Title: Development of a Device for the Motorised Rehabilitation of Walking (MoRoW-3)
Funder: Department of Health and Social Care

Abstract: This work will be arranged in to seven work packages (see also the Milestone Gantt chart in supporting documentation file) Work Package (WP)1 (months 0-24, lead; Butters): Technical Development to finalise the design of the following elements 1a: Electronic control hardware, motors, control software, instrumentation 1b: The harness. 1c: The foot support. 1d: Device frame development and ensure they are functionally fit-for-purpose. That is; &bull; suitable for the full range of body sizes and shapes &bull; supports the patient comfortably &bull; easy for unqualified staff to use &bull; can be donned and doffed easily with a single assistant &bull; complies with infection control and manual handling policies Deliverable= A series of design iterations and prototypes (Month 15) to internally validate the design s functionality with respect to users needs and performance and inform WP2. WP2: Design for Manufacture of the entire product (15 months, months 13-27, lead; Woodcock). All aspects of the WP1 s design will be refined and validated for cost-effective, large scale manufacture (ready for clinical trials with a full technical file to comply with CE regulations. Deliverable= 1. Full CE compliant Product Technical File 2. Four clinic ready MOROW-3 devices (M15) 3. Two cost validated production prototypes (M27). WP3: Consultations with stroke survivors and clinicians (Months 0-27, lead; Tyson): Workshops with our clinical and stroke survivor consultation groups to inform the design of MOROW-3 and the clinical trial Deliverable= Workshop reports with information to ensure MOROW is fit-for-purpose. WP4: Obtain anthropometric data on stroke survivors (12 months, months 0-12, lead; Tyson). Anthropometric data (limb lengths, trunk lengths and widths, height) on the 500 stroke survivors from 10 large NHS large trusts to inform the dimensions, tolerance, adjustability, and fit of MOROW-3 Deliverable= Data to refine the User Requirements Specification WP5: Pilot clinical evaluation (15 months, months 12-27, lead; Tyson). A pilot randomized controlled trial of 4 weeks training of sit-to-stand and walking using MOROW-3 (up to 30 mins/ weekday) compared to usual therapy in 20 stroke survivors who are unable to walk at least one week post-stroke, recruited from two large stroke services in Manchester. Assessments at baseline; four weeks and follow-up (8 weeks after baseline) Primary outcome = independence in sit-to-stand and walking (specific items of the Barthel Index). Secondary Outcomes = &bull; time to independence: Mobility Milestones &bull; quality of movement: biomechanical movement analysis at the University of Salford s gait analysis clinic &bull; motor impairments: strength (Motricity Index); Sensation (RASP); spasticity (modified Ashworth Scale) &bull; adherence and dose of treatment: number of repetitions/ session; length of treatment session; number of treatment sessions &bull; adverse events: self-report &bull; recruitment and retention rates; numbers screened, approached and consented; numbers completing each assessment &bull; feasibility and acceptability of the interventions: staff focus groups and patient interviews Deliverable= clinical proof-of-concept to inform further evaluation of clinical efficacy. WP 6: Commericalisation, Regulatory Compliance and Business Plan (months 0-27 lead; Butters). Working with specialists, we will ensure an informed commercialisation plan is produced that sets out the benefits of MOROW-3 to client organisations and patients. We will create a strategy to support regulatory compliance for the Product Technical File for regulatory approvals. All IP will be protected and managed. Insight gleaned from client, user and clinician engagement will be reflected in the revised business plan. DELIVERABLE= IP protected, CE Product Technical File and business plan produced, regulatory compliance strategy and documentation in place WP7: Project management (months 0-27 lead; Butters). Deliverable= Project is delivered to time, budget and specification with all milestones achieved

Lay abstract: This proposal is to develop a robot (called the Motorised Rehabilitation of Walking; MoRoW-3) to retrain sit-to-stand and walking for people with severe disabilities that is ready for commercial production and clinical trials. This application involves the largest relevant group of potential users; people with stroke, but MOROW-3 is suitable for other clinical groups with a similar degree of disability. The work is divided in to 7 work packages (WP) over 27 months: &bull; WP1: Technical development of the electronic and motor systems, software, body support harness, foot supports, user-interface (the controls and bits that patients or professionals use to make the machine work) and frame &bull; WP2: Design and production of MOROW-3 for cost effective manufacture and maintenance and to validate quality management and commissioning &bull; WP 3: Consultation with stroke survivors and clinicians to ensure MOROW-3 is fit-for-purpose. &bull; WP4: Collection of anthropometric data (length and widths of legs and trunk) from stroke survivors to ensure MOROW-3 accommodates the full range of body shapes and weights &bull; WP5: Pilot randomized controlled trial of MOROW-3 to provide clinical proof-of-concept &bull; WP6: Business plan development including regulatory affairs, intellectual property protection and marketing, pricing and adoption (into the NHS) strategies &bull; WP7: Project management to ensure all milestones achieved on time, specification and budget. The research team are an experienced multi-disciplinary group with a long track record of successful user-led research and commercial development of health related assistive technology. This application builds on a HTD funded project (MOROW-2, HTD497) which was completed on time and budget with outputs exceeding the original specification, (thereby demonstrating our track record). MOROW-2 was patented and led to a spin-off company to produce MOROW commercially (Morow Ltd).

Research activity codes: 5.3 MEDICAL DEVICES;6.3 MEDICAL DEVICES
Health categories: STROKE