Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change in disability of the arm, shoulder and hand (DASH)
研究概览
简要总结
In this study, patients with upper arm fracture will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks on the injured arm in addition to conventional physio- and occupational therapy. The supportive treatment and execution of specific exercises on the Armeo®Spring should lead to improved recovery of function and mobility of the upper arm compared to conservatively treated patients.
详细描述
60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical treatment will be recruited in three different clinics in Germany and randomised into an intervention and a control group. Participants will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and hand (DASH), as well as the range of motion of the affected arm (goniometer measurement), visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up directly after intervention will assess disability of the arm, shoulder and hand (DASH), the range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by a postal follow-up. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11
- •movement-stable fracture
- •Inclusion between the fourth and the seventh week after surgery
排除标准
- •limited cognition as defined by a score in Short-Orientation-Memory-Concentration Test (SOMC) less than 10 points
- •inadequate level of pain during movement of the affected shoulder joint (pain score >5 on a visual analogue pain scale)
- •strongly limited vision or hearing
- •heart failure (New York Heart Association stage III-IV) or COPD (Chronic Obstructive Pulmonary Disease) Gold stage III-IV
- •walking speed <0.8m/sec
- •isolated tuberculum majus fracture of the humerus (AO 11, A1)
- •fractures with involvement of the glenoid cavity
- •double fractures
- •injury of the plexus or the axillaris nerve
结局指标
主要结局
Change in disability of the arm, shoulder and hand (DASH)
时间窗: DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change
subjective questionnaire for assessing the disability of the arm, shoulder and hand
次要结局
- Change in ROM(ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change)
- Change in grip strength(grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change)
- Change in the WMFT-O(WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change)
研究者
Corinna Nerz
Research associate
Robert Bosch Gesellschaft für Medizinische Forschung mbH