초록 ▼

연구결과
필요성 및 목표
장시간 휠체어 및 침상 생활을 하는 척수손상 장애인 및 뇌졸중 환자 등 중증 장애인이 휠체어를 탄 상태에서 하지 운동 및 재활훈련을 할 수 있도록 하는 휠체어결합형 하지재활 훈련시스템에 대한 안전성 및 성능 평가 기술 마련이 필요함
방법 및 결과
국내외 관련 규격을 조사하여 휠체어결합형 하지재활훈련시스템의 성능 및 안전성 평가를 위한 종합 평가항목을 도출하고 산학연 전문가로 구성된 협의체를 통해 의견 수렴 후, 시험 검증하여 성능 및 안전성 평가 가이드라인(안)을 마련하였음
기대성

연구결과
필요성 및 목표
장시간 휠체어 및 침상 생활을 하는 척수손상 장애인 및 뇌졸중 환자 등 중증 장애인이 휠체어를 탄 상태에서 하지 운동 및 재활훈련을 할 수 있도록 하는 휠체어결합형 하지재활 훈련시스템에 대한 안전성 및 성능 평가 기술 마련이 필요함
방법 및 결과
국내외 관련 규격을 조사하여 휠체어결합형 하지재활훈련시스템의 성능 및 안전성 평가를 위한 종합 평가항목을 도출하고 산학연 전문가로 구성된 협의체를 통해 의견 수렴 후, 시험 검증하여 성능 및 안전성 평가 가이드라인(안)을 마련하였음
기대성과
신기술 의료기기인 휠체어결합형 하지재활훈련시스템의 평가 기술 마련 및 허가 심사 사전 지원

Abstract ▼

Domestic and overseas consumers requiring rehabilitation devices to improve quality of life such as those disabled or suffering from paralyzed limbs due to spinal injuries and strokes have increased in the past years as the use and benefits of these devices have also increased. Lower limb rehabilita

Domestic and overseas consumers requiring rehabilitation devices to improve quality of life such as those disabled or suffering from paralyzed limbs due to spinal injuries and strokes have increased in the past years as the use and benefits of these devices have also increased. Lower limb rehabilitation system coupled with wheelchair can support the movement of persons with severe disabilities. Improved digestion, blood circulation, and rehabilitation are expected with supported rehabilitation of lower limb by moving each joint in the lower limb. Domestic and overseas consumers requiring rehabilitation devices to improve quality of life such as those disabled or suffering from paralyzed limbs due to spinal injuries and strokes have increased in the past years as the use and benefits of these devices have also increased. In some developed countries, diverse devices supporting movement and rehabilitation of persons with severe disabilities have been developed and commercialized, but not a particular case has been promoted in Korea. No relevant evaluation technology has been prepared as well. Therefore, difficulties in future permit examination is foreseen. The permit examination needs to be urgently supported by developing Evaluation Guidelines for Ensuring Performance and Safety of Lower Limb Rehabilitation System Coupled with Wheelchair (draft) in order to help the disabled suffering from spinal cord injury, stroke, and other severe disabilities who cannot exercise lower limb and conduct rehabilitation by themselves. This study is to prepare the performance and safety evaluation items for the motorized wheelchair with added lower limb exercise functions in line with the international standards and to review the relevant feasibility of fabricating Guidelines (draft) for supporting the examination process and for promoting manufacturing of medical device satisfying the international standards. Development of evaluation guidelines for the lower limb rehabilitation system coupled with wheelchair for persons with severe disabilities is expected to be effective not only in preparing performance and safety evaluating technology for the future permission examination and follow-up management but also in improving the quality of life of the disabled through fast support of permission for new domestic state-of-art medical devices as well in improving the national image due to development of the relevant industry.