Rex Robot Assisted Rehabilitation Exercise to Enhance Balance, Mobility and Upper Limb Function in People With Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Completion of trial sessions
研究概览
简要总结
Title Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted rehabilitation exercise to enhance balance, mobility and upper limb function in people with Multiple Sclerosis "RAPPER III - MS Objective The objective of this study is to evaluate the feasibility and safety of the REX Robot when used for rehabilitation with people who have moderate to severe mobility restrictions due to MS. A secondary objective of the study is to explore the acceptability of the device to people with MS and its impact on impairments and functions commonly affected by MS.
Study Sponsor Rex Bionics, Plc. Study Device REX Robotic powered exercise system Primary Endpoint • Completion of a transfer, stand, balance and walk rehabilitation session.
- Unexpected Serious Adverse Events Secondary Endpoints
- Completion of a transfer, stand, balance and walk rehabilitation program over Six-weeks
- The Number of approached, screened, and eligible potential participants. Reasons for Ineligibility. (See 'RAPPER III- MS 007 Screening Loss Analysis REV 0 FINAL')
- Functional Ambulation Classification (FAC) 1
- Activities-specific Balance Confidence (ABC) Scale 2
- Modified Falls Efficacy Scale (MFES) 3, 4,
- Multiple Sclerosis Walking scale (MSWS-12) 5
- Multiple Sclerosis Impact scale (MSIS-29) 6
- ARMA (arm activity measure) 7
- Berg Balance Scale 8
- Timed unsupported steady stand (TUSS) 9
- Pain scale questionnaire (Visual Analog Score VAS) 10
- Modified Ashworth Score 11
- Spasticity Impact Scale 12
- Epworth Sleepiness Scale (ESS) questionnaire 13
- EQ-5D Health State Questionnaire 14
Questionnaires may be administered in person, by phone, email or in the post.
详细描述
Participant Information Sheet Study title: Rex robot Assisted rehabilitation exercise to enhance balance, mobility and uPPER limb function in people with Multiple Sclerosis "RAPPER III - MS"
Rex Bionics are now enrolling for RAPPER III, a 10 patient trial at East Kent University Hospital foundation Trust.
The study will take place at the following address:
School Of Engineering and Arts, Jennison Building, University of Kent, Canterbury CT2 7NT We would like to invite you to take part in our research study. Before you decide we would like you to understand why the research is being done and what it would involve for you. One of our team will go through the information sheet with you and answer any questions you have.
The objective of this feasibility study is to evaluate the overall device safety when used in a Clinical Rehabilitation Centre under the supervision of a physician and/or qualified rehabilitation specialist. The trial can be completed by patients over 6 sessions, each a week apart. The study will consist of walking in REX Bionics powered exercise device and completing a variety of therapy exercises the assistance of REX trained therapists. You will be asked to complete some questionnaires and other tests before the first session, after the 3rd session and finally after your 6th session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of MS by a Consultant Neurologist as per Mc Donald Criteria. Have moderate to severe mobility restriction as defined by an Extended Disability Status Scale (EDSS) score of between 6 to 7.5 (inclusive). Meet the anthropometric requirements of the REX device (See 'RAPPER IIIMS 014 TF-04 v 3.0 REX Clinical Assessment Guide A4' for details of weight, height, size and range of motion requirements) Offer written informed consent to take part in the study
排除标准
- •a history of osteoporosis or osteoporosis related bone fractures. skin integrity issues that could be adversely affected by the REX device severe hypertonia (spasticity) as indicated by a score equal to or greater than 4 on the modified Ashworth scale on any muscle in their lower limbs. a behavioural, cognitive or communication impairment which could interfere with the ability to participate in a rehabilitation programme, as noted during screening (e.g., agitation, inability to follow two step commands) Are unable or unwilling to provide informed consent Are considered medically unsuitable for rehabilitation in the opinion of the screening medical specialist a known allergy (skin contact) to materials used in Rex Are pregnant
结局指标
主要结局
Completion of trial sessions
时间窗: 6 sessions in total
Completion of all 6 trial sessions noted and recorded in records
Completion of 1 timed 3 metre walk in device (Timed Up & Go Test)
时间窗: First trial session
Participant completes timed walk as above with assistance and guidance from therapist
Completion and time taken for participant transfer into Rex device
时间窗: First trial session
Timed transfer into device (seconds)
Completion of sit to stand in Rex device by participant
时间窗: First trial session
Participant inside Rex device with device switched on moves from sit to stand with supervision of therapist
次要结局
未报告次要终点