DRKS00023857已完成不适用
Single-blinded systematic data analysis to plausibly demonstrate one or more positive health effects of Orthelligent as a digital health application in telerehabilitation after knee surgery. - Orthelligent telematic Rehabilitation System Outcome, ORSOME - Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OPED GmbH
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 14 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Knee injury / damage to be treated within 6 months prior to use of the Orthelligent.
- •- Use of the Orthelligent or patient with treatment of a knee joint injury with an orthosis of the manufacturer in the same period for the following indications:
- •- Diabetes mell.: E11.40, E11.41 E14.40, E14.41, E14.80, E14.81,
- •- (apoplexy) I61, I63, I64, I69,
- •- Spinal muscular atrophy: G12.0/1/2/8/9
- •- Deg. Basal ganglia diseases: G23.0/2/3/8/9
- •- Multiple sclerosis: G35.0/1/2/3/10/11/20/21/30/31/9
- •- Hereditary and idiopathic neuropathy: G60.0/1/2/3/8/9
- •- Primary myopathies: G71
- •- Other myopathies: G72.0/1/2/3/4/8//9
- •- Infantile cerebral palsy: G80.1/2/3/4/8/9
- •- (hemiparesis) G81.0 /1/9
- •- Spinal cord damage: G82.6
- •- (disorders of the RM) G95,
- •- Arthropathies: M00 - M25 (each for lower extremities) *.*5-*9
- •- Purulent arthritis: M00 (each for lower extremities) M00.*5-*9
- •- Direct joint infections in infectious and parasitic diseases classified elsewhere: (each for lower extremities) M01.*5-*9
- •- Reactive arthritides: (each for lower extremities) M03.*5-*9
- •- Inflammatory polyarthropathies (each for lower extremities) M05-14.*5-*9
- •- Polyarthrosis: M15.0/1/2/3/4/8/9
- •- Gonarthrosis: M17.0/1-5/9
- •- Other osteoarthritis: (each for lower extremities) M19.*5-*9
- •- Acquired deformities of extremities: (each for lower extremities) M21.*5-*9
- •- Diseases of the patella: M22.0-4/8/9
- •- Internal damage of knee joint: M23.*
- •- Other more specifically described joint damage: M24.*5-*9
- •- Other joint disease, not elsewhere classified: (each for lower extremities) M25.*5-*9: (each for lower extremities) M13.*5-9
- •- Joint disease, not elsewhere classified: M25.05-09/15-19/25-29/35-39/45-49/55-59/65-69/75-79/85-89/95-99
- •- Systemic diseases of connective tissue in diseases classified elsewhere: M36.0/1/2/3/4/5*
- •- Spondylopathies: M48.06/07/08/09/10/16/17/18/19/26-29/36-39/46-49/56-59/86-89/96-99
- •- Herniated disc: M51.0-4/8/9
- •- Other diseases of the spine and back, not elsewhere classified: M53.*6-*9
- •- Other muscular diseases: M62.06, M62.15/16/17, M62.25/26/27/28, M62.50/55/56/57/58/59; M62.65 - 69, M62.80/85-89, M62.90/95 -99
- •- Tendon rupture US: M66
- •- Gait complaints: R36.2
- •- (other NMS) R29.9,
- •- Condition after ligament injuries knee joint (S83.40, S83.43, S83.44, S83.50, S83.53, S83.54, S83.; 5-813)
- •- Condition after meniscal tears (S83.2; 5-812)
- •- Condition after fractures near the knee (S72.4-, S82.0, S82.1-;5-78.-, 5-79.-, 5-80.-, 5-81)
- •- Contusions knee/lower leg (S80.0, S80.1)
- •- Condition after distortions knee joint (S83.41, S83.42, S83.51, S83.52, S83.6)
- •- Condition after open injuries, thigh, knee, lower leg (superficial) (S71.1, S71.7, S80.7, S80.81, S80.82, S80.84, S80.88, S81.0, S81.9)
- •- Condition after muscle or tendon injuries (thigh, lower leg) (S76.1, S76.2, S76.3, S76.4, S86.1, S86.2, S86.3, S86.7, S86.8, S86.9)
- •- Condition after cartilage injuries knee joint (S83.3)
- •- Condition after luxations patella/knee joint (S83.0, S83.1)
- •- Signed informed consent form
排除标准
- •In general:
- •- Incapacity to consent.
- •- Lack of understanding of explanation, informed consent, and study procedures
- •- Diseases/injuries that also affect the contralateral side
- •- Pronounced clinically relevant neurological diseases (degenerative, diabetic, ischemic, etc.) with influence on gait pattern
- •- Muscular underlying diseases
- •- Clinically relevant pAVK (from stage IIb according to Fontaine)
- •- Restriction of the contralateral side
- •- Further injuries or amputations of the lower extremities during the observation period
- •- Influencing factors that no longer allow the assessment of rehabilitation measures on knee joint function
- •- Less than 80% of the questions not answered or not answered plausibly
研究者
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