The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
研究概览
简要总结
The ATLET study will assess the effect of manual or robotic body-weight supported locomotor training of patients with stable motor incomplete spinal cord injury (SCI) on gait and overall ADL function as well as on estimated health care costs.
详细描述
There are approximately 100 new cases of spinal cord injuries (SCI) each year in Norway. Most of the SCI occur after traumatic accidents among young people and adults during the time of their productive life. Loss of walking and standing ability restricts their independent mobility and autonomy and severely impacts their quality of life.
The study has two arms: 1) manual locomotor training (Tromsø) and 2) robot assisted training (Oslo). Each study arm has 30 patients, randomized to receive standard care or intervention. The intervention group receives 60 days of intensive locomotor training over 6 months. Single-blind, before/after evaluation of effect will be performed at Sunnaas hospital using a standardized set of evaluation tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motor incomplete SCI grade AIS-C or -D
- •Age: 18 - 70 years
- •Body mass index of <30
- •Wheelchair dependent
- •At least 2 years since time of injury
- •Cognitively unaffected and motivated for locomotor training
- •Lives within driving distance of Oslo (< 70 km), if considered for the outpatient arm of the study.
排除标准
- •Complete SCI grade AIS-A or -B
- •Cognitively reduced
- •Age: under 18 years or above 71 years
- •Spasms and contractures which can prevent locomotor training
- •Changes in use of spasm reducing medication during intervention
- •Significant osteoporosis in spine and/or joints
- •Pregnancy (adequate contraceptive use is required of women in fertile age)
- •Physical limitations for the use of the robotic orthosis
- •Participation in other intensive training programs
- •Those who live 70 or more kilometers from the Oslo training center, will be enrolled in the Tromso arm of the study.
- •Other medical condition which can interfere with the training protocol
- •Previous knee- or hip replacement
研究组 & 干预措施
robot
30 persons with incomplete SCI who live within driving distance to Oslo and who meet the inclusion/exclusion criteria will be selected for randomization to robotic assisted training or control (conventional treatment). Intervention consists of locomotor training with robot for 60 days during 6 months period in an out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.
干预措施: Locomotor training with robot (Other)
manual assistance
30 persons with incomplete SCI who live outside driving distance to Oslo and who meet inclusion/exclusion criteria will be selected for manually assisted training in Tromsø or control (conventional treatment). Intervention consists of 60 days locomotor training with manual assistance during 6 months period in an in-patient setting. Training 2 times per day total 120 minutes. Control group receives conventional training/treatment.
干预措施: Locomotor training with manual assistance (Other)
结局指标
主要结局
Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
时间窗: 2 - 4 weeks before and after intervention
Locomotor training is cost-effective rehabilitation.
时间窗: 2-4 weeks before and after intervention
To assess whether locomotor training with body-weight support in patients with motor incomplete SCI results in full or partial recovery of the ability to walk and/or stand.
时间窗: 2-4 weeks before and after intervention
次要结局
- Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in balance(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in walking function(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in sensibility below the level of injury(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in quality of life(2-4 weeks before and after intervention)
- Locomotor training in persons with motor incomplete SCI will lead to change in use of personal assistant or home health nurse(2-4 weeks before and after intervention)
研究者
Synnove Knutsen
MD, PhD, Professor
North Norway Rehabilitation Center