Robot suit HAL The use of exoskeletons in rehabilitation and as assistive technology to enable equal participation Feasibility Study Man Machine Interface Robot Suit MMIRS (Feb 2013 June 2015) Dr. Grit Braeseke IEGUS Institut
Aims of the study are: Evaluate the use of biomechanical operated orthoses in patients with spinal cord injury (SCI), concerning feasibility clinical outcome (functional and neuroglogic results) Rehabilitation success Patient acceptance by gender Cost and duration of rehabilitation
Incidence and prevalence of SCI in Germany Incidence: 1.500 to 1.800 new cases per year Prevalence: about 70.000 persons with SCI Severely handicapped persons with SCI (about17.000 persons): 4 500 4 000 3 500 3 000 2 500 2 000 1 500 1 000 500 Persons with SCI by age in 2011 bis 15 15-25 25-35 35-45 45-55 55-60 60-62 62-65 65-70 70-75 über 75 16 000 14 000 12 000 10 000 8 000 6 000 4 000 2 000 - Number of persons by degree of disability 50 60 70 80 90 100
Overview of substudies MMIRS substudy Clinical study (BMH) Health- and socio-economic study (IEGUS) perspective Individual/patient society benefit Body functions, Body structures Earning capacity Activities and participation Employment, Labour market cost Private expenses, Loss of earnings Cost of therapy, Services for participation
First results of the pilot clinical study with 4 chronic SCI patients: Treadmill-related changes: Increase of walking distance from a few metres up to one km Extension of walking time from few minutes up to 30 min Enhancement of walking speed from 0,6-0,8 km/h to 1,8-2,8 km/h Reduction of body weight relief from 30 50 % to 0 30 %
Clinical neurologic changes: 1 Patient: Switch from ASIA B to ASIA C 1 Patient: spasticity reduction Ashworth 3-4 to 2-3 All Patients: LEMS (lower extremities motor score) raised 2 points on average 1 Patient: better sensitivity at ASIA Sensory Score ASIA Impairment Description A complete no motor or sensory function is preserved in the sacral segments S4-S5 B incomplete sensory but not motor function is preserved below the neurological level C incomplete motor function is preserved below the neurological level and more than half of key muscles below the neurological level have a muscle grade of less than 3 D incomplete motor function is preserved below the neurological level and at least half of the key muscles below the neurological level have a muscle grade of 3 or more E Normal motor and sensory scores are normal
Significant changes in functional ability: All patients could reach time reduction at 10-m-walk-Test of about 50 %. All patients could pass the 6-minute-walk-Test (70-112m). Enhancements at the timed-up-and-go-test Increase of WISCI II Score of 2-3 points for 2 patients (Walking Index)
Health- and socio-economic evaluation Health economic effects Acceptability Usability, safety Gender specific issues Premarket approval and financing
Standardised patient questionnaire General data (Nr. 1-4), ICF-based part (Nr. 5-7) 128 Items observation schedule: start of training, week 6, 12, 24 No. Part Example Items 1 General Information Date, Patient-ID, therapist/attending physician 3 2 Personal data Sex, date of birth, family status, education, profession, ability to work, etc. 3 Health and life style subjective well-being, secondary diseases, private expenses, number of consultations etc. 4 Technical acceptance General acceptance and therapy-specific 21 5 Body functions mental functions, pain, functions of the immune and respiratory 41 system, metabolismetc. 6 Activities and participation General activities of daily living, mobility, self supply, partnership etc. 35 7 Environmental factors Products and technologies, support and relationships 10 8 10
Future prospects: possible fields of application Injuries of lower and upper legs fractures of the femoral neck Apoplexy Arthrosis Gonarthrosis Disseminated Sclerosis (MS) Assisted living 10
Future prospects: possible fields of application 20?? Sport and leisure Private use Heavy Work Assistance Ambient Assisted Living Rehabilitation - training centres 2015 Use outside of hospitals and medical centres 11
Findings of a study on assistive technologies for people in need for care (German Ministry of Health 2013) IT-platform to create networks of support SensFloor (fall detection) Devices with memory function (medication) Automatic cutoff for cooking devices Mobile assistive device to get up Toilet with washing function
Thank you for your attention! Dr. Grit Braeseke Head IEGUS - Institut für Europäische Gesundheits- und Sozialwirtschaft GmbH Reinhardtstr. 31 D-10117 Berlin Fon: +49 30/9831222-4, Fax: +49 30/9831222-5 E-Mail: braeseke@iegus.eu Internet: www.iegus.eu