Feasibility Study for a Randomised Control Trial for the Acceptability of Exoskeleton Assisted Walking Compared to Standard Exercise Training for Persons With Mobility Issues Due to Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Acceptability of the intervention - Patient perception questionnaire
研究概览
简要总结
Multiple sclerosis (MS) is a chronic, inflammatory disease of the central nervous system. Lack of physical activity is common in people with MS (pwMS). This can lead to several comorbid conditions such as obesity, metabolic syndrome, osteoporosis, hypertension, diabetes and worse prognosis. An increasing number of studies suggest that physical exercise can play an important role in managing symptoms, preventing complications and comorbidities in pwMS, and may possibly be neuroprotective. However, doing exercise can be very challenging for pwMS who have moderate/severe mobility disability and who have problems with walking.
In this project, the investigators will explore the use of a powered Exoskeleton as an exercise tool for people with moderate to severe difficulty walking due to MS. Powered Exoskeletons are wearable robots that offer opportunity to persons with lower limb weakness to stand and walk. The Exoskeleton-assisted training provides active training with potentially much less intervention needed from therapists. However, it is not clear whether pwMS can walk with a powered Exoskeleton at speeds and intensities sufficient to positively affect health and fitness outcomes. Thus, in this study, the investigators aim to explore whether using an Exoskeleton will enable people with MS to exercise at a moderate intensity and whether people with MS find this acceptable and safe to do on a regular basis. The investigators will also explore whether training with an Exoskeleton can improve walking. The investigators will train 12 patients with MS to walk with an Exoskeleton twice a week for 8 weeks. The investigators will compare the effects with another group of 12 patients who will do exercises with a fitness instructor twice a week for 8 weeks. The investigators will study whether walking with Exoskeleton is better than fitness training in terms of fitness outcomes, walking and cognitive, psychological factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
It is not practical to blind the participants to the intervention as the study team are studying two different types of physical activities. The study team will explore whether it is feasible for the outcome assessor to be blind to the treatment allocation.
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 as per the McDonald criteria (Polman et al., 2011).
- •Age 18 years or older.
- •Cognitive ability to give consent and participate in the protocol.
- •Walking limitations with Expanded Disability Status Scale (EDSS) scores ranging from 5.0 to 7.
- •Enough strength in hands and shoulders to support themselves standing and walking using crutches or a walker.
- •Meet the general requirements to fit with the Phoenix Exoskeleton (160-190.5 cm in height, weight below 80 Kg, hip width no greater than 42.7 cm measured when sitting, healthy skin where it touches Phoenix Exoskeleton).
- •Able to tolerate exercise twice per week as judged by the PI during screening.
排除标准
- •Any illness, other than MS, affecting walking and exercise performance.
- •Severe cognitive or behavioral impairment.
- •Relapses 3 months prior to enrolment.
- •Change in disease modifying drugs for MS 6 months before enrolment.
- •Botulin toxin injections for the lower limbs the previous 3 months.
- •Any medical contraindications to assisted walking (e.g., cardiovascular condition, weight-bearing restrictions, osteoporosis or other fracture risk, pregnancy, uncontrolled seizure).
- •Significant flexion contractures limited to 35 degrees at the hip and 20 degrees at the knee that precluded Phoenix Exoskeleton fit.
- •Psychopathology or other health conditions that the physiotherapist, in his or her clinical judgement, considers to be exclusionary to safely use an Exoskeleton.
- •Living more than 20 miles away from the experiment location to reduce burden on patients due to the number of planned study visits.
研究组 & 干预措施
Standard Exercise Training Programme
Participants will receive interventions by an exercise specialist based on the participant's tolerance. These sessions will be delivered by a exercise specialist.
干预措施: Standard Exercise Training (Behavioral)
Exoskeleton Exercise Programme
The Phoenix Exoskeleton suit will be used in this study. It is a powered Exoskeleton, with a modular design. Participants will receive interventions by an research physiotherapist based on the participant's tolerance.
干预措施: Phoenix Exoskeleton suit (Device)
结局指标
主要结局
Acceptability of the intervention - Patient perception questionnaire
时间窗: 8 weeks
A patient perception questionnaire will be used to gather more in-depth qualitative data about acceptability. This will give us insight into the acceptability of the type of exercise and any benefits that have been derived, helping us to take the project forward in the future and design an intervention that fits with the requirements of this population group.
Recruitment rate estimation
时间窗: One day
The research team will identify the number of potential participants who responded to our initial recruitment strategies and the proportion who remain interested after being informed of the requirements of the study. Feasibility will be classed as 60% or more of eligible participants consenting to the trial.
Retention rate estimation
时间窗: 8 weeks
Adherence will be measured through attendance at the Exoskeleton and exercise sessions and compliance to the protocol. Feasibility will be classed as 75% of the recruited participants completing 12 or more of the 16 intervention sessions (not including the familiarisation sessions). Patient Participation will be assessed by the research physiotherapist and exercise therapist using the Pittsburg Participation Questionnaire.
Acceptability of the intervention - VAS
时间窗: 8 weeks
Data from participant's visual analogue scale of patient discomfort will be used to determine acceptability. Feasibility will be defined as less than 1/3 of participants reporting moderate or greater discomfort on the visual analogue scale. Throughout the study, participants asked to score discomfort experienced on VAS scale 0-10 where 0=no discomfort and 10=intolerable.
次要结局
- Aerobic Fitness (arm cranking)(8 weeks)
- Waist to hip ratio(8 weeks)
- Multiple Sclerosis walking scale (MSWS-12)(8 weeks)
- 10 metre walking gait test wearing inertial sensors(8 weeks)
- Body fat percentages(8 weeks)
- The Borg rating of perceived exertion scale(8 weeks)
- Number of participants achieving target heart rate(8 weeks)
- Multiple Sclerosis Impact Scale (MSIS-29)(8 weeks)
- Modified Fatigue Impact Scale (MFIS)(8 weeks)
- Quality of life questionnaire (EQ-5D-5L & VAS)(8 weeks)