for people with MS at the Nordland Hospital Trust, Bodø, together with six municipalities in Nordland County. The municipalities are included: Bodø, Rana, Meløy, Rødøy, Vågan and Fauske. The out-patient clinic agreed to recruit the participants by sending a written invitation to people with MS in the selected municipalities, fulfilling the inclusion criteria. Six PTs with expertise in neurological physiotherapy agreed to conduct the intervention. These PTs will attend a four days practical and theoretical training on the intervention, with 1-2 follow up videoconferences during the study.
A prospective RCT will be conducted, in which 72 persons with MS will participate, undergo a 6-week intervention, and be followed up for 6 months. Participants will be randomly assigned to two arms in a 1:1 ratio. Participants in the intervention arm A will be offered individualised group-based core stability training termed GroupCoreSIT at the PTs facilities, complemented with home exercises. Participants in the control arm B will be offered standard care. Significant improvements in outcomes are expected for the intervention arm compared to standard care. Randomisation will be stratified by European Disability Score Scale (EDSS) to minimize selection bias and preserve homogeneity between arms. Randomisation and data collation will be performed using Remote Data Entry (WebCRF), an Internet-based solution developed by the Norwegian University of Science and Technology (NTNU). The researchers aim to recruit all subjects within 5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosis of MS (McDonald's criteria)
- •EDSS 1-6.5 (minimal symptoms - able to walk 20 minimum meter with two crutches)
- •Minimum 14 days post exacerbation
- •Age >18 years
- •Capable to provide signed written informed consent
排除标准
- •Pregnancy at enrolment
- •Acute orthopedic conditions affecting balance and walking
研究组 & 干预措施
GroupCoreSIT
Before the group training starts, the physiotherapist in charge of the group does a clinical assessment of each participant in order to individualise the training. Each training group will consist of three participants. The training sessions will last for 60 minutes, performed three days per week, for six weeks, between 10 am and 5 pm.
干预措施: GroupCoreSIT (Behavioral)
Standard care
The control group receive standard care, which means to follow their ordinary physiotherapy services and/or routines/activities. The content of standard care may vary, and will be recorded for all the participants.
干预措施: Standard care (Behavioral)
结局指标
主要结局
Measure a change in the outcome: Mini-Balance Evaluation Systems Test
时间窗: 6 months post intervention
The outcome measures standing and walking balance
Measure a change in the outcome:Mini-Balance Evaluation Systems Test
时间窗: 3 months post intervention
The outcome measures standing and walking balance
Trunk Impairment Scale modified Norwegian Version
时间窗: Baseline
The outcome measures sitting balance
Measure change in the outcome: Trunk Impairment Scale modified Norwegian Version
时间窗: 3 months post intervention
The outcome measures sitting balance
Measure a change in the outcome: Trunk Impairment Scale modified Norwegian Version
时间窗: 6 months post intervention
The outcome measures sitting balance
Mini-Balance Evaluation Systems Test
时间窗: baseline
The outcome measures standing and walking balance
Measure change in the outcome: Trunk Impairment Scale modified Norwegian Version
时间窗: 1 week post intervention
The outcome measures sitting balance
Measure a change in the outcome: Mini-Balance Evaluation Systems Test
时间窗: 1 week post intervention
The outcome measures standing and walking balance
次要结局
- 10-Meter Walk Test(Baseline)
- Measure a change in the outcome: 10 Meter Walk Test(6 months post intervention)
- Measure a change in the outcome:10 Meter Walk Test(3 months post intervention)
- Rivermead Visual Gait Assessment(Baseline)
- Measure a change in the outcome:Rivermead Visual Gait Assessment(6 months post intervention)
- MS Walking Scale-12(Baseline)
- Measure a change in the outcome:MS Walking Scale-12(3 months post intervention)
- Measure a change in the outcome: MS Walking Scale-12(6 months post intervention)
- Multiple Sclerosis Impact Scale-29(Baseline)
- The Patient Global Impression of Change(1 week post intervention)
- Measure a change in the outcome:Multiple Sclerosis Quality of Life-54 (MSQOL-54)(6 months post intervention)
- Health Questionnaire (EQ-5D-3L)(Baseline)
- Measure a change in the outcome:Health Questionnaire (EQ-5D-3L)(6 months post intervention)
- 2-Minutes Walk Test(Baseline)
- Measure a change in the outcome: 2-Minutes Walk Test(1 week post intervention)
- Measure a change in the outcome:2-MinutesWalk Test(3 months post intervention)
- Measure a change in the outcome:2-Minutes Walk Test(6 months post intervention)
- Measure a change in the outcome:Multiple Sclerosis Impact Scale-29(6 months post intervention)
- Measure a change in the outcome: Patient Global Impression of Change(6 months post intervention)
- ActiGraph activity monitor.(baseline)
- Measure a change in the outcome:ActiGraph activity monitor.(1 week post intervention)
- Measure a change in the outcome:ActiGraph activity monitor(6 months post intervention)
- Multiple Sclerosis Quality of Life-54 (MSQOL-54)(Baseline)
- Measure a change in the outcome: 10 Meter Walk Test(1 week post intervention)
- Measure a change in the outcome:Rivermead Visual Gait Assessment(1 week post intervention)
- Measure a change in the outcome:Rivermead Visual Gait Assessment(3 months post intervention)
- Measure a change in the outcome:Multiple Sclerosis Quality of Life-54 (MSQOL-54)(1 week post intervention)
- Measure a change in the outcome:MS Walking Scale-12(1 week post intervention)
- Measure a change in the outcome:Multiple Sclerosis Impact Scale-29(1 week post intervention)
- Measure a change in the outcome:Multiple Sclerosis Impact Scale-29(3 months post intervention)
- Measure a change in the outcome: Patient Global Impression of Change(3 months post intervention)
- Measure a change in the outcome:ActiGraph activity monitor(3 months post intervention)
- Measure a change in the outcome:Multiple Sclerosis Quality of Life-54 (MSQOL-54)(3 months post intervention)
- Measure a change in the outcome:Health Questionnaire (EQ-5D-3L)(1 week post intervention)
- Measure a change in the outcome:Health Questionnaire (EQ-5D-3L)(3 months post intervention)